ADVIL ALLERGY AND CONGESTION RELIEF- chlorpheniramine maleate, ibuprofen and phenylephrine hydrochloride tablet, coated 
Pfizer Consumer Healthcare

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Drug Facts

Active ingredients
(in each tablet)
Purposes
*
nonsteroidal anti-inflammatory drug
Chlorpheniramine maleate 4 mg Antihistamine
Ibuprofen 200 mg (NSAID)* Pain reliever/Fever reducer
Phenylephrine HCl 10 mg 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 body aches and pains
    • fever
  • 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 allergic to aspirin. Symptoms may include:

  • hives
  • asthma (wheezing)
  • skin reddening
  • blisters
  • facial swelling
  • shock
  • rash

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 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

  • 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 have 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 phenylephrine, 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
  • may cause excitability especially in children

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
  • 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 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 take 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

  • 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, artificial flavors, 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

PRINCIPAL DISPLAY PANEL - 10 Tablet Carton

NEW

Advil®

ALLERGY & CONGESTION RELIEF

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

1
PILL
DOSAGE

Relief of: Sinus Pressure, Nasal Swelling &
Congestion, Sneezing, Runny Nose and Headache

10
COATED
TABLETS

PRINCIPAL DISPLAY PANEL - 10 Tablet Carton
ADVIL ALLERGY AND CONGESTION RELIEF 
chlorpheniramine maleate, ibuprofen, and phenylephrine hydrochloride tablet, coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0573-0196
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHLORPHENIRAMINE MALEATE (CHLORPHENIRAMINE) CHLORPHENIRAMINE MALEATE 4 mg
IBUPROFEN (IBUPROFEN) IBUPROFEN 200 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE 10 mg
Inactive Ingredients
Ingredient Name Strength
ACESULFAME POTASSIUM  
CARNAUBA WAX  
CROSCARMELLOSE SODIUM  
GLYCERIN  
LACTIC ACID  
MALTODEXTRIN  
MEDIUM-CHAIN TRIGLYCERIDES  
POLYDEXTROSE  
POLYVINYL ALCOHOL  
PROPYL GALLATE  
SUCRALOSE  
TALC  
TITANIUM DIOXIDE  
TRIACETIN  
XANTHAN GUM  
SILICON DIOXIDE  
STARCH, CORN  
GLYCERYL DIBEHENATE  
HYPROMELLOSES  
EGG PHOSPHOLIPIDS  
CELLULOSE, MICROCRYSTALLINE  
Product Characteristics
Color GRAY Score no score
Shape OVAL Size 17mm
Flavor Imprint Code Advil;A;CR
Contains     
Packaging
# Item Code Package Description
1 NDC:0573-0196-01 50 in 1 TRAY
1 1 in 1 PACKET
2 NDC:0573-0196-10 1 in 1 CARTON
2 10 in 1 BLISTER PACK
3 NDC:0573-0196-20 2 in 1 CARTON
3 10 in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022113 07/23/2012
Labeler - Pfizer Consumer Healthcare (828831730)
Establishment
Name Address ID/FEI Business Operations
Fareva Richmond, Inc. 969523245 ANALYSIS(0573-0196), LABEL(0573-0196), MANUFACTURE(0573-0196), PACK(0573-0196), RELABEL(0573-0196), REPACK(0573-0196)

Revised: 08/2012
Pfizer Consumer Healthcare