Label: CHILDRENS IBUPROFEN- ibuprofen suspension

  • NDC Code(s): 21130-216-20
  • Packager: Better Living Brands, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated March 28, 2025

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

  • Drug Facts
    Active ingredient (in each 5 mL) Ibuprofen USP 100 mg (NSAID)*
  • Purpose
    Pain reliever/fever reducer - *nonsteroidal anti-inflammatory drug
  • 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 ...
  • 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 a 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 ...
  • 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 to 25°C (68 to 77°F) do not use if carton is opened or seal under cap opening is broken or missing - see bottom panel for lot number and ...
  • Inactive ingredients
    Acesulfame potassium, citric acid anhydrous, D&C yellow No. 10, FD&C red No. 40, glycerin, hypromellose, N&A flavor for cherry blast, N&A strawberry flavor wild, polysorbate 80, pregelatinized ...
  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 8 FL OZ (240 mL) Container Label
    NDC 21130-216-20 -   Signature - care®   Quality - Guranteed - FOR - AGES 2 to 11 YEARS - Children’s - Ibuprofen - ORAL SUSPENSION USP - 100 mg per 5 mL -   Pain Reliever/Fever ...
  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 8 FL OZ (240 mL) Carton Label
    Compare to - Children's Motrin® active ingredient**   NDC 21130-216-20 - Signature - care® Quality - Guranteed -   FOR - AGES 2 TO 11 YEARS - Children’s - Ibuprofen - ORAL SUSPENSION ...
  • INGREDIENTS AND APPEARANCE
    Product Information