IBUPROFEN- ibuprofen tablet
Cardinal Health
Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
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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
Temporarily relieves minor aches and pains due to: muscular aches, the common cold, temporarily reduces fever, headache, minor pain of arthritis, backache, menstrual cramps and toothache.
This package is intended for institutional use only. Read all warnings and directions before use.
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. )
Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: hives, asthma (wheezing), skin reddening, facial-swelling, shock, rash and 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 stomach bleeding The chance is higher if you: are age 60 or older, if you have had stomach ulcers or bleeding problems, if you take a blood thinning (anticoagulant) or steroid drug, if you take other drugs containing an NSAID [aspirin, ibuprofen, naproxen, or others], if you have 3 or more alcoholic drinks every day while using this product, or if you take more for a longer time than directed.
Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer. Do not use right before or after heart surgery.
Ask a doctor before use if you have problems or serious side effects from taking pain relievers or fever reducers, if stomach problems last or come back, such as heartburn, upset stomach, or stomach pain, ulcers, asthma, bleeding problems, high blood pressure, heart or kidney disease, taken a diuretic or have reached age 60 or older.
Ask a doctor or pharmacist before use if you are taking any other drug containing an NSAID (prescription or nonprescription), if you are taking a blood thinning (anticoagulant) or steroid drug, if you are under a doctor's care for any serious condition or if taking any other drug.
When using this product take with food or milk if stomach upset occurs or long term continuous use may increase the risk of heart attack or stroke.
Stop use and ask a doctor if you feel faint, vomit blood, or have bloody or black stools. These are signs of stomach bleeding. Stop use and ask a doctor if pain gets worse or lasts more than 10 days, if fever gets worse or lasts, more than 3 days, stomach pain or upset gets worse or lasts, redness or swelling is present in the painful area or any new symptoms appear.
Read all warnings and directions before use.
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 doctor. Children under 12 years Do Not Use.
Cellulose, corn starch, fumed silica gel, hypromellose, lactose, magnesium stearate, polydextrose, polythylene glycol, povidone, silica, sodium starch glycolate, stearic acid, titanium dioxide, triacetin.
Store at 20-25 C (68-77 F); excursions permitted to 15-30 C (59-86 F). [See USP Controlled Room Temperature]
Distributed by: MAJOR PHARMACEUTICALS
31778 Enterprise Drive, Livonia, MI 48150 USA
Re-Order No. 236118
Questions? Adverse Drug Event Call: (800) 616-2471
MFGD BY LNK, Hauppauge, NY 11788
Repackaged by Cardinal Health
Zanesville, OH 43701
IBUPROFEN
ibuprofen tablet |
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Labeler - Cardinal Health (188557102) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
Cardinal Health | 188557102 | REPACK |