Drug Facts
Composition & Profile
Identifiers & Packaging
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 1f80343c-figure-01 1f80343c-figure-02 1f80343c-figure-03
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 1f80343c-figure-01 1f80343c-figure-02 1f80343c-figure-03
Overview
INDICATIONS AND USAGE 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
Indications & Usage
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
Dosage & Administration
DIRECTIONS do not take more than directed the smallest effective dose should be used adults and children 12 years and over: take 1 capsule every 4 to 6 hours while symptoms persist if pain or fever does not respond to 1 capsule, 2 capsules may be used. do not exceed 6 capsules in 24 hours, unless directed by a doctor children under 12 years: ask a doctor
Warnings & Precautions
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 a nonsteroidal anti-inflammatory drug (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
Purpose
OTC - PURPOSE Pain reliever/Fever reducer
Do Not Use
OTC - DO NOT USE Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer right before or after heart surgery
When Using
OTC - WHEN USING When using this product take with food or milk if upset stomach occurs the risk of heart attack or stroke may increase if you use more than directed or for longer than directed
Stop Use & Ask a Doctor
OTC - STOP USE Stop use and ask a doctor if you experience any of the follwing 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 10 days fever gets worse or lasts more than 3 days redness or swelling is present in the painful area any new symptoms appear
Keep Out of Reach of Children
OTC - KEEP OUT OF REACH OF CHILDREN Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Questions
OTC – QUESTIONS OR COMMENTS? Call 1-877-835-5472 Monday through Friday 9AM - 5PM EST READ AND KEEP CARTON FOR COMPLETE WARNINGS AND INFORMATION Do Not Use if printed foil under cap is broken or missing. Distributed by: Amneal Pharmaceuticals Glasgow, KY 42141 Rev. 08-2011
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