Label: LEADER CHILDRENS IBUPROFEN- ibuprofen suspension

  • NDC Code(s): 70000-0263-1, 70000-0263-2, 70000-0263-3
  • Packager: Cardinal Health 110, LLC. dba Leader
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated March 3, 2025

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

  • Active ingredient (in each 5 mL)
    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 - • find right dose on chart. If ...
  • Other information
    • each 5 mL 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
  • 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?
    1-800-719-9260
  • Principal Display Panel
    LEADER™ SEE NEW WARNINGS - Children’s Ibuprofen - Oral Suspension - 100 mg per 5 mL - Pain Reliever / Fever Reducer (NSAID) Berry Flavor - For Ages 2 to 11 Years - COMPARE TO CHILDREN’S MOTRIN® active ...
  • INGREDIENTS AND APPEARANCE
    Product Information