Label: IBUPROFEN tablet, film coated
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Contains inactivated NDC Code(s)
NDC Code(s): 65692-0412-1 - Packager: Raining Rose Inc.
- Category: HUMAN OTC DRUG LABEL
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.
Drug Label Information
Updated November 5, 2019
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Drug FactsActive ingredientActive ingredient (in each tablet) Ibuprofen (NSAID)* 200 mg - *nonsteroidal anti-inflammatory drug
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PurposePain reliever/fever reducer
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Keep out of reach of childrenKeep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
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Uses• Temporarily relieves minor aches and pains associated with • headache • toothache • backache • menstrual cramps • common cold • muscular aches • minor arthritis pain • Temporarily reduces ...
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Warnings Allergy Alert: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 ...
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Do not use• if you have ever had an allergic reaction to any other pain reliever/fever reducer • right before or after heart surgery
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Ask a doctor before use if• 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 ...
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Ask a doctor or pharmacist before use if you are• 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
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When using this product• 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
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Stop use and ask a doctor if• 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 ...
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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 specifically directed to do so by a doctor because it may cause ...
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Directions• 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 ...
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Inactive ingredients:carnauba wax, corn starch, fumed silia gel, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, red irion oxide, sodium starch glycolate ...
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Other Information• read all product information before using. Store at 68-77°F (20-25°C) • Avoid ecessive heat, above 104°F (40°C).
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Ibuprofen product label(What is this?)IBUPROFEN - 12 Ibuprofen Tablets USP, 200 mPain Reliever/Fever Reducer (NSAID) LOT CODE: EXP DATE: OPEN HERE TO VIE COMPLETE PRODUCT INFORMATION - Do not use if safety seal is broken. TAMPER ...
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INGREDIENTS AND APPEARANCEProduct Information