ADVIL ALLERGY SINUS

Dosage form: tablet, coated
Ingredients: CHLORPHENIRAMINE MALEATE 2mg, IBUPROFEN 200mg, PSEUDOEPHEDRINE HYDROCHLORIDE 30mg
Labeler: Pfizer Consumer Healthcare
NDC Code: 0573-0188

Advil Allergy Sinus
(chlorpheniramine maleate, ibuprofen, and psuedoephedrine HCl)

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

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, or trouble urinating due to an enlarged prostate gland
  • 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
  • the risk of heart attack or stroke may increase if you use more than directed or for longer than directed
  • 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
  • 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, propylene glycol, silicon dioxide, titanium dioxide

QUESTIONS OR COMMENTS?

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

Pfizer, Madison, NJ 07940 USA ©2011 Pfizer Inc.

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

U.S. Patent number 7,863,287

PRINCIPAL DISPLAY PANEL - 10 Tablet Blister Pack

Advil®
ALLERGY SINUS
Ibuprofen 200 mg /
Pseudoephedrine HCl 30 mg /
Chlorpheniramine Maleate 2 mg
See warnings before use.
Pfizer, Madison, NJ 07940 USA

AREA FOR EXP. & LOT

PEEL & PUSH

PRINCIPAL DISPLAY PANEL - 20 Tablet Blister Pack Carton

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

ADVIL ALLERGY SINUS 
chlorpheniramine maleate, ibuprofen, pseudoephedrine hcl tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0573-0188
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORPHENIRAMINE MALEATE (CHLORPHENIRAMINE) CHLORPHENIRAMINE MALEATE2 mg
IBUPROFEN (IBUPROFEN) IBUPROFEN200 mg
PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE) PSEUDOEPHEDRINE HYDROCHLORIDE30 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX 
SILICON DIOXIDE 
STARCH, CORN 
CROSCARMELLOSE SODIUM 
FD&C RED NO. 40 
FD&C YELLOW NO. 6 
GLYCERYL DIBEHENATE 
CELLULOSE, MICROCRYSTALLINE 
POLYDEXTROSE 
HYPROMELLOSES 
POLYETHYLENE GLYCOLS 
TITANIUM DIOXIDE 
Product Characteristics
ColorORANGE (bright orange) Scoreno score
ShapeOVAL (oval shaped tablet) Size15mm
FlavorImprint CodeAdvil;A;S
Contains    
Packaging
#Item CodePackage Description
1NDC:0573-0188-1020 BLISTER PACK in 1 CARTON
11 TABLET, COATED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02144112/20/2002
Labeler - Pfizer Consumer Healthcare (828831730)
Establishment
NameAddressID/FEIOperations
Wyeth Pharmaceuticals Company, Consumer Site829390975ANALYSIS(0573-0188), LABEL(0573-0188), MANUFACTURE(0573-0188), PACK(0573-0188)

Revised: 01/2014
 
Pfizer Consumer Healthcare

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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