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?)

    Important: Read all product information before using.

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  • ACTIVE INGREDIENT
    Active ingredient (in each Brown tablet or caplet**) Ibuprofen 200 mg (NSAID)* * nonsteroidal anti-inflammatory drug - **capsule-shaped tablets
  • PURPOSE
    Purpose - Pain reliever / fever reducer
  • 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
  • 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 ...
  • Do not Use
    if you have ever had an allergic reaction to ibuprofen or any other pain reliever / fever reducer - right before or after heart surgery
  • ASK DOCTOR/PHARMACIST
    Ask 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 ...
  • SPL UNCLASSIFIED SECTION
    Ask 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 ...
  • WHEN USING
    When using this product - take with food or milk if stomach upset occurs
  • STOP USE
    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 ...
  • PREGNANCY OR BREAST FEEDING
    If 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 ...
  • KEEP OUT OF REACH OF CHILDREN
    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)
  • SPL UNCLASSIFIED SECTION
    Directions - 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 ...
  • STORAGE AND HANDLING
    Other 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
  • Inactive Ingredients
    colloidal silicon dioxide, corn starch, hypromellose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, red iron oxide, sodium starch glycolate, talc, titanium dioxide and ...
  • Questions or Comments?
    Call 1-855-742-7868 (toll-free)
  • SPL UNCLASSIFIED SECTION
    Manufactured by: Strides Pharma Science Limited, Puducherry - 605 014, India. Distributed by: Strides Pharma Inc. East Brunswick, NJ 08816 - January 2022
  • DOSAGE & ADMINISTRATION
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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  • INGREDIENTS AND APPEARANCE
    Product Information