Label: CHILDRENS IBUPROFEN- ibuprofen suspension

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

Drug Label Information

Updated February 4, 2025

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT (in each 5 mL)
    Ibuprofen, USP 100 mg (NSAID)* *nonsteroidal anti-inflammatory drug
  • PURPOSE
    Pain reliever/fever reducer
  • USE(S)
    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 - asthma (wheezing) skin reddening - facial ...
  • DO NOT USE
    if the child has ever had an allergic reaction to ibuprofen or any other pain reliever/fever reducer - right before or after heart surgery
  • ASK A DOCTOR BEFORE USE IF
    stomach bleeding warning applies to your child - child has a history of stomach problems, such as heartburn - child has problems or serious side effects from taking pain relievers or fever ...
  • ASK A DOCTOR OR PHARMACIST BEFORE USE IF THE CHILD IS
    under a doctor's care for any serious condition - taking any other drug
  • WHEN USING THIS PRODUCT
    take with food or milk if stomach upset occurs
  • STOP USE AND ASK DOCTOR IF
    child experiences any of the following signs of stomach bleeding - feels faint - vomits blood - has bloody or black stools - has stomach pain that does not get better - child has symptoms of heart problems ...
  • 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)
  • 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 possible, use ...
  • OTHER INFORMATION
    each 5 mL contains: sodium 2 mg - store between 20-25oC (68-77oF) do not use if carton is opened or if printed inner seal imprinted with "SEALED for YOUR PROTECTION" is broken or missing.
  • INACTIVE INGREDIENTS
    anhydrous citric acid, D&C yellow no. 10, FD&C red no. 40, flavor, glycerin, polysorbate 80, pregelatinized starch, purified water, sodium benzoate, sucrose, xanthan gum
  • QUESTIONS OR COMMENTS?
    call 1-609-860-2600 (Monday - Friday 8:00 am - 4:30 pm EST)
  • PRINCIPAL DISPLAY PANEL
    Compare to the active ingredient in Children's Motrin®* Harris Teeter™ NDC 69256-634-03 - Children's - Ibuprofen - Oral Suspension, USP (NSAID) 100 mg per 5 mL - PAIN RELIEVER/FEVER REDUCER - For ...
  • INGREDIENTS AND APPEARANCE
    Product Information