Label: IBUPROFEN IMMEDIATE RELEASE- ibuprofen tablet, coated
- NDC Code(s): 59556-857-42, 59556-858-42
- Packager: Strides Pharma Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated May 22, 2024
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- BOXED WARNING (What is this?)
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ACTIVE INGREDIENTActive ingredient (in each Brown tablet or caplet**) Ibuprofen 200 mg (NSAID)* * nonsteroidal anti-inflammatory drug - **capsule-shaped tablets
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PURPOSEPurpose - Pain reliever / fever reducer
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Uses
temporarily relieves minor aches and pains due to: headache - muscular aches - minor pain of arthritis - toothache - backache - the common cold - menstrual cramps - temporarily reduces fever
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Warnings
Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: hives - facial swelling asthma (wheezing) shock ...
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Do not Useif you have ever had an allergic reaction to ibuprofen or any other pain reliever / fever reducer - right before or after heart surgery
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ASK DOCTOR/PHARMACISTAsk a doctor before use if - you have problems or serious side effects from taking pain relievers or fever reducers - the stomach bleeding warning applies to you - you have a history of stomach ...
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SPL UNCLASSIFIED SECTIONAsk a doctor or pharmacist before use if you are - taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin - under a doctor's care for any serious ...
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WHEN USINGWhen using this product - take with food or milk if stomach upset occurs
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STOP USEStop 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 ...
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PREGNANCY OR BREAST FEEDINGIf pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen at 20 weeks or later in pregnancy unless definitely directed to do so by a ...
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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. (1-800-222-1222)
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SPL UNCLASSIFIED SECTIONDirections - 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 ...
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STORAGE AND HANDLINGOther Information - store between 20-250C (68-770F) do not use if carton is opened. Do not use if foil inner seal imprinted with "Sealed For Your Safety" is broken or missing
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Inactive Ingredients
colloidal silicon dioxide, corn starch, hypromellose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, red iron oxide, sodium starch glycolate, talc, titanium dioxide and ...
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Questions or Comments?Call 1-855-742-7868 (toll-free)
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SPL UNCLASSIFIED SECTIONManufactured by: Strides Pharma Science Limited, Puducherry - 605 014, India. Distributed by: Strides Pharma Inc. East Brunswick, NJ 08816 - January 2022
- DOSAGE & ADMINISTRATION
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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCEProduct Information