ADVIL ALLERGY SINUS- chlorpheniramine maleate, ibuprofen, pseudoephedrine hcl tablet, coated 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC

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Drug Facts

ACTIVE INGREDIENTS (IN EACH CAPLET)

Chlorpheniramine maleate 2 mg

Ibuprofen 200 mg (NSAID)*

Pseudoephedrine HCl 30 mg

*nonsteroidal anti-inflammatory drug

PURPOSES

Antihistamine

Pain reliever/fever reducer

Nasal decongestant

USES

temporarily relieves these symptoms associated with hay fever or other upper respiratory allergies, and the common cold:

runny nose
itchy, watery eyes
itching of the nose or throat
sneezing
nasal congestion
sinus pressure
headache
minor aches and pains
fever

WARNINGS

Allergy 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
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 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

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
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, 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 sedatives or tranquilizers
taking any other product that contains pseudoephedrine, chlorpheniramine or any other nasal decongestant or antihistamine
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
avoid alcoholic drinks
be careful when driving a motor vehicle or operating machinery
drowsiness may occur
alcohol, sedatives, and tranquilizers may increase drowsiness

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
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 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
the smallest effective dose should be used
adults: take 1 caplet every 4-6 hours while symptoms persist.
do not take more than 6 caplets 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

carnauba wax, colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C red no. 40 aluminum lake, FD&C yellow no. 6 aluminum lake, glyceryl behenate, hypromellose, microcrystalline cellulose, pharmaceutical ink, polydextrose, polyethylene glycol, pregelatinized starch, silicon dioxide, titanium dioxide

QUESTIONS OR COMMENTS?

Call weekdays from 9 AM to 5 PM EST at 1-800-88-ADVIL

For most recent product information, visit www.advil.com

PRINCIPAL DISPLAY PANEL

Advil®

ALLERGY SINUS

Ibuprofen 200 mg ➤ Pain Reliever/Fever Reducer (NSAID)
Pseudoephedrine HCl 30 mg ➤ Nasal Decongestant
Chlorpheniramine Maleate 2 mg ➤ Antihistamine

Relieves Runny Nose, Nasal Congestion, Sneezing,
Itchy, Watery Eyes, Headache and Sinus Pressure

ONLY
1
PILL
EVERY
4-6
HOURS

20
COATED
CAPLETS*

*Capsule-Shaped Tablets

PRINCIPAL DISPLAY PANEL - 20 Tablet Blister Pack Carton
ADVIL ALLERGY SINUS 
chlorpheniramine maleate, ibuprofen, pseudoephedrine hcl tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0573-0188
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE2 mg
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE30 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX (UNII: R12CBM0EIZ)  
STARCH, CORN (UNII: O8232NY3SJ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GLYCERYL DIBEHENATE (UNII: R8WTH25YS2)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYDEXTROSE (UNII: VH2XOU12IE)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
Product Characteristics
ColorORANGE (bright orange) Scoreno score
ShapeOVAL (oval shaped tablet) Size15mm
FlavorImprint Code Advil;A;S
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0573-0188-1020 in 1 CARTON12/20/2002
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02144112/20/2002
Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)
Registrant - Pfizer Inc (113480771)
Establishment
NameAddressID/FEIBusiness Operations
Wyeth Pharmaceuticals Company829390975ANALYSIS(0573-0188) , LABEL(0573-0188) , MANUFACTURE(0573-0188) , PACK(0573-0188)

Revised: 11/2020
Document Id: 35898b4b-2bef-4086-bff6-ee0c0599c092
Set id: ecd6ea11-8b34-01b4-cbd9-901ba7a8f6e2
Version: 10
Effective Time: 20201111
 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC