Do Not Use if plastic blister or foil barrier is … · Silver Foil Stamp For most recent product information, visit Questions or comments? Call weekdays from 9 AM to 5 PM EST

DRUG FACTSLABELING AREA

Silver Foil Stamp

Job Information Color Legend

PRODUCTION (NOT COLOR ACCURATE)

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

SINUSCONGESTION & PAIN

CoatedTablets


Product inside sealed in plastic blister with foil backing.Do Not Use if plastic blister or foil barrier is broken.

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b pro e 200 mg P n Re ever Feve ed ce (NSAID)P e y e i e HCI 10 g Nasa eco ges an

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Reference ID: 4074759

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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


10CoatedTablets


Product inside sealed in plastic blister with foil backing.Do Not Use if plastic blister or foil barrier is broken.

Pfize

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10 CoatedTablets

ONETABLETDOSE!

NON DROWSYNON-DROWSY

bupro en 2 0 g Pain Re ever/Feve Re uce (NSAID)P e y e i e CI 0 mg asa eco ges an

Nasal CongestionSinus PressureNasal Swelling

HeadacheFeverBody Aches

PAA060866

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128

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3 0573 0199 11 7


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10 TABLETSFREE

D000052196

10 TABLETSFREEFREEFREEFREE

10 TABLETS10 TABL S10 TABLETS

Pfizer Consumer HealthcareAdvil Sinus Congestion & Pain 20+10CT Bonus Pack Label D000052196

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-201

6 04

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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 Purposes(in each tablet)Ibuprofen 200 mg (NSAID)* ....................Pain reliever/fever reducerPhenylephrine HCl 10 mg...................................Nasal decongestant*nonsteroidal anti-inflammatory drug

Uses� temporarily relieves these symptoms associated with the common

cold or flu:� headache� fever� sinus pressure� nasal congestion� minor body aches and pains

� 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.

READ AND KEEP CARTON FOR COMPLETE WARNINGS AND INFORMATION

PAA080421

Drug Facts (continued)Symptoms may include:� hives � facial swelling� asthma (wheezing) � shock� skin reddening � rash� blistersIf an allergic reaction occurs, stop use and seek medicalhelp 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 directed

Drug Facts (continued)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 because this product

contains too much medication for children under this 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� 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, 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 any other product that contains phenylephrine

or any other nasal decongestant� taking aspirin for heart attack or stroke, because

ibuprofen may decrease this benefit of aspirin� taking any other drug

When using this product� take with food or milk if stomach upset occurs

Stop 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� symptoms continue or get worse

Drug Facts (continued)� redness or swelling is present in the painful area� you get nervous, dizzy, or sleepless� any new symptoms appear

If 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 definitely 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 use more than 6 tablets in any 24-hour period

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

product contains too much medication for children under this age

Other information� store at 20-25°C (68-77°F). Avoid excessive heat above

40°C (104°F).� read all warnings and directions before use.

Keep carton.

Drug Facts (continued)Inactive ingredients acesulfame potassium, artificial flavor, carnauba wax, colloidal silicon dioxide, corn starch, croscarmellose sodium, glycerin, hypromellose, lactic acid, lecithin, maltodextrin, medium-chain triglycerides, microcrystalline cellulose, pharmaceutical ink, polydextrose, polyvinyl alcohol, pregelatinized starch, propyl gallate, sodium lauryl sulfate, stearic acid, 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

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=080421

NOTE: BLACK RULE MUST PRINT.

0901

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28-

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-201

6 21

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(b) (4)


• 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

N/A

8 pt

6 pt

6.5 pt

<39

5 pt

2 ems

1.5 pt, .5 pt

2 spaces


NON-DROWSYNON-DROWSY

Ibuprofen 200 mg Pain Reliever/Fever Reducer (NSAID)Phenylephrine HCI 10 mg Nasal Decongestant

Nasal Congestion Headache Sinus Pressure Fever Nasal Swelling Body Aches 50 Packets of 1

Coated Tablet


ONETABLETDOSE!

50 Packets of 1Coated Tablet




Nasal Congestion Headache Sinus Pressure Fever Nasal Swelling Body Aches

ONETABLETDOSE!





Nasal Congestion Sinus Pressure Nasal SwellingHeadache FeverBody Aches


ONETABLETDOSE!

Nasal Congestion Sinus Pressure Nasal SwellingHeadache FeverBody Aches



ONETABLETDOSE!


PAA0

8043

3

3 0573 0199 01 8

128

CODE

FPO

0804

33

Pfizer, Madison, NJ 07940 USA © 2016 Pfizer Inc.For most recent product information, visit www.advil.comDo Not Use if pouch is broken or torn

Drug FactsActive ingredients (in each tablet) PurposesIbuprofen 200 mg (NSAID)*..........................................Pain reliever/fever reducerPhenylephrine HCl 10 mg........................................................Nasal decongestant*nonsteroidal anti-inflammatory drug

Uses� temporarily relieves these symptoms associated with the common cold or flu:

� headache � fever � sinus pressure � nasal congestion � minor body aches and pains

� 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 because this product contains too much

medication for children under this 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� 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, 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 any other product that contains phenylephrine or any other

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

benefit of aspirin� taking any other drug

When using this product� take with food or milk if stomach upset occurs

Stop 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� symptoms continue or get worse� redness or swelling is present in the painful area� you get nervous, dizzy, or sleepless� any new symptoms appear

If 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 definitely 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 use more than 6 tablets in any 24-hour period unless directed by a doctor

� children under 12 years of age: do not use because this product contains too much medication for children under this age

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

Inactive ingredientsacesulfame potassium, artificial flavor, carnauba wax, colloidal silicon dioxide, corn starch, croscarmellose sodium, glycerin, hypromellose, lactic acid, lecithin, maltodextrin, medium-chain triglycerides, microcrystalline cellulose, pharmaceutical ink, polydextrose, polyvinyl alcohol, pregelatinized starch, propyl gallate, sodium lauryl sulfate, stearic acid, 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

LAS

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Sep

-201

6 21

:25


(b) (4)


• HEADINGS


• LEADING

• BULLETS


• WARNING BOX LINE, HAIRLINES

TYPE SIZE

N/A

5.5 pt

6 pt

4.5 pt

2 ems

N/A



Ibuprofen 200 mg / Phenylephrine HCl 10 mgSee warnings before use.Pfizer, Madison, NJ 07940 USA

®

Sinus Congestion & PainIbuprofen 200 mg / Phenylephrine HCl 10 mgSee warnings before use.Pfizer, Madison, NJ 07940 USA

®

Sinus Congestion & Pain


®


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PAA0

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8

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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-201

6 04

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• HEADINGS


• LEADING

• BULLETS



TYPE SIZE

4.5 pt

4.5 pt

4.5 pt

N/A

N/A

N/A



128 Code = 080434

S C P

p 0 g y p 0 F )

* y

Uses temporarily relieves these symptoms associated with the common cold or �u: headache, fever, sinus pressure, nasal congestion, minor body aches and pains; reduces swelling of nasal passages; temporarily restores freer brea hing through the nose. WarningsAllergy alert: buprofen may cause a severe a lergic reaction, especially in people a lergic to aspirin. Symptoms may include: hives, facial swe ling, 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 NSAID, which may cause severe stomach bleeding. The chance is higher f 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 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 f you use more than directed or for longer than directed. Do not use in ch ldren under 12 years of age because this product contains too much medication for children under this age, if you have ever had an allergic reaction to any other pain re iever/fever reducer, right before or after heart surgery, if you are now taking a prescription monoamine oxidase inh bitor (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 stomach bleeding warning applies to you;

TO OPEN: FOLD BACK ON DOTTED LINE.TEAR ON ARROW OR USE SCISSORS.

Do Not Use if pouch is broken or torn.

PAA0

8043

4

FRONT

0901

77e1

89bc

c6e3

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On:

28-

Sep

-201

6 21

:19


(b) (4)


• HEADINGS


• LEADING

• BULLETS



TYPE SIZE

4.5 pt

4.5 pt

4.5 pt

N/A

N/A

N/A



128 Code = 080435

you have problems or serious side effects from taking pain re ievers 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, 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 condition, taking any other product that contains phenylephrine or any other nasal decongestant, taking aspirin for heart attack or stroke, because ibuprofen may decrease his bene�t of aspirin or taking any other drug. When using this product take w th food or milk if stomach upset occurs. Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint, vom t 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, leg swe ling; 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; symptoms continue or get worse; redness or swel ing is present in the painful area; you get nervous, dizzy, or sleepless; any new symptoms appear. If pregnant or breast-feeding, ask a hea th 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 use more than 6 tablets in any 24-hour period unless directed by a doctor. Children under 12 years of age: do not use because this product contains too much medication for children under this age. Other information Store at 20-25 C (68-77°F). Avoid excessive heat above 40°C (104°F). Read a l warnings and directions before use. Inactive ingredients acesulfame potassium, arti�cial �avor, carnauba wax, colloidal silicon dioxide, corn starch, croscarme lose sodium, glycerin, hypromellose, lactic acid, lecithin, maltodextrin, medium-chain triglycerides, microcrystalline cellulose, pharmaceutical ink, polydextrose, polyvinyl alcohol, pregela inized starch, propyl gallate, sodium lauryl sulfate, stearic acid, sucralose, synthetic iron oxide, talc, titanium dioxide, triace in, xanthan gum � toll free at 1-800-88-ADVIL For most recent product information, visit

www.advil.com P�zer, Madison, NJ 07940 USA © 2016 P�zer Inc.

PAA0

8043

5

BACK

AR

EA

FO

R LO

T A

ND

EX

PT

O B

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RIN

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DA

RK

CO

LOR

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

FOR BACK ONLY

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)

0901

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(b) (4)

PFIZERASSEMBLY INSTRUCTIONS

ADVIL SINUS CONG & PAIN 20 CT - W/ $1 IRC

Component: D000051586019911A

D000051586

0901

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9886

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-201

6 04

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(b) (4)

(b) (4)

PFIZERASSEMBLY INSTRUCTIONS

ADVIL SINUS CONG & PAIN 20 CT - ONE PILL DOSAGE LABEL (OPEN STOCK)

Component: D000051585019921A

D000051585

0901

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9889

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-201

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(b) (4)

(b) (4)

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

VALERIE S PRATT03/24/2017


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Do Not Use if plastic blister or foil barrier is … · Silver Foil Stamp For most recent product information, visit Questions or comments? Call weekdays from 9 AM to 5 PM EST