Label: IBUPROFEN ORAL- ibuprofen oral suspension

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

Drug Label Information

Updated January 3, 2025

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

  • ACTIVE INGREDIENT(S)
    (in each 5 mL) Ibuprofen 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 - facial swelling - asthma (wheezing) shock - skin ...
  • DO NOT USE
    if the child has ever had an allergic reaction to 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 better - child has symptoms of heart ...
  • 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 ...
  • Other information
      each 5 mL contains : sodium 2 mg -  store between 20-25°C (68-77°F) do not use if carton is opened or printed bottle neckband is broken or missing -  see bottom panel for lot ...
  • INACTIVE INGREDIENT SECTION
    Berry flavor (with dye) Acesulfame potassium, anhydrous citric acid, carboxymethylcellulose sodium, D&C Yellow #10, FD&C Red #40, flavors, glycerin, microcrystalline cellulose, polysorbate ...
  • QUESTIONS SECTION
    Call 1-888-588-1418 from 9 AM to 5 PM EST, Monday-Friday.            Distributed by: Camber Consumer Care, Inc. Piscataway, NJ 08854, USA ...
  • HOW SUPPLIED
    Ibuprofen Oral Suspension Berry Dye Free - NDC 72162-1912-2: 118 mL in a BOTTLE - Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504
  • PRINCIPAL DISPLAY PANEL
    Ibuprofen Oral Suspension Berry Dye Free
  • INGREDIENTS AND APPEARANCE
    Product Information