Ibuprofen and Pseudoephedrine HCl

FDA Drug Profile — Ibuprofen and Pseudoephedrine HCl

Drug Details

Generic Name
Ibuprofen and Pseudoephedrine HCl
Brand Names
Ibuprofen and Pseudoephedrine HCl
Application Number
ANDA209235
Sponsor
Amerisource Bergen
NDC Codes
5
Dosage Forms
CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients
IBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORIDE

Indications and Usage

Uses temporarily relieves these symptoms associated with the common cold or flu: headache sinus pressure nasal congestion minor body aches and pains fever

Warnings

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.