IBUPROFEN by Raining Rose Inc.
Dosage form: tablet, film coated
Ingredients: IBUPROFEN 200mg
Labeler: Raining Rose Inc.
NDC Code: 65692-0412
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Active ingredient (in each tablet)
Ibuprofen (NSAID)* 200 mg
*nonsteroidal anti-inflammatory drug
Pain reliever/fever reducer
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
• Temporarily relieves minor aches and pains associated with • headache • toothache • backache • menstrual cramps • common cold • muscular aches • minor arthritis pain • Temporarily reduces fever.
Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
• hives • skin reddening • facial swelling • rash • asthma (wheezing) • blister • shock 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 thinner (anticoagulant) or steroid drug • take other drugs containing prescription or nonprescription NSAIDs (asprin, 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 you have ever had an allergic reaction to any other pain reliever/fever reducer • right before or after heart surgery
• stomach bleeding warning applies to you • you have a history of stomach problems such as heartburn • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease • you are taking a diuretic • you have problems or serious side effects from taking pain relivers or fever reducers • you have asthma
• taking aspirin for heart attack or stroke, because ibuprofen may decrease the benefit or aspirin • taking any other drug • under a doctor's care for any serious condition
• the risk of a heart attack or stroke may increase if you use more than directed or longer than directed • take with food or milk if stomach upset occurs
• you experience any of the following signs of stomach bleeding: • feel faint • vomit blood • have bloody or blackstools • 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 or unexpected symptoms appear.
ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless specifically directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
• do not use 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: Do not give to children under 12 years of age.
carnauba wax, corn starch, fumed silia gel, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, red irion oxide, sodium starch glycolate, stearic acid, titanium dioxide.
• read all product information before using.
Store at 68-77°F (20-25°C) • Avoid ecessive heat, above 104°F (40°C).
12 Ibuprofen Tablets USP, 200 mPain Reliever/Fever Reducer (NSAID)
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Do not use if safety seal is broken.
TAMPER EVIDENT: DO NOT USE IF THIS SAFETY SEAL AROUND CAP IS BROKEN OR MISSING
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Dist. By Raining Rose, Inc. Cedar Rapids, IA 52403
ibuprofen tablet, film coated
|Labeler - Raining Rose Inc. (083819404)|
|Registrant - Raining Rose Inc. (083819404)|
|Raining Rose Inc.||083819404||manufacture(65692-0412), relabel(65692-0412), repack(65692-0412)|
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.