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 Contract Pharmacy Services-pa. 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.
Active Ingredient (In Each Tablet)
Ibuprofen 200 mg (NSAID)*
*nonsteroidal anti-inflammatory drug
Purpose
Pain reliever/fever reducer
Uses
- temporarily relieves minor aches and pains due to:
- muscular aches
- minor pain of arthritis
- toothache
- backache
- the common cold
- menstrual cramps
- temporarily reduces fever
Do Not Use
• if you have ever had an allergic reaction to any other pain reliever/fever reducer
• right before or after heart surgery
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
- 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
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 chances are higher if you
Ask A Doctor Before Use If You Are
- taking aspirin to prevent heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
- under a doctor’s care for any serious condition
- taking any other drugs
When Using This Product
- take with food or milk if stomach upset occurs
- the risk of heart attack or stroke may increase if you use more than directed or for longer than directed
Stop Use And Ask A Doctor If
- you experience any of the following 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
If Pregnant Or Breast-Feeding,
ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
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
Directions
- do not take more than directed
- the smallest effective dose should be used
- do not take longer than 10 days, unless directed by a doctor (see Warnings)
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 doctorchildren under 12 years ask a doctor
Other Information
- read all warnings and directions before use
- store at 20-25°C (68-77°F)
- avoid high humidity and excessive heat above 40°C (104°F)
Inactive Ingredients
colloidal silicon dioxide, corn starch, croscarmellose sodium, hypromellose, iron oxides, microcrystalline cellulose, polyethylene glycol, polysorbate 80, stearic acid, titanium dioxide
Questions Or Comments?
Distributed by: Major Pharmaceuticals, 31778 Enterprise Drive, Livonia, MI 48150, U.S.A.
call toll free 734-743-6000
Repackaged by:
Contract Pharmacy Services-PA
125 Titus Ave Suite 200
Warrington, PA 18976 USA
Original--08/2010--NJW
Package Label
Blister of 30 Tablets
* Please review the disclaimer below.