A-D · ca l 1 877 895 3665 (toll free) or 215 273 8755 (co lect) Active ingredient (in each 7.5 mL)...

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PEEL OPEN TO READ COMPLETE DIRECTIONS AND WARNINGS BEFORE PURCHASE Tamper evident s atement www.imodium.com NDC 50580 134 04 4 fl oz ( 20 ml) Controls the symptoms of diarrhea Mint Flavor Lop d HC Ant D h 1 g p 5 L ® A-D the symptoms ea Mint F Anti-Diarrheal nt Flavor Liquid Loperamide HCl Anti Diarrheal mg per 7 5 mL ® A-D Use controls symptoms of diarrhea, including Travelers’ Diarrhea Warnings Allergy alert: Do not use if you have ever had a rash or other allergic reaction to loperamide HCl Do not use if you have bloody or black stool Ask a doctor before use if you have fever mucus in he stool a history of liver disease Ask a doctor or pharmacist before use if you are taking antibiotics Drug Facts (continued) Questions or comments? ca l 1 877 895 3665 (toll free) or 215 273 8755 (co lect) Active ingredient (in each 7.5 mL) Purpose Loperamide HCl 1 mg Anti diarrheal Drug Facts Drug Facts (continued) When using this product iredness, drowsiness or dizziness may occur Be careful when driving or operating machinery Stop use and ask a doctor if symptoms get worse diarrhea lasts for more than 2 days you get abdominal swel ing or bulging These may be signs of a serious condition If pregnant or breast feeding, ask a heal h professional before use Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1 800 222 1222) Drug Facts (continued) Other information each 30 mL (6 tsp) contains: sodium 16 mg store between 20 25°C (68 77°F) tamper evident statement Inactive ingredients anhydrous cit ic acid, caramel color, D&C yellow no 10, FD&C blue no 1, flavor, glycerin, microcrysta line ce lulose and carboxymethylce lulose sodium, propylene glycol, purified water, simethicone emulsion, sodium benzoate, sucralose, titanium dioxide, xanthan gum Ac ive ingred ent made in Italy Distribu ed by: McNeil Consumer Hea thcare Division of McNE L PPC nc Fo t Wash ngton PA 19034 USA ©McNE L PPC NC 2014 Drug Facts (continued) children 9 11 years (60 95 bs) children 6 8 years (48 59 bs) 15 mL (3 tsp) a ter first loose stool; 7 5 mL (1 1 / 2 tsp) after each subsequent loose stool; but no mo e than 45 mL (9 tsp) in 24 hours 15 mL (3 tsp) a ter first loose stool; 7 5 mL (1 1 / 2 tsp) after each subsequent loose stool; but no mo e than 30 mL (6 tsp) in 24 hours children under 6 years (up to 47 lbs) ask a doctor Drug Facts (continued) Directions drink plenty of clear fluids to help prevent dehydration caused by diarrhea ind right dose on chart If possible, use weight to dose; otherwise use age shake well before using use only enclosed dosing cup spec fically designed for use w th this product Do not use any other dosing device mL = mil il ter; tsp = teaspoonful adults and children 12 years and over 30 mL (6 tsp) after the first loose stool; 15 mL (3 tsp) after each subsequent loose stool; but no more than 60 mL (12 tsp) in 24 hours PULL HERE PEEL OPEN TO READ COMPLETE DIRECTIONS AND WARNINGS BEFORE PURCHASE Tamper evident s atement O XX X 3 0045-0134-04 2 PULL HERE NDC 50580 134 04 4 fl oz ( 20 ml) Controls the symptoms of diarrhea Mint Flavor Lop d HC Ant D h 1 g p 5 L ® A-D the symptoms ea Mint F Anti-Diarrheal nt Flavor Liquid 4 fl oz ( 20 ml) 4 fl oz NN Controls the s mptoms of diarrhea Mint Flavor NN the symptoms ea Mint F Anti-Diarrheal nt Flavor Liquid LOT XXXXXXXX EXP. 3 0045-0134-04 2 PDP = 2.41 square inches .0625” Lop d HC Ant D h 1 g p 5 L L p d HC Ant D h L p d HC Ant D h L p d HC Ant D h L p d HC Ant D h ® A-D Reference ID: 3708537 Reference ID: 3718169 (b) (4)

Transcript of A-D · ca l 1 877 895 3665 (toll free) or 215 273 8755 (co lect) Active ingredient (in each 7.5 mL)...

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NDC 50580 134 04

4 f l oz( 20 ml)

Controls the symptomsof diarrhea

Mint Flavor

Lop d HC Ant D h1 g p 5 L

®

A-D

the symptomsea

Mint F

Anti-Diarrheal

nt Flavor

Liquid

Loperamide HCl Anti Diarrheal mg per 7 5 mL

®

A-D

Use controls symptoms of diarrhea, including Travelers’ Diarrhea

WarningsAllergy alert: Do not use if you have ever had a rash or other allergic reaction to loperamide HCl

Do not use if you have bloody or black stool

Ask a doctor before use if you have ■ fever ■ mucus in he stool ■ a history of liver disease

Ask a doctor or pharmacist before use if you are taking antibiotics

Drug Facts (continued)Questions or comments? ca l 1 877 895 3665 (toll free) or 215 273 8755 (co lect)

Active ingredient (in each 7.5 mL) Purpose Loperamide HCl 1 mg Anti diarrheal

Drug Facts Drug Facts (continued)When using this product iredness, drowsiness or dizziness may occur Be careful when driving or operating machinery

Stop use and ask a doctor if ■ symptoms get worse ■ diarrhea lasts for more than 2 days■ you get abdominal swel ing or bulging These may be signs of a serious condition

If pregnant or breast feeding, ask a heal h professional before useKeep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1 800 222 1222)

Drug Facts (continued)

Other information■ each 30 mL (6 tsp) contains: sodium 16 mg■ store between 20 25°C (68 77°F)■ tamper evident statement

Inactive ingredients anhydrous cit ic acid, caramel color, D&C yellow no 10, FD&C blue no 1, flavor, glycerin, microcrysta line ce lulose and carboxymethylce lulose sodium, propylene glycol, purified water, simethicone emulsion, sodium benzoate, sucralose, titanium dioxide, xanthan gum

Ac ive ingred ent made in ItalyDistribu ed by: McNeil Consumer Hea thcare Division of McNE L PPC nc Fo t Wash ngton PA 19034 USA ©McNE L PPC NC 2014

Drug Facts (continued)

children 9 11 years(60 95 bs)

children 6 8 years(48 59 bs)

15 mL (3 tsp) a ter first loose stool;7 5 mL (1 1/2 tsp) after eachsubsequent loose stool; but no mo ethan 45 mL (9 tsp) in 24 hours

15 mL (3 tsp) a ter first loose stool;7 5 mL (1 1/2 tsp) after eachsubsequent loose stool; but no mo ethan 30 mL (6 tsp) in 24 hours

children under 6 years (up to 47 lbs)

ask a doctor

Drug Facts (continued)

Directions ■ drink plenty of clear fluids to help prevent dehydration caused by diarrhea ■ ind right dose on chart If possible, use weight to dose; otherwise use age■ shake well before using■ use only enclosed dosing cup spec fically designed for use w th this product Do not use any other dosing device■ mL = mil il ter; tsp = teaspoonful

adults and children12 years and over

30 mL (6 tsp) after the first loose stool;15 mL (3 tsp) after each subsequentloose stool; but no more than60 mL (12 tsp) in 24 hours

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Reference ID: 3708537

Reference ID: 3718169

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Use controls symptoms of diarrhea, including Travelers’ Diarrhea

WarningsAllergy alert: Do not use if you have ever had a rash or other allergic reaction to loperamide HCl

Do not use if you have bloody or black stool

Ask a doctor before use if you have ■ fever ■ mucus in he stool ■ a history of liver disease

Ask a doctor or pharmacist before use if you are taking antibiotics

Drug Facts (continued)Questions or comments? ca l 1 877 895 3665 (to l free) or 215 273 8755 (co lect)

Active ingredient (in each 7.5 mL) Purpose Loperamide HCl 1 mg Anti diarrheal

Drug Facts Drug Facts (continued)When using this product iredness, drowsiness or dizziness may occur Be careful when driving or operating machinery

Stop use and ask a doctor if ■ symptoms get worse ■ diarrhea lasts for more than 2 days■ you get abdominal swel ing or bulging These may be signs of a serious condition

If pregnant or breast feeding, ask a heal h professional before useKeep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1 800 222 1222)

Drug Facts (continued)

Other information■ each 30 mL (6 tsp) contains: sodium 16 mg■ store between 20 25°C (68 77°F)■ tamper evident statement

Inactive ingredients anhydrous cit ic acid, caramel color, D&C yellow no 10, FD&C blue no 1, flavor, glycerin, microcrysta line ce lulose and carboxymethylce lulose sodium, propylene glycol, purified water, simethicone emulsion, sodium benzoate, sucralose, titanium dioxide, xanthan gum

Ac ive ingred ent made in ItalyDistribu ed by: McNeil Consumer Hea thca e Division of McNE L PPC nc Fort Wash ngton PA 19034 USA ©McNE L PPC NC 2014

Drug Facts (continued)

children 9 11 years(60 95 bs)

children 6 8 years(48 59 bs)

15 mL (3 tsp) a ter first loose stool;7 5 mL (1 1/2 tsp) after eachsubsequent loose stool; but no morethan 45 mL (9 tsp) in 24 hours

15 mL (3 tsp) a ter first loose stool;7 5 mL (1 1/2 tsp) after eachsubsequent loose stool; but no morethan 30 mL (6 tsp) in 24 hours

children under 6 years (up to 47 lbs)

ask a doctor

Drug Facts (continued)

Directions ■ drink plenty of clear fluids to help prevent dehydration caused by diarrhea ■ ind right dose on chart If possible, use weight to dose; otherwise use age■ shake well before using■ use only enclosed dosing cup spec fically designed for use w th this product Do not use any other dosing device■ mL = mil il ter; tsp = teaspoonful

adults and children12 years and over

30 mL (6 tsp) after the first loose stool;15 mL (3 tsp) after each subsequentloose stool; but no more than60 mL (12 tsp) in 24 hours

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Reference ID: 3708537

Reference ID: 3718169

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Loperamide HCl, Anti Diarrheal1 mg per 7.5 mL

NDC 50580 134 08

Controls the symptomso diarrhea

Mint Flavor

Anti-Diarrheal

t Flavor

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Liquid

8 l oz(240 ml)

Lop d HC Ant D h1 g p 5 L

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PULLHERE

If pregnant or breast feeding, ask a hea th professional befo e useKeep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center ight away (1 800 222 1222)

Di ections ■ drink plenty of clear fluids to help prevent dehydration

caused by diarrhea ■ find right dose on chart f poss ble, use weight to dose;

otherwise use age ■ shake we l before using ■ only use enclosed dosing cup spec fica ly designed for use

wi h this product Do not use any o her dosing device

WarningsAllergy alert: Do not use f you have ever had a rash or o her allergic reac ion to loperam de HCl

Do not use f you have bloody or black stoolAsk a doctor before use if you have■ fever ■ mucus in he stool ■ a history of iver disease

Active ing edient (in each 7.5 mL) PurposeLope am de HCl 1 mg Anti diarrheal

Drug Facts

Usecontrols symptoms of diar hea, including Travelers’ Diarrhea

Ask a doctor or pharmacist before use if you are taking ant biotics

Drug Facts (continued)

When using his p oduct tiredness, drowsiness or dizziness may occur Be careful when driving or operating machinery

■ store between 20 25 C (68 77 F)■ tamper evident statement

Other info mation ■ each 30 mL (6 tsp) contains: sodium 16 mg

Inacti e ing edients anhydrous c tric ac d, caramel color, D&C yellow no 10, FD&C blue no 1, flavor, glycerin, microcrysta line cellulose and ca boxyme hylcellulose sodium, propylene glycol, puri ied water, sime hicone emulsion, sodium benzoate, sucralose, t tanium dioxide, xanthan gum

Drug Facts (continued)Drug Facts ( ontinued)

Q estions or c mments? ca l 1 877 895 3665 (to l free) or 215 273 8755 (co lec )

adults and ch ldren 12 years and overch ldren 9 11 yea s(60 95 lbs) ch ldren 6 8 years(48 59 lbs)

30 mL (6 tsp) after the first loose stool; 15 mL (3 tsp) after each subsequent loose stool; but no mo e than 60 mL (12 tsp) in 24 hours15 mL (3 tsp) after i st loose stool; 7 5 mL (1 1/2 tsp) after each subsequent loose stool; but no more than 45 mL (9 tsp) in 24 hours15 mL (3 tsp) after first loose stool; 7 5 mL (1 1/2 tsp) after each subsequent loose stool; but no more han 30 mL (6 tsp) in 24 hou s

ch ldren under 6 years(up to 47 lbs)

ask a doctor

Act ve ingred ent made in talyD s ributed by: McNeil Consumer Heal hcare D v sion of McNEIL PPC Inc Fort Washington PA 19034 USA ©McNEIL PPC INC 2014

Stop use a d ask a doctor if ■ symptoms get o se ■ d a hea asts fo more than 2 days ■ you get abdom na swel ng or bu g ng. These may be

s gns of a se ous ond t on.

■ mL m l i ter; tsp teaspoonful

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Act ve ing edient made in talyDis ributed by: McNeil Consumer Heal hcare Div s on of McNE L PPC nc Fort Washing on PA 19034 USA ©McNE L PPC NC 2014

Loperamide HCl, Anti Diarrheal1 mg per 7.5 mL

NDC 50580 134 08

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Reference ID: 3708537

Reference ID: 3718169

(b) (4)