Ibuprofen mini

FDA Drug Profile — Ibuprofen mini

Ibuprofen mini is listed in the FDA National Drug Code directory with 1 NDC code, marketed under brand name including Ibuprofen mini. Available dosage form: capsule, liquid filled.

Drug Details

Generic Name
Ibuprofen mini
Brand Names
Ibuprofen mini
Application Number
ANDA206568
Sponsor
Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd
NDC Codes
1
Dosage Forms
CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients
IBUPROFEN

Indications and Usage

Uses temporarily relieves minor aches and pains due to: headache toothache backache menstrual cramps the common cold muscular aches minor pain of arthritis temporarily reduces 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.