FDA Label for Ibuprofen
View Indications, Usage & Precautions
Ibuprofen Product Label
The following document was submitted to the FDA by the labeler of this product Target Corporation. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
ACTIVE INGREDIENT(S)
Ibuprofen 200 mg (NSAID)*
* nonstreoidal anti-inflammatory drug
Inactive Ingredient
INACTIVE INGREDIENTS
Silicon dioxide, croscarmellose sodium, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc, titanium dioxide.
Otc - Purpose
PURPOSE
Pain reliever / fever reducer
Indications & Usage
USE(S)
temporarily relieves minor aches and pains due to :
backache
headache
menstrual cramps
minor pain of arthritis
muscular aches
the common cold
toothache
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 older
take 1 tablet every 4 to 6 hours while symptoms persist
if pain or fever does not respond to 1 tablet, 2 tablets may be used
do not exceed 6 tablets in 24 hours, unless directed by a doctor.
Children under 12 years
ask a doctor
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 right away. (1-800-222-1222
Warnings
WARNINGS
Allergy alerts: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin.
Symptoms may include: asthma (wheezing),blisters,facial swelling,hives,rash,shock,skin reddening
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 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 drug containing prescription NSAID (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.
Package Label.Principal Display Panel
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