ADVIL ALLERGY AND CONGESTION RELIEF- chlorpheniramine maleate, ibuprofen, phenylephrine hydrochloride tablet, coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U), IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM), PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)

Available from:

Navajo Manufacturing Company Inc.

INN (International Name):

CHLORPHENIRAMINE MALEATE

Composition:

CHLORPHENIRAMINE MALEATE 4 mg

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

• 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 • fever • minor body aches and pains • reduces swelling of the nasal passages • temporarily restores freer breathing through the nose

Authorization status:

New Drug Application

Summary of Product characteristics

ADVIL ALLERGY AND CONGESTION RELIEF- CHLORPHENIRAMINE MALEATE,
IBUPROFEN, PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED
NAVAJO MANUFACTURING COMPANY INC.
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ADVIL ALLERGY & CONGESTION RELIEF
_DRUG FACTS_
_ACTIVE INGREDIENTS (IN EACH TABLET)_
Chlorpheniramine Maleate 4 mg
Ibuprofen 200 mg (NSAID)*
Phenylephrine HCl 10 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 • fever • minor body aches and pains
• 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 • 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 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 condi