Pfizer, Madison, NJ 07940 USA © 2017 Pfizer Inc. · drug facts text defined • drug facts title...

PRODUCTION (NOT COLOR ACCURATE)

DRUG FACTSLABELING AREA

128

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Silver Foil Stamp

For most recent product information, visit www.advil.comQuestions or comments? Call weekdays from 9 AM to 5 PM ESTtoll free at 1-800-88-ADVIL

MULTI-SYMPTOMCOLD & FLU

CoatedTablets

MULTI-SYMPTOMCOLD & FLUMULTI-SYMPTOMCOLD & FLU

10

Pfize

r, Mad

ison,

NJ 07

940 U

SA

© 20

17 P

fizer

Inc.Product inside sealed in plastic blister with foil backing.

Do Not Use if plastic blister or foil barrier is broken.

MU

LTI-

SYM

PTO

MCO

LD &

FLU

CoatedTablets

AdvilCF

HeadacheFeverBody AchesSinus Pressure

Nasal CongestionRunny NoseSneezingNasal Swelling

u o e 200 mg Pa Re ieve / eve Re ucer (NSAID)P e y ep e CI 10 g asa De o ges a tC o phe rami e Malea e 4 g An ih s a e


ONETABLETDOSE!

10

NEW!NEW!

PAA075544.FDA02

30573 0190 10

6

FPO 128 Code FPO

128

Code

128

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128

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-201

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Reference ID: 4090685

(b) (4)



128

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AR

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Cod

e 12

8 =

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128

HD

CO

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8 =

049

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Silver Foil Stamp

For most recent product information, visit www.advil.comQuestions or comments? Call weekdays from 9 AM to 5 PM ESTtoll free at 1-800-88-ADVIL


CoatedTablets


20

Pfize

r, Mad

ison,

NJ 07

940 U

SA

© 20

17 P

fizer

Inc.Product inside sealed in plastic blister with foil backing.

Do Not Use if plastic blister or foil barrier is broken.

MU

LTI-

SYM

PTO

MCO

LD &

FLU

CoatedTablets

AdvilCF



u o e 200 mg Pa Re ieve / eve Re ucer (NSAID)P e y ep e CI 10 g asa De o ges a tC o phe rami e Malea e 4 g An ih s a e


ONETABLETDOSE!

20

NEW!NEW!

PAA075545.FDA02

30573 0190 20

6

FPO 128 Code FPO

128

Code

128

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(b) (4)

DRUG FACTS TEXT DEFINED

• DRUG FACTS TITLE

• DRUG FACTS CONTINUED

• HEADINGS

• SUBHEADINGS/BODY TEXT

• LEADING

• # OF CHARACTERS PER INCH

• BULLETS

• SPACE BEFORE BULLET

• BARLINES, HAIRLINES

• SPACE BETWEEN HAIRLINES AND BOX END

TYPE SIZE

9 pt

8 pt

8 pt

6 pt

6.5 pt

<39

5 pt

2 ems

1.5 pt, .5 pt

2 spaces


LIFT HERE

for More Drug Facts

Drug FactsActive ingredients (in each tablet) PurposesChlorpheniramine maleate 4 mg ......................... AntihistamineIbuprofen 200 mg (NSAID)* ............. Pain reliever/Fever reducerPhenylephrine HCl 10 mg........................... Nasal decongestant*nonsteroidal anti-in�ammatory drug

Uses� temporarily relieves these symptoms associated with the

common cold or �u: � headache � fever� minor body aches and pains� nasal congestion � runny nose� sinus pressure � sneezing

� reduces swelling of the nasal passages� temporarily restores freer breathing through the nose

WarningsAllergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:� hives � facial swelling � asthma (wheezing)� shock � skin reddening � rash � blistersIf an allergic reaction occurs, stop use and seek medical help right away.

READ AND KEEP CARTON FOR COMPLETE WARNINGS AND INFORMATION

Drug Facts (continued)Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: � are age 60 or older� have had stomach ulcers or bleeding problems� take a blood thinning (anticoagulant) or steroid drug� take other drugs containing prescription or

nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]

� have 3 or more alcoholic drinks every day while using this product

� take more or for a longer time than directedHeart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.

Drug Facts (continued)Do not use� in children under 12 years of age� if you have ever had an allergic reaction to any other

pain reliever/fever reducer� right before or after heart surgery� if you are now taking a prescription monoamine

oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if� you have a breathing problem such as emphysema

or chronic bronchitis� stomach bleeding warning applies to you� you have problems or serious side effects from

taking pain relievers or fever reducers� you have a history of stomach problems, such

as heartburn� you have high blood pressure, heart disease, liver

cirrhosis, kidney disease, asthma, thyroid disease, diabetes, glaucoma, have trouble urinating due to an enlarged prostate gland, or had a stroke

� you are taking a diuretic

Drug Facts (continued)Ask a doctor or pharmacist before use if you are� under a doctor’s care for any serious condition� taking sedatives or tranquilizers� taking any other product that contains

phenylephrine, chlorpheniramine or any other nasal decongestant or antihistamine

� taking aspirin for heart attack or stroke, because ibuprofen may decrease this bene�t of aspirin

� taking any other drugWhen using this product� take with food or milk if stomach upset occurs� avoid alcoholic drinks� be careful when driving a motor vehicle or

operating machinery� drowsiness may occur� alcohol, sedatives, and tranquilizers may increase

drowsiness� may cause excitability especially in childrenStop use and ask a doctor if� you experience any of the following signs of

stomach bleeding:� feel faint� vomit blood� have bloody or black stools� have stomach pain that does not get better

Drug Facts (continued)� you have symptoms of heart problems

or stroke:� chest pain� trouble breathing� weakness in one part or side of body� slurred speech� leg swelling

� pain gets worse or lasts more than 7 days� fever gets worse or lasts more than 3 days� nasal congestion lasts for more than 7 days� redness or swelling is present in the

painful area� you get nervous, dizzy, or sleepless� symptoms continue or get worse� any new symptoms appearIf pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless de�nitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Drug Facts (continued)Directions� do not take more than directed� adults and children 12 years of age and over:

� take 1 tablet every 4 hours while symptoms persist� do not take more than 6 tablets in any 24-hour

period, unless directed by a doctor� children under 12 years of age: do not use

Other information� read all warnings and directions before use.

Keep carton.� store at 20-25°C (68-77°F)� avoid excessive heat above 40°C (104°F)

Inactive ingredients acesulfame potassium, arti�cial �avors, carnauba wax, colloidal silicon dioxide, corn starch, croscarmellose sodium, glycerin, glyceryl behenate, hypromellose, lactic acid, lecithin, maltodextrin, medium-chain triglycerides, microcrystalline cellulose, pharmaceutical ink, polydextrose, polyvinyl alcohol, pregelatinized starch, propyl gallate, silicon dioxide, sucralose, synthetic iron oxide, talc, titanium dioxide, triacetin, xanthan gum

Questions or comments? Call weekdays from 9 AM to 5 PM EST toll free at 1-800-88-ADVIL

PAA085890.FDA02

PANEL1

PANEL2

BASEPANEL

HINGE AREA

HINGE AREA

3/16" x 3/16" DATA MATRIX CODE (ECC200), PRINTED IN BLACK OR DARK BLUE ON UNPRINTED WHITE BACKGROUNDDATA MATRIX CODE = 085890

NOTE: BLACK RULE MUST PRINT.

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-201

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• DRUG FACTS TITLE

• DRUG FACTS CONTINUED

• HEADINGS


• LEADING

• # OF CHARACTERS PER INCH

• BULLETS


• BARLINES, HAIRLINES

• SPACE BETWEEN HAIRLINES AND BOX END

TYPE SIZE

9 pt

8 pt

8 pt

6 pt

6.5 pt

<39

5 pt

2 ems

1.5 pt, .5 pt

2 spaces


50 Packets of 1Coated Tablet

ONETABLETDOSE!



Ibuprofen 200 mg Pain Reliever/Fever Reducer (NSAID)Phenylephrine HCI 10 mg Nasal DecongestantChlorpheniramine Maleate 4 mg Antihistamine



ONETABLETDOSE!






ONETABLETDOSE!

HeadacheFeverBody AchesSinus PressureNasal CongestionRunny NoseSneezingNasal Swelling




ONETABLETDOSE!



HeadacheFeverBody AchesSinus PressureNasal CongestionRunny NoseSneezingNasal Swelling

AdvilCF Advil

CFAdvil

CF

AdvilCF

NEW!NEW!

N !NEW!

NENEW! N W!NEW!

PAA0

6779

9.FD

A04

3 0573 0190 01 5

128

CODE

FPO

0677

99

P�zer, Madison, NJ 07940 USA © 2017 P�zer Inc. For most recent product information, visit www.advil.com Do Not Use if pouch is broken or torn

Drug FactsActive ingredients (in each tablet) PurposesChlorpheniramine maleate 4 mg...........................................AntihistamineIbuprofen 200 mg (NSAID)*...............................Pain reliever/Fever reducerPhenylephrine HCl 10 mg.............................................Nasal decongestant*nonsteroidal anti-in�ammatory drug

Uses� temporarily relieves these symptoms associated with the common cold

or �u: � headache� fever� minor body aches and pains� nasal congestion� runny nose� sinus pressure� sneezing

� reduces swelling of the nasal passages� temporarily restores freer breathing through the nose

WarningsAllergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:� hives � facial swelling � asthma (wheezing)� shock � skin reddening � rash � blistersIf an allergic reaction occurs, stop use and seek medical help right away.Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:� are age 60 or older � have had stomach ulcers or bleeding problems� take a blood thinning (anticoagulant) or steroid drug� take other drugs containing prescription or nonprescription NSAIDs

[aspirin, ibuprofen, naproxen, or others]� have 3 or more alcoholic drinks every day while using this product� take more or for a longer time than directedHeart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.Do not use� in children under 12 years of age� if you have ever had an allergic reaction to any other pain reliever/

fever reducer� right before or after heart surgery� if you are now taking a prescription monoamine oxidase inhibitor (MAOI)

(certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if� you have a breathing problem such as emphysema or chronic bronchitis� stomach bleeding warning applies to you� you have problems or serious side effects from taking pain relievers or

fever reducers� you have a history of stomach problems, such as heartburn� you have high blood pressure, heart disease, liver cirrhosis, kidney

disease, asthma, thyroid disease, diabetes, glaucoma, have trouble urinating due to an enlarged prostate gland, or had a stroke

� you are taking a diuretic

Drug Facts (continued)Ask a doctor or pharmacist before use if you are� under a doctor’s care for any serious condition� taking sedatives or tranquilizers� taking any other product that contains phenylephrine, chlorpheniramine or any

other nasal decongestant or antihistamine� taking aspirin for heart attack or stroke, because ibuprofen may decrease this

bene�t of aspirin� taking any other drugWhen using this product� take with food or milk if stomach upset occurs� avoid alcoholic drinks� be careful when driving a motor vehicle or operating machinery� drowsiness may occur� alcohol, sedatives, and tranquilizers may increase drowsiness� may cause excitability especially in childrenStop use and ask a doctor if� you experience any of the following signs of stomach bleeding:

� feel faint � vomit blood � have bloody or black stools� have stomach pain that does not get better

� you have symptoms of heart problems or stroke:� chest pain � trouble breathing � weakness in one part or side of body� slurred speech � leg swelling

� pain gets worse or lasts more than 7 days� fever gets worse or lasts more than 3 days� nasal congestion lasts for more than 7 days� redness or swelling is present in the painful area� you get nervous, dizzy, or sleepless� symptoms continue or get worse� any new symptoms appearIf pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless de�nitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions� do not take more than directed� adults and children 12 years of age and over:

� take 1 tablet every 4 hours while symptoms persist� do not take more than 6 tablets in any 24-hour period, unless directed by

a doctor� children under 12 years of age: do not use

Other information� read all warnings and directions before use.� store at 20-25°C (68-77°F) � avoid excessive heat above 40°C (104°F)

Inactive ingredients acesulfame potassium, arti�cial �avors, carnauba wax, colloidal silicon dioxide, corn starch, croscarmellose sodium, glycerin, glyceryl behenate, hypromellose, lactic acid, lecithin, maltodextrin, medium-chain triglycerides, microcrystalline cellulose, pharmaceutical ink, polydextrose, polyvinyl alcohol, pregelatinized starch, propyl gallate, silicon dioxide, sucralose, synthetic iron oxide, talc, titanium dioxide, triacetin, xanthan gum

Questions or comments? Call weekdays from 9 AM to 5 PM EST toll free at 1-800-88-ADVIL

128

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(b) (4)


• HEADINGS


• LEADING

• BULLETS


• WARNING BOX LINE, HAIRLINES

TYPE SIZE

4.5 pt

4.5 pt

4.5 pt

N/A

N/A

N/A


TO OPEN: FOLD BACK ON DOTTED LNE.TEAR ON ARROW

OR USE SCISSORS.Do Not Use f pouch is broken or torn.

Uses temporarily relieves these symptoms associated with the common cold or �u: headache, fever, minor body aches and pains, nasal congestion, runny nose, sinus pressure, sneezing; reduces swelling of the nasal passages; temporarily restores freer breathing through the nose Warnings Allergy alert: Ibuprofen

may cause a severe allergic reaction, especially in people a lergic to aspirin. Symptoms may include: hives, facial swel ing, asthma (wheezing), shock, skin reddening, rash, blisters. If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains an NSA D, which may cause severe stomach bleeding. The chance is higher if you: are age 60 or older, have had stomach ulcersor bleeding problems, take a blood thinning (anticoagulant) or steroid drug, take other drugs containing prescription or nonprescription NSA Ds [aspirin, ibuprofen, naproxen, or others], have 3 or more alcoholic drinks every day wh le using this product, take more or for a longer time than directed. Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed. Do not use in children under 12 years of age, f you have ever had an a lergic reaction to any other pain reliever/fever reducer, right before or after heart surgery, f you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emot onal conditions, or Parkinson's disease), or for2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have a breathing problem

such as emphysema or chronic bronchitis; stomach bleeding warning app ies to you; you have problems or serious side effects from taking pain re ievers or fever reducers; you have a history of stomach

PAA067797.FDA02


*nonsteroidal anti-in�ammatory drug

Ibuprofen 200 mg (NSAID)*...Pain Reliever/Fever ReducerPhenylephrine HCI 10 mg .................. Nasal DecongestantChlorpheniramine Maleate 4 mg ................. Antihistamine1 Tablet

FRONT

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• HEADINGS


• LEADING

• BULLETS



TYPE SIZE

4.5 pt

4.5 pt

4.5 pt

N/A

N/A

N/A


problems, such as heartburn; you have h gh blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, thyroid disease, diabetes, glaucoma, have trouble urinating due to an

enlarged prostate gland, or had a stroke; you are taking a diuretic. Ask a doctor or pharmacist before use if you are under a doctor’s care for any serious cond tion, taking sedatives or tranquilizers, taking any

other product that contains phenylephrine, chlorpheniramine or any other nasal decongestant or antihistamine, taking aspirin for heart attack or stroke, because ibuprofen may decrease this bene�t of aspirin or taking any other

drug. When using this product take with food or m lk f stomach upset occurs, avoid alcoho ic drinks, be carefulwhen driving a motor vehicle or operating machinery, drowsiness may occur, alcohol, sedatives, and tranqui izers may ncrease drowsiness, may cause exc tab lity especially in children. Stop use and ask a doctor if you experience any of he following signs of stomach bleeding: feel faint, vomit blood, have bloody or black stools or have stomach pain that

does not get better; you have symptoms of heart problems or stroke: chest pain, trouble breathing, weakness in one part or side of body, slurred speech, or leg swelling; pain gets worse or lasts more han 7 days; fever gets worse or lasts more than 3 days; nasal congestion lasts for more than 7 days; redness or swel ing is present in the painful area; you get nervous, dizzy, or sleepless; symptoms continue or get worse; any new symptoms appear. If pregnant or breast-feeding, ask a health professional before use. t is especia ly important not to use buprofen during the last 3 months of pregnancy unless de�nitely directed to do so by a doctor because t may cause problems in he unborn hild or complications during delivery. Keep out of reach of ch ldren. In case of overdose, get medical help or contact

a Poison Control Center right away. Directions Do not take more than directed. Adu ts and ch ldren 12 years of age nd over: take 1 tablet every 4 hours while symptoms persist. Do not take more than 6 tablets in any 24-hour period nless directed by a doctor. Children under 12 years of age: do not use. Other information Read all warnings and irections before use. Store at 20-25°C (68-77°F). Avoid excessive heat above 40°C (104°F). Inactive ingredients

acesu fame potassium, art �cial �avors, carnauba wax, col oida silicon dioxide, corn starch, croscarmellose sodium, glycerin, glyceryl behenate, hyprome lose, lactic acid, lec thin, maltodextrin, medium-chain triglycerides, microcrystalline cellulose, pharmaceutical ink, polydextrose, polyvinyl alcohol, pregelatinized starch, propyl gallate, silicon dioxide,

sucralose, syn hetic iron oxide, talc, titanium dioxide, triacetin, xanthan gum � to l free at 1-800-88-ADVILP�zer, Madison, NJ 07940 USA PAA067798.FDA03

25 mm

BACK

AREA FOR LOT AND EXPTO BE PRINTED IN DARK COLOR

26 mm x 5.5 mm

SEAL AREA FOR LOT & EXP25 mm x 4.5 mm

25 mm26 mm

5.5 mm 4.5 mm

AREA FOR LOT AND EXPTO BE PRINTED IN DARK COLOR

26 mm x 5.5 mm(OUTER OVAL)

SEAL AREA FOR LOT & EXP25 mm x 4.5 mm(INNER OVAL)

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• HEADINGS


• LEADING

• BULLETS



TYPE SIZE

N/A

5.5 pt

6 pt

4.5 pt

2 ems

N/A


Ibuprofen 200 mgPhenylephrine HCl 10 mgChlorpheniramine Maleate 4 mgSee warnings before use.Pfizer, Madison, NJ 07940 USA

®

Multi-Symptom Cold & FluIbuprofen 200 mgPhenylephrine HCl 10 mgChlorpheniramine Maleate 4 mgSee warnings before use.Pfizer, Madison, NJ 07940 USA

®

Multi-Symptom Cold & Flu


®



®



®



®



®



®



®


buprofen 200 mgPhenylephrine HCl 10 mgChlorpheniramine Maleate 4 mgSee warnings before use.Pfizer, Madison, NJ 07940 USA

®


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PAA0

6792

9.FDA

02

PEEL & PUSH

PEEL & PUSH PEEL & PUSH

PEEL & PUSH

PEEL & PUSH


PEEL & PUSH

PEEL & PUSH


PEEL & PUSHAREA FOR EXP. & LOT AREA FOR EXP. & LOT

AREA FOR EXP. & LOT AREA FOR EXP. & LOT


AREA FOR EXP. & LOTAREA FOR EXP. & LOT


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---------------------------------------------------------------------------------------------------------This is a representation of an electronic record that was signedelectronically and this page is the manifestation of the electronicsignature.---------------------------------------------------------------------------------------------------------/s/----------------------------------------------------

THERESA M MICHELE04/28/2017


Pfizer, Madison, NJ 07940 USA © 2017 Pfizer Inc. · drug facts text defined • drug facts title...

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