Label: IBUPROFEN suspension

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

Drug Label Information

Updated March 31, 2025

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  • Active ingredient (in each 5 mL = 1 teaspoonful)
    Ibuprofen 100 mg (NSAID)* *nonsteroidal anti-inflammatory drug
  • Purposes
    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; tsp = teaspoonful - find right dose on chart. If ...
  • Other information
    each 5 mL (1 tsp) contains: sodium 2 mg - do not use if printed neckband is broken or missing - store at 20-25 C (68-77 F) °° do not freeze - see bottom panel for lot number and expiration ...
  • Inactive ingredients
    anhydrous citric acid, artificial mixed berry flavor, D&C yellow #10, FD&C red #40, glycerin, high fructose corn syrup, hypromellose, polysorbate 80, purified water, sodium benzoate, sorbitol ...
  • Questions or comments?
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