Label: IBUPROFEN suspension

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated February 26, 2025

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  • SPL UNCLASSIFIED SECTION
    Drug Facts
  • Active ingredient (in each 5 mL)
    Ibuprofen 100 mg (NSAID)1 - 1 - nonsteroidal anti-inflammatory drug
  • Purpose
    Pain reliever/fever reducer
  • Uses
    temporarily: • relieves minor aches and pains due to the common cold, flu, sore throat, headache and toothache - • 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 - • skin ...
  • Directions
    • this product does not contain directions or complete warnings for adult use - • do not give more than directed - • shake well before using - • mL = milliliter - • find right dose on chart. If ...
  • Other information
    • Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. • do not use if carton is opened or if bottle wrap imprinted with "SEALED FOR SAFETY" is broken or missing - • see ...
  • Inactive ingredients
    acesulfame potassium, berry flavor natural & artificial, citric acid anhydrous, glycerin, polysorbate 80, pregelatinized modified starch, purified water, sodium benzoate, sucrose, xanthan ...
  • Questions?
    Call 1-866-923-4914
  • SPL UNCLASSIFIED SECTION
    Distributed by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532 - Relabeled By: Preferred Pharmaceuticals Inc.
  • PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton
    *Compare to the active - ingredient in Children's - Motrin® Dye-Free Berry Flavor - NDC 68788-8288-1 - See New Warnings - For ages 2 to 11 years - Children's - Ibuprofen - Oral Suspension, USP - 100 mg per 5 ...
  • INGREDIENTS AND APPEARANCE
    Product Information