Drug Facts ALLERGY 1 Tamper Evident: do not use if foil ...€¦ · Front Layer 1 of 3 3 1 9 N...

24
Front Layer 1 of 3 3 0378-3635-01 9 N MYLAN NDC 0378-3635-01 100 TABLETS RM-AR3635A1 ® Cetirizine Hydrochloride Tablets 5 mg antihistamine Indoor & Outdoor Allergies 24 Hour Relief of runny nose sneezing itchy, watery eyes itching of the nose or throat Drug Facts Active Ingredient (in each tablet) Purpose Cetirizine Hydrochloride 5 mg . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Antihistamine Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat Warnings Do not use if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine. Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose. ALLERGY OPEN FOR FULL LABELING BLACK 200 RED 306 BLUE FONTS: Trade Gothic Cond. #18; Trade Gothic Bold Cond. #20; Trade Gothic Bold Cond. Italics #20 Drug Facts: 9 pt Headers 7 pt Body Text 6 pt Drug Facts (continued) 8 pt Leading 7 pt/6.5 pt Bullets 5 pt Frames 1.5 pt Bars 1 pt Rules 0.5 pt Tamper Evident: do not use if foil seal under cap is missing, open or broken.

Transcript of Drug Facts ALLERGY 1 Tamper Evident: do not use if foil ...€¦ · Front Layer 1 of 3 3 1 9 N...

Page 1: Drug Facts ALLERGY 1 Tamper Evident: do not use if foil ...€¦ · Front Layer 1 of 3 3 1 9 N MYLAN NDC 0378-3635-01 100 TABLETS RM-AR3635A1 ® Cetirizine Hydrochloride Tablets 5mg

Front Layer 1 of 3

30378-3635-01

9N

MYLAN

NDC 0378-3635-01

100 TABLETS RM-AR3635A1

®

Cetirizine HydrochlorideTablets 5 mgantihistamineIndoor & Outdoor Allergies24 Hour Relief of � runny nose � sneezing � itchy, watery eyes� itching of the nose or throat

Drug FactsActive Ingredient (in each tablet) PurposeCetirizine Hydrochloride 5 mg . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . AntihistamineUses temporarily relieves these symptoms due to hay fever or other upper respiratoryallergies:� runny nose � sneezing � itchy, watery eyes� itching of the nose or throat

WarningsDo not use if you have ever had an allergic reaction to this product or any of itsingredients or to an antihistamine containing hydroxyzine.Ask a doctor before use if you have liver or kidney disease. Your doctor shoulddetermine if you need a different dose. �

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Drug Facts: 9 ptHeaders 7 ptBody Text 6 ptDrug Facts (continued) 8 ptLeading 7 pt/6.5 ptBullets 5 ptFrames 1.5 ptBars 1 ptRules 0.5 pt

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Page 2: Drug Facts ALLERGY 1 Tamper Evident: do not use if foil ...€¦ · Front Layer 1 of 3 3 1 9 N MYLAN NDC 0378-3635-01 100 TABLETS RM-AR3635A1 ® Cetirizine Hydrochloride Tablets 5mg

Back of Front Layer 2 2 of 3

Drug Facts (continued)Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.

When using this product� drowsiness may occur � avoid alcoholic drinks� alcohol, sedatives, and tranquilizers may increase drowsiness� be careful when driving a motor vehicle or operating machineryStop use and ask a doctor if an allergic reaction to this product occurs.Seek medical help right away.If pregnant or breast-feeding:� if breast-feeding: not recommended� if pregnant: ask a health professional before use.Keep out of reach of children. In case of overdose, get medical help orcontact a Poison Control Center right away. �

Drug Facts (continued)Directionsadults and children 1 to 2 tablets once daily depending upon6 years and over severity of symptoms; do not take more than

2 tablets in 24 hours.adults 65 years 1 tablet once a day; do not take more thanand over 1 tablet in 24 hourschildren under ask a doctor6 years of ageconsumers with liver ask a doctoror kidney disease

BLACK

FONTS: Trade Gothic Cond. #18; Trade Gothic BoldCond. #20; Trade Gothic Bold Cond. Italics #20

Drug Facts: 9 ptHeaders 7 ptBody Text 6 ptDrug Facts (continued) 8 ptLeading 7 pt/6.5 ptBullets 5 ptFrames 1.5 ptBars 1 ptRules 0.5 pt

Page 3: Drug Facts ALLERGY 1 Tamper Evident: do not use if foil ...€¦ · Front Layer 1 of 3 3 1 9 N MYLAN NDC 0378-3635-01 100 TABLETS RM-AR3635A1 ® Cetirizine Hydrochloride Tablets 5mg

Base Layer 3 of 3

PERMANENT GLUE REMOVABLE GLUE

Drug Facts (continued)Other information� store between 20° to 25°C (68° to 77°F)

lnactive ingredientsanhydrous lactose, colloidal silicon dioxide, hypromellose, magnesiumstearate, microcrystalline cellulose, polydextrose, polyethylene glycol, sodiumlauryl sulfate, titanium dioxide, and triacetin

Questions? call 1-877-446-3679

Mylan Pharmaceuticals Inc.Morgantown, WV 26505

BLACK

MYLAN

NDC 0378-3635-01

100 TABLETS RM-AR3635A1

®

Cetirizine HydrochlorideTablets 5 mgantihistamineIndoor & Outdoor Allergies24 Hour Relief of � runny nose � sneezing � itchy, watery eyes� itching of the nose or throat

ALLERGY

FONTS: Trade Gothic Cond. #18; Trade Gothic BoldCond. #20; Trade Gothic Bold Cond. Italics #20

Drug Facts: 9 ptHeaders 7 ptBody Text 6 ptDrug Facts (continued) 8 ptLeading 7 pt/6.5 ptBullets 5 ptFrames 1.5 ptBars 1 ptRules 0.5 pt

Page 4: Drug Facts ALLERGY 1 Tamper Evident: do not use if foil ...€¦ · Front Layer 1 of 3 3 1 9 N MYLAN NDC 0378-3635-01 100 TABLETS RM-AR3635A1 ® Cetirizine Hydrochloride Tablets 5mg

Front Layer 1 of 3

30378-3635-05

7N

MYLAN

NDC 0378-3635-05

500 TABLETS RM-AR3635B1

®

Cetirizine HydrochlorideTablets 5 mgantihistamineIndoor & Outdoor Allergies24 Hour Relief of � runny nose � sneezing � itchy, watery eyes� itching of the nose or throat

Drug FactsActive Ingredient (in each tablet) PurposeCetirizine Hydrochloride 5 mg . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . AntihistamineUses temporarily relieves these symptoms due to hay fever or other upper respiratoryallergies:� runny nose � sneezing � itchy, watery eyes� itching of the nose or throat

WarningsDo not use if you have ever had an allergic reaction to this product or any of itsingredients or to an antihistamine containing hydroxyzine.Ask a doctor before use if you have liver or kidney disease. Your doctor shoulddetermine if you need a different dose. �

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Back of Front Layer 2 2 of 3

Drug Facts (continued)Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.

When using this product� drowsiness may occur � avoid alcoholic drinks� alcohol, sedatives, and tranquilizers may increase drowsiness� be careful when driving a motor vehicle or operating machineryStop use and ask a doctor if an allergic reaction to this product occurs.Seek medical help right away.If pregnant or breast-feeding:� if breast-feeding: not recommended� if pregnant: ask a health professional before use.Keep out of reach of children. In case of overdose, get medical help orcontact a Poison Control Center right away. �

Drug Facts (continued)Directionsadults and children 1 to 2 tablets once daily depending upon6 years and over severity of symptoms; do not take more than

2 tablets in 24 hours.adults 65 years 1 tablet once a day; do not take more thanand over 1 tablet in 24 hourschildren under ask a doctor6 years of ageconsumers with liver ask a doctoror kidney disease

BLACK

FONTS: Trade Gothic Cond. #18; Trade Gothic BoldCond. #20; Trade Gothic Bold Cond. Italics #20

Drug Facts: 9 ptHeaders 7 ptBody Text 6 ptDrug Facts (continued) 8 ptLeading 7 pt/6.5 ptBullets 5 ptFrames 1.5 ptBars 1 ptRules 0.5 pt

Page 6: Drug Facts ALLERGY 1 Tamper Evident: do not use if foil ...€¦ · Front Layer 1 of 3 3 1 9 N MYLAN NDC 0378-3635-01 100 TABLETS RM-AR3635A1 ® Cetirizine Hydrochloride Tablets 5mg

Base Layer 3 of 3

PERMANENT GLUE REMOVABLE GLUE

Drug Facts (continued)Other information� store between 20° to 25°C (68° to 77°F)

lnactive ingredientsanhydrous lactose, colloidal silicon dioxide, hypromellose, magnesiumstearate, microcrystalline cellulose, polydextrose, polyethylene glycol, sodiumlauryl sulfate, titanium dioxide, and triacetin

Questions? call 1-877-446-3679

Mylan Pharmaceuticals Inc.Morgantown, WV 26505

BLACK

MYLAN

NDC 0378-3635-05

500 TABLETS RM-AR3635B1

®

Cetirizine HydrochlorideTablets 5 mgantihistamineIndoor & Outdoor Allergies24 Hour Relief of � runny nose � sneezing � itchy, watery eyes� itching of the nose or throat

ALLERGY

FONTS: Trade Gothic Cond. #18; Trade Gothic BoldCond. #20; Trade Gothic Bold Cond. Italics #20

Drug Facts: 9 ptHeaders 7 ptBody Text 6 ptDrug Facts (continued) 8 ptLeading 7 pt/6.5 ptBullets 5 ptFrames 1.5 ptBars 1 ptRules 0.5 pt

Page 7: Drug Facts ALLERGY 1 Tamper Evident: do not use if foil ...€¦ · Front Layer 1 of 3 3 1 9 N MYLAN NDC 0378-3635-01 100 TABLETS RM-AR3635A1 ® Cetirizine Hydrochloride Tablets 5mg

Front Layer 1 of 3

30378-3637-01

3N

MYLAN

NDC 0378-3637-01

100 TABLETS RM-AR3637A1

®

Cetirizine HydrochlorideTablets 10 mgantihistamineIndoor & Outdoor Allergies24 Hour Relief of � runny nose � sneezing � itchy, watery eyes� itching of the nose or throat

Drug FactsActive Ingredient (in each tablet) PurposeCetirizine Hydrochloride 10 mg . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . AntihistamineUses temporarily relieves these symptoms due to hay fever or other upper respiratoryallergies:� runny nose � sneezing � itchy, watery eyes� itching of the nose or throat

WarningsDo not use if you have ever had an allergic reaction to this product or any of itsingredients or to an antihistamine containing hydroxyzine.Ask a doctor before use if you have liver or kidney disease. Your doctor shoulddetermine if you need a different dose. �

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Drug Facts: 9 ptHeaders 7 ptBody Text 6 ptDrug Facts (continued) 8 ptLeading 7 pt/6.5 ptBullets 5 ptFrames 1.5 ptBars 1 ptRules 0.5 pt

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Back of Front Layer 2 2 of 3

Drug Facts (continued)Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.

When using this product� drowsiness may occur � avoid alcoholic drinks� alcohol, sedatives, and tranquilizers may increase drowsiness� be careful when driving a motor vehicle or operating machineryStop use and ask a doctor if an allergic reaction to this product occurs.Seek medical help right away.If pregnant or breast-feeding:� if breast-feeding: not recommended� if pregnant: ask a health professional before use.Keep out of reach of children. In case of overdose, get medical help orcontact a Poison Control Center right away. �

Drug Facts (continued)Directionsadults and children one 10 mg tablet once daily; do not take6 years and over more than one 10 mg tablet in 24 hours.

A 5 mg product may be appropriate forless severe symptoms.

adults 65 years and over ask a doctorchildren under ask a doctor6 years of ageconsumers with liver ask a doctoror kidney disease

BLACK

FONTS: Trade Gothic Cond. #18; Trade Gothic BoldCond. #20; Trade Gothic Bold Cond. Italics #20

Drug Facts: 9 ptHeaders 7 ptBody Text 6 ptDrug Facts (continued) 8 ptLeading 7 pt/6.5 ptBullets 5 ptFrames 1.5 ptBars 1 ptRules 0.5 pt

Page 9: Drug Facts ALLERGY 1 Tamper Evident: do not use if foil ...€¦ · Front Layer 1 of 3 3 1 9 N MYLAN NDC 0378-3635-01 100 TABLETS RM-AR3635A1 ® Cetirizine Hydrochloride Tablets 5mg

Base Layer 3 of 3

PERMANENT GLUE REMOVABLE GLUE

Drug Facts (continued)Other information� store between 20° to 25°C (68° to 77°F)

lnactive ingredientsanhydrous lactose, colloidal silicon dioxide, hypromellose, magnesiumstearate, microcrystalline cellulose, polydextrose, polyethylene glycol, sodiumlauryl sulfate, titanium dioxide, and triacetin

Questions? call 1-877-446-3679

Mylan Pharmaceuticals Inc.Morgantown, WV 26505

BLACK

MYLAN

NDC 0378-3637-01

100 TABLETS RM-AR3637A1

®

Cetirizine HydrochlorideTablets 10 mgantihistamineIndoor & Outdoor Allergies24 Hour Relief of � runny nose � sneezing � itchy, watery eyes� itching of the nose or throat

ALLERGY

FONTS: Trade Gothic Cond. #18; Trade Gothic BoldCond. #20; Trade Gothic Bold Cond. Italics #20

Drug Facts: 9 ptHeaders 7 ptBody Text 6 ptDrug Facts (continued) 8 ptLeading 7 pt/6.5 ptBullets 5 ptFrames 1.5 ptBars 1 ptRules 0.5 pt

Page 10: Drug Facts ALLERGY 1 Tamper Evident: do not use if foil ...€¦ · Front Layer 1 of 3 3 1 9 N MYLAN NDC 0378-3635-01 100 TABLETS RM-AR3635A1 ® Cetirizine Hydrochloride Tablets 5mg

Front Layer 1 of 3

30378-3637-05

1N

MYLAN

NDC 0378-3637-05

500 TABLETS RM-AR3637B1

®

Cetirizine HydrochlorideTablets 10 mgantihistamineIndoor & Outdoor Allergies24 Hour Relief of � runny nose � sneezing � itchy, watery eyes� itching of the nose or throat

Drug FactsActive Ingredient (in each tablet) PurposeCetirizine Hydrochloride 10 mg . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . AntihistamineUses temporarily relieves these symptoms due to hay fever or other upper respiratoryallergies:� runny nose � sneezing � itchy, watery eyes� itching of the nose or throat

WarningsDo not use if you have ever had an allergic reaction to this product or any of itsingredients or to an antihistamine containing hydroxyzine.Ask a doctor before use if you have liver or kidney disease. Your doctor shoulddetermine if you need a different dose. �

ALLERGY

OP

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FO

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ULL

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BE

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BLACK 354 GREEN 306 BLUE

FONTS: Trade Gothic Cond. #18; Trade Gothic BoldCond. #20; Trade Gothic Bold Cond. Italics #20

Drug Facts: 9 ptHeaders 7 ptBody Text 6 ptDrug Facts (continued) 8 ptLeading 7 pt/6.5 ptBullets 5 ptFrames 1.5 ptBars 1 ptRules 0.5 pt

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Back of Front Layer 2 2 of 3

Drug Facts (continued)Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.

When using this product� drowsiness may occur � avoid alcoholic drinks� alcohol, sedatives, and tranquilizers may increase drowsiness� be careful when driving a motor vehicle or operating machineryStop use and ask a doctor if an allergic reaction to this product occurs.Seek medical help right away.If pregnant or breast-feeding:� if breast-feeding: not recommended� if pregnant: ask a health professional before use.Keep out of reach of children. In case of overdose, get medical help orcontact a Poison Control Center right away. �

Drug Facts (continued)Directionsadults and children one 10 mg tablet once daily; do not take6 years and over more than one 10 mg tablet in 24 hours.

A 5 mg product may be appropriate forless severe symptoms.

adults 65 years and over ask a doctorchildren under ask a doctor6 years of ageconsumers with liver ask a doctoror kidney disease

BLACK

FONTS: Trade Gothic Cond. #18; Trade Gothic BoldCond. #20; Trade Gothic Bold Cond. Italics #20

Drug Facts: 9 ptHeaders 7 ptBody Text 6 ptDrug Facts (continued) 8 ptLeading 7 pt/6.5 ptBullets 5 ptFrames 1.5 ptBars 1 ptRules 0.5 pt

Page 12: Drug Facts ALLERGY 1 Tamper Evident: do not use if foil ...€¦ · Front Layer 1 of 3 3 1 9 N MYLAN NDC 0378-3635-01 100 TABLETS RM-AR3635A1 ® Cetirizine Hydrochloride Tablets 5mg

Base Layer 3 of 3

PERMANENT GLUE REMOVABLE GLUE

Drug Facts (continued)Other information� store between 20° to 25°C (68° to 77°F)

lnactive ingredientsanhydrous lactose, colloidal silicon dioxide, hypromellose, magnesiumstearate, microcrystalline cellulose, polydextrose, polyethylene glycol, sodiumlauryl sulfate, titanium dioxide, and triacetin

Questions? call 1-877-446-3679

Mylan Pharmaceuticals Inc.Morgantown, WV 26505

BLACK

MYLAN

NDC 0378-3637-05

500 TABLETS RM-AR3637B1

®

Cetirizine HydrochlorideTablets 10 mgantihistamineIndoor & Outdoor Allergies24 Hour Relief of � runny nose � sneezing � itchy, watery eyes� itching of the nose or throat

ALLERGY

FONTS: Trade Gothic Cond. #18; Trade Gothic BoldCond. #20; Trade Gothic Bold Cond. Italics #20

Drug Facts: 9 ptHeaders 7 ptBody Text 6 ptDrug Facts (continued) 8 ptLeading 7 pt/6.5 ptBullets 5 ptFrames 1.5 ptBars 1 ptRules 0.5 pt

Page 13: Drug Facts ALLERGY 1 Tamper Evident: do not use if foil ...€¦ · Front Layer 1 of 3 3 1 9 N MYLAN NDC 0378-3635-01 100 TABLETS RM-AR3635A1 ® Cetirizine Hydrochloride Tablets 5mg

Front Layer 1 of 3

30378-3635-01

9N

MYLAN

NDC 0378-3635-01

100 TABLETS RM-H3635A1

®

Cetirizine HydrochlorideTablets 5 mgantihistamine

Relief ofITCHINGDue to Hives

Tamper Evident: do not use if foil seal under capis missing, open or broken

Drug FactsActive Ingredient (in each tablet) PurposeCetirizine Hydrochloride 5 mg . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . AntihistamineUse relieves itching due to hives (urticaria). This product will not prevent hives or an allergic skin reaction fromoccurring.WarningsSevere Allergy Warning: Get emergency help immediately if you have hives along with any of the following symptoms:� trouble swallowing � swelling of tongue � trouble speaking � wheezing or problems breathing� dizziness or loss of consciousness � swelling in or around mouth � droolingThese symptoms may be signs of anaphylactic shock. This condition can be life threatening if not treated by a healthprofessional immediately. Symptoms of anaphylactic shock may occur when hives first appear or up to a few hours later.Not a Substitute for Epinephrine. If your doctor has prescribed an epinephrine injector for “anaphylaxis” or severeallergy symptoms that could occur with your hives, never use this product as a substitute for the epinephrine injector. �

OP

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HIVESRelief

24HOUR

FONTS: Trade Gothic Cond. #18; Trade Gothic BoldCond. #20; Trade Gothic Bold Cond. Italics #20

Drug Facts: 9 ptHeaders 7 ptBody Text 6 ptDrug Facts (continued) 8 ptLeading 7 pt/6.5 ptBullets 5 ptFrames 1.5 ptBars 1 ptRules 0.5 pt

Page 14: Drug Facts ALLERGY 1 Tamper Evident: do not use if foil ...€¦ · Front Layer 1 of 3 3 1 9 N MYLAN NDC 0378-3635-01 100 TABLETS RM-AR3635A1 ® Cetirizine Hydrochloride Tablets 5mg

Back of Front Layer 2 2 of 3

Drug Facts (continued)If you have been prescribed an epinephrine injector, you should carry it with you at all times.Do not use� to prevent hives from any known cause such as:

� foods � insect stings � medicines � latex or rubber glovesbecause this product will not stop hives from occurring. Avoiding the cause of yourhives is the only way to prevent them. Hives can sometimes be serious. If you do notknow the cause of your hives, see your doctor for a medical exam. Your doctor may beable to help you find a cause.

� if you have ever had an allergic reaction to this product or any of its ingredients or toan antihistamine containing hydroxyzine.

Ask a doctor before use if you have� liver or kidney disease. Your doctor should determine if you need a different dose.� hives that are an unusual color, look bruised or blistered � hives that do not itch �

Drug Facts (continued)Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.When using this product� drowsiness may occur � avoid alcoholic drinks� alcohol, sedatives, and tranquilizers may increase drowsiness� be careful when driving a motor vehicle or operating machineryStop use and ask a doctor if� an allergic reaction to this product occurs. Seek medical help right away.� symptoms do not improve after 3 days of treatment� the hives have lasted more than 6 weeksIf pregnant or breast-feeding:� if breast-feeding: not recommended� if pregnant: ask a health professional before use. �

BLACK

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Drug Facts: 9 ptHeaders 7 ptBody Text 6 ptDrug Facts (continued) 8 ptLeading 7 pt/6.5 ptBullets 5 ptFrames 1.5 ptBars 1 ptRules 0.5 pt

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Base Layer 3 of 3

PERMANENT GLUE REMOVABLE GLUE

Drug Facts (continued)Keep out of reach of children. In case of overdose, get medicalhelp or contact a Poison Control Center right away.

Directionsadults and children 1 to 2 tablets once daily depending6 years and over upon severity of symptoms; do not

take more than 2 tablets in 24 hours.adults 65 years and over 1 tablet once a day; do not take

more than 1 tablet in 24 hourschildren under 6 years of age ask a doctorconsumers with liver ask a doctoror kidney disease �

BLACK

Drug Facts (continued)Other information� store between 20° to 25°C (68° to 77°F)

lnactive ingredientsanhydrous lactose, colloidal silicon dioxide,hypromellose, magnesium stearate,microcrystalline cellulose, polydextrose,polyethylene glycol, sodium lauryl sulfate, titaniumdioxide, and triacetin

Questions? call 1-877-446-3679Mylan Pharmaceuticals Inc.Morgantown, WV 26505

FONTS: Trade Gothic Cond. #18; Trade Gothic BoldCond. #20; Trade Gothic Bold Cond. Italics #20

Drug Facts: 9 ptHeaders 7 ptBody Text 6 ptDrug Facts (continued) 8 ptLeading 7 pt/6.5 ptBullets 5 ptFrames 1.5 ptBars 1 ptRules 0.5 pt

MYLAN

NDC 0378-3635-01

100 TABLETS RM-H3635A1

®

Cetirizine HydrochlorideTablets 5 mgantihistamine

Relief ofITCHINGDue to Hives

Tamper Evident: do not use if foil seal under capis missing, open or broken

HIVESRelief

24HOUR

Page 16: Drug Facts ALLERGY 1 Tamper Evident: do not use if foil ...€¦ · Front Layer 1 of 3 3 1 9 N MYLAN NDC 0378-3635-01 100 TABLETS RM-AR3635A1 ® Cetirizine Hydrochloride Tablets 5mg

Front Layer 1 of 3

30378-3635-05

7N

MYLAN

NDC 0378-3635-05

500 TABLETS RM-H3635B1

®

Cetirizine HydrochlorideTablets 5 mgantihistamine

Relief ofITCHINGDue to Hives

Tamper Evident: do not use if foil seal under capis missing, open or broken

Drug FactsActive Ingredient (in each tablet) PurposeCetirizine Hydrochloride 5 mg . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . AntihistamineUse relieves itching due to hives (urticaria). This product will not prevent hives or an allergic skin reaction fromoccurring.WarningsSevere Allergy Warning: Get emergency help immediately if you have hives along with any of the following symptoms:� trouble swallowing � swelling of tongue � trouble speaking � wheezing or problems breathing� dizziness or loss of consciousness � swelling in or around mouth � droolingThese symptoms may be signs of anaphylactic shock. This condition can be life threatening if not treated by a healthprofessional immediately. Symptoms of anaphylactic shock may occur when hives first appear or up to a few hours later.Not a Substitute for Epinephrine. If your doctor has prescribed an epinephrine injector for “anaphylaxis” or severeallergy symptoms that could occur with your hives, never use this product as a substitute for the epinephrine injector. �

OP

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ULL

LA

BE

LIN

G�

BLACK PANT. PURPLE 306 BLUE

HIVESRelief

24HOUR

FONTS: Trade Gothic Cond. #18; Trade Gothic BoldCond. #20; Trade Gothic Bold Cond. Italics #20

Drug Facts: 9 ptHeaders 7 ptBody Text 6 ptDrug Facts (continued) 8 ptLeading 7 pt/6.5 ptBullets 5 ptFrames 1.5 ptBars 1 ptRules 0.5 pt

Page 17: Drug Facts ALLERGY 1 Tamper Evident: do not use if foil ...€¦ · Front Layer 1 of 3 3 1 9 N MYLAN NDC 0378-3635-01 100 TABLETS RM-AR3635A1 ® Cetirizine Hydrochloride Tablets 5mg

Back of Front Layer 2 2 of 3

Drug Facts (continued)If you have been prescribed an epinephrine injector, you should carry it with you at all times.Do not use� to prevent hives from any known cause such as:

� foods � insect stings � medicines � latex or rubber glovesbecause this product will not stop hives from occurring. Avoiding the cause of yourhives is the only way to prevent them. Hives can sometimes be serious. If you do notknow the cause of your hives, see your doctor for a medical exam. Your doctor may beable to help you find a cause.

� if you have ever had an allergic reaction to this product or any of its ingredients or toan antihistamine containing hydroxyzine.

Ask a doctor before use if you have� liver or kidney disease. Your doctor should determine if you need a different dose.� hives that are an unusual color, look bruised or blistered � hives that do not itch �

Drug Facts (continued)Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.When using this product� drowsiness may occur � avoid alcoholic drinks� alcohol, sedatives, and tranquilizers may increase drowsiness� be careful when driving a motor vehicle or operating machineryStop use and ask a doctor if� an allergic reaction to this product occurs. Seek medical help right away.� symptoms do not improve after 3 days of treatment� the hives have lasted more than 6 weeksIf pregnant or breast-feeding:� if breast-feeding: not recommended� if pregnant: ask a health professional before use. �

BLACK

FONTS: Trade Gothic Cond. #18; Trade Gothic BoldCond. #20; Trade Gothic Bold Cond. Italics #20

Drug Facts: 9 ptHeaders 7 ptBody Text 6 ptDrug Facts (continued) 8 ptLeading 7 pt/6.5 ptBullets 5 ptFrames 1.5 ptBars 1 ptRules 0.5 pt

Page 18: Drug Facts ALLERGY 1 Tamper Evident: do not use if foil ...€¦ · Front Layer 1 of 3 3 1 9 N MYLAN NDC 0378-3635-01 100 TABLETS RM-AR3635A1 ® Cetirizine Hydrochloride Tablets 5mg

Base Layer 3 of 3

PERMANENT GLUE REMOVABLE GLUE

Drug Facts (continued)Keep out of reach of children. In case of overdose, get medicalhelp or contact a Poison Control Center right away.

Directionsadults and children 1 to 2 tablets once daily depending6 years and over upon severity of symptoms; do not

take more than 2 tablets in 24 hours.adults 65 years and over 1 tablet once a day; do not take

more than 1 tablet in 24 hourschildren under 6 years of age ask a doctorconsumers with liver ask a doctoror kidney disease �

BLACK

Drug Facts (continued)Other information� store between 20° to 25°C (68° to 77°F)

lnactive ingredientsanhydrous lactose, colloidal silicon dioxide,hypromellose, magnesium stearate,microcrystalline cellulose, polydextrose,polyethylene glycol, sodium lauryl sulfate, titaniumdioxide, and triacetin

Questions? call 1-877-446-3679Mylan Pharmaceuticals Inc.Morgantown, WV 26505

FONTS: Trade Gothic Cond. #18; Trade Gothic BoldCond. #20; Trade Gothic Bold Cond. Italics #20

Drug Facts: 9 ptHeaders 7 ptBody Text 6 ptDrug Facts (continued) 8 ptLeading 7 pt/6.5 ptBullets 5 ptFrames 1.5 ptBars 1 ptRules 0.5 pt

MYLAN

NDC 0378-3635-05

500 TABLETS RM-H3635B1

®

Cetirizine HydrochlorideTablets 5 mgantihistamine

Relief ofITCHINGDue to Hives

Tamper Evident: do not use if foil seal under capis missing, open or broken

HIVESRelief

24HOUR

Page 19: Drug Facts ALLERGY 1 Tamper Evident: do not use if foil ...€¦ · Front Layer 1 of 3 3 1 9 N MYLAN NDC 0378-3635-01 100 TABLETS RM-AR3635A1 ® Cetirizine Hydrochloride Tablets 5mg

Front Layer 1 of 3

30378-3637-01

3N

MYLAN

NDC 0378-3637-01

100 TABLETS RM-H3637A1

®

Cetirizine HydrochlorideTablets 10 mgantihistamine

Relief ofITCHINGDue to Hives

Tamper Evident: do not use if foil seal under capis missing, open or broken

Drug FactsActive Ingredient (in each tablet) PurposeCetirizine Hydrochloride 10 mg . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . AntihistamineUse relieves itching due to hives (urticaria). This product will not prevent hives or an allergic skin reaction fromoccurring.WarningsSevere Allergy Warning: Get emergency help immediately if you have hives along with any of the following symptoms:� trouble swallowing � swelling of tongue � trouble speaking � wheezing or problems breathing� dizziness or loss of consciousness � swelling in or around mouth � droolingThese symptoms may be signs of anaphylactic shock. This condition can be life threatening if not treated by a healthprofessional immediately. Symptoms of anaphylactic shock may occur when hives first appear or up to a few hours later.Not a Substitute for Epinephrine. If your doctor has prescribed an epinephrine injector for “anaphylaxis” or severeallergy symptoms that could occur with your hives, never use this product as a substitute for the epinephrine injector. �

OP

EN

FO

R F

ULL

LA

BE

LIN

G�

BLACK PANT. PURPLE 306 BLUE

HIVESRelief

24HOUR

FONTS: Trade Gothic Cond. #18; Trade Gothic BoldCond. #20; Trade Gothic Bold Cond. Italics #20

Drug Facts: 9 ptHeaders 7 ptBody Text 6 ptDrug Facts (continued) 8 ptLeading 7 pt/6.5 ptBullets 5 ptFrames 1.5 ptBars 1 ptRules 0.5 pt

Page 20: Drug Facts ALLERGY 1 Tamper Evident: do not use if foil ...€¦ · Front Layer 1 of 3 3 1 9 N MYLAN NDC 0378-3635-01 100 TABLETS RM-AR3635A1 ® Cetirizine Hydrochloride Tablets 5mg

Back of Front Layer 2 2 of 3

Drug Facts (continued)If you have been prescribed an epinephrine injector, you should carry it with you at all times.Do not use� to prevent hives from any known cause such as:

� foods � insect stings � medicines � latex or rubber glovesbecause this product will not stop hives from occurring. Avoiding the cause of yourhives is the only way to prevent them. Hives can sometimes be serious. If you do notknow the cause of your hives, see your doctor for a medical exam. Your doctor may beable to help you find a cause.

� if you have ever had an allergic reaction to this product or any of its ingredients or toan antihistamine containing hydroxyzine.

Ask a doctor before use if you have� liver or kidney disease. Your doctor should determine if you need a different dose.� hives that are an unusual color, look bruised or blistered � hives that do not itch �

Drug Facts (continued)Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.When using this product� drowsiness may occur � avoid alcoholic drinks� alcohol, sedatives, and tranquilizers may increase drowsiness� be careful when driving a motor vehicle or operating machineryStop use and ask a doctor if� an allergic reaction to this product occurs. Seek medical help right away.� symptoms do not improve after 3 days of treatment� the hives have lasted more than 6 weeksIf pregnant or breast-feeding:� if breast-feeding: not recommended� if pregnant: ask a health professional before use. �

BLACK

FONTS: Trade Gothic Cond. #18; Trade Gothic BoldCond. #20; Trade Gothic Bold Cond. Italics #20

Drug Facts: 9 ptHeaders 7 ptBody Text 6 ptDrug Facts (continued) 8 ptLeading 7 pt/6.5 ptBullets 5 ptFrames 1.5 ptBars 1 ptRules 0.5 pt

Page 21: Drug Facts ALLERGY 1 Tamper Evident: do not use if foil ...€¦ · Front Layer 1 of 3 3 1 9 N MYLAN NDC 0378-3635-01 100 TABLETS RM-AR3635A1 ® Cetirizine Hydrochloride Tablets 5mg

Drug Facts (continued)Keep out of reach of children. In case of overdose, get medicalhelp or contact a Poison Control Center right away.

Directionsadults and children one 10 mg tablet once daily; do not6 years and over take more than one 10 mg tablet in

24 hours. A 5 mg product may beappropriate for less severe symptoms.

adults 65 years and over ask a doctorchildren under 6 years of age ask a doctorconsumers with liver ask a doctoror kidney disease �

Drug Facts (continued)Other information� store between 20° to 25°C (68° to 77°F)

lnactive ingredientsanhydrous lactose, colloidal silicon dioxide,hypromellose, magnesium stearate,microcrystalline cellulose, polydextrose,polyethylene glycol, sodium lauryl sulfate, titaniumdioxide, and triacetin

Questions? call 1-877-446-3679Mylan Pharmaceuticals Inc.Morgantown, WV 26505

MYLAN

NDC 0378-3637-01

100 TABLETS RM-H3637A1

®

Cetirizine HydrochlorideTablets 10 mgantihistamine

Relief ofITCHINGDue to Hives

Tamper Evident: do not use if foil seal under capis missing, open or broken

HIVESRelief

Base Layer 3 of 3

PERMANENT GLUE REMOVABLE GLUE

BLACK

FONTS: Trade Gothic Cond. #18; Trade Gothic BoldCond. #20; Trade Gothic Bold Cond. Italics #20

Drug Facts: 9 ptHeaders 7 ptBody Text 6 ptDrug Facts (continued) 8 ptLeading 7 pt/6.5 ptBullets 5 ptFrames 1.5 ptBars 1 ptRules 0.5 pt

24HOUR

Page 22: Drug Facts ALLERGY 1 Tamper Evident: do not use if foil ...€¦ · Front Layer 1 of 3 3 1 9 N MYLAN NDC 0378-3635-01 100 TABLETS RM-AR3635A1 ® Cetirizine Hydrochloride Tablets 5mg

Front Layer 1 of 3

30378-3637-05

1N

MYLAN

NDC 0378-3637-05

500 TABLETS RM-H3637B1

®

Cetirizine HydrochlorideTablets 10 mgantihistamine

Relief ofITCHINGDue to Hives

Tamper Evident: do not use if foil seal under capis missing, open or broken

Drug FactsActive Ingredient (in each tablet) PurposeCetirizine Hydrochloride 10 mg . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . AntihistamineUse relieves itching due to hives (urticaria). This product will not prevent hives or an allergic skin reaction fromoccurring.WarningsSevere Allergy Warning: Get emergency help immediately if you have hives along with any of the following symptoms:� trouble swallowing � swelling of tongue � trouble speaking � wheezing or problems breathing� dizziness or loss of consciousness � swelling in or around mouth � droolingThese symptoms may be signs of anaphylactic shock. This condition can be life threatening if not treated by a healthprofessional immediately. Symptoms of anaphylactic shock may occur when hives first appear or up to a few hours later.Not a Substitute for Epinephrine. If your doctor has prescribed an epinephrine injector for “anaphylaxis” or severeallergy symptoms that could occur with your hives, never use this product as a substitute for the epinephrine injector. �

OP

EN

FO

R F

ULL

LA

BE

LIN

G�

BLACK PANT. PURPLE 306 BLUE

HIVESRelief

24HOUR

FONTS: Trade Gothic Cond. #18; Trade Gothic BoldCond. #20; Trade Gothic Bold Cond. Italics #20

Drug Facts: 9 ptHeaders 7 ptBody Text 6 ptDrug Facts (continued) 8 ptLeading 7 pt/6.5 ptBullets 5 ptFrames 1.5 ptBars 1 ptRules 0.5 pt

Page 23: Drug Facts ALLERGY 1 Tamper Evident: do not use if foil ...€¦ · Front Layer 1 of 3 3 1 9 N MYLAN NDC 0378-3635-01 100 TABLETS RM-AR3635A1 ® Cetirizine Hydrochloride Tablets 5mg

Back of Front Layer 2 2 of 3

Drug Facts (continued)If you have been prescribed an epinephrine injector, you should carry it with you at all times.Do not use� to prevent hives from any known cause such as:

� foods � insect stings � medicines � latex or rubber glovesbecause this product will not stop hives from occurring. Avoiding the cause of yourhives is the only way to prevent them. Hives can sometimes be serious. If you do notknow the cause of your hives, see your doctor for a medical exam. Your doctor may beable to help you find a cause.

� if you have ever had an allergic reaction to this product or any of its ingredients or toan antihistamine containing hydroxyzine.

Ask a doctor before use if you have� liver or kidney disease. Your doctor should determine if you need a different dose.� hives that are an unusual color, look bruised or blistered � hives that do not itch �

Drug Facts (continued)Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.When using this product� drowsiness may occur � avoid alcoholic drinks� alcohol, sedatives, and tranquilizers may increase drowsiness� be careful when driving a motor vehicle or operating machineryStop use and ask a doctor if� an allergic reaction to this product occurs. Seek medical help right away.� symptoms do not improve after 3 days of treatment� the hives have lasted more than 6 weeksIf pregnant or breast-feeding:� if breast-feeding: not recommended� if pregnant: ask a health professional before use. �

BLACK

FONTS: Trade Gothic Cond. #18; Trade Gothic BoldCond. #20; Trade Gothic Bold Cond. Italics #20

Drug Facts: 9 ptHeaders 7 ptBody Text 6 ptDrug Facts (continued) 8 ptLeading 7 pt/6.5 ptBullets 5 ptFrames 1.5 ptBars 1 ptRules 0.5 pt

Page 24: Drug Facts ALLERGY 1 Tamper Evident: do not use if foil ...€¦ · Front Layer 1 of 3 3 1 9 N MYLAN NDC 0378-3635-01 100 TABLETS RM-AR3635A1 ® Cetirizine Hydrochloride Tablets 5mg

Drug Facts (continued)Keep out of reach of children. In case of overdose, get medicalhelp or contact a Poison Control Center right away.

Directionsadults and children one 10 mg tablet once daily; do not6 years and over take more than one 10 mg tablet in

24 hours. A 5 mg product may beappropriate for less severe symptoms.

adults 65 years and over ask a doctorchildren under 6 years of age ask a doctorconsumers with liver ask a doctoror kidney disease �

Drug Facts (continued)Other information� store between 20° to 25°C (68° to 77°F)

lnactive ingredientsanhydrous lactose, colloidal silicon dioxide,hypromellose, magnesium stearate,microcrystalline cellulose, polydextrose,polyethylene glycol, sodium lauryl sulfate, titaniumdioxide, and triacetin

Questions? call 1-877-446-3679Mylan Pharmaceuticals Inc.Morgantown, WV 26505

MYLAN

NDC 0378-3637-05

500 TABLETS RM-H3637B1

®

Cetirizine HydrochlorideTablets 10 mgantihistamine

Relief ofITCHINGDue to Hives

Tamper Evident: do not use if foil seal under capis missing, open or broken

HIVESRelief

Base Layer 3 of 3

PERMANENT GLUE REMOVABLE GLUE

BLACK

FONTS: Trade Gothic Cond. #18; Trade Gothic BoldCond. #20; Trade Gothic Bold Cond. Italics #20

Drug Facts: 9 ptHeaders 7 ptBody Text 6 ptDrug Facts (continued) 8 ptLeading 7 pt/6.5 ptBullets 5 ptFrames 1.5 ptBars 1 ptRules 0.5 pt

24HOUR