Label: CHILDRENS IBUPROFEN ORAL SUSPENSION, BUBBLE GUM- ibuprofen suspension

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

Drug Label Information

Updated January 20, 2025

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  • SPL UNCLASSIFIED SECTION
    Drug Facts
  • ACTIVE INGREDIENT
    Active ingredient - (in each 5 mL) Ibuprofen 100 mg (NSAID)* *nonsteroidal anti-inflammatory drug
  • PURPOSE
    Purpose - Pain reliever/ fever reducer
  • INDICATIONS & USAGE
    Uses temporarily: ■ relieves minor aches and pains due to the common cold,    flu, sore throat, headache and toothache - ■ reduces fever
  • WARNINGS
    Warnings - Allergy alert: Ibuprofen may cause a severe allergic - reaction, especially in people allergic to aspirin. Symptoms - may include:     ■ hives  ■ facial swelling  ■asthma (wheezing ...
  • DO NOT USE
    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 DOCTOR
    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 ...
  • ASK DOCTOR/PHARMACIST
    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
    When using this product - ■ take with food or milk if stomach upset occurs
  • STOP USE
    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 ...
  • KEEP OUT OF REACH OF CHILDREN
    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)
  • DOSAGE & ADMINISTRATION
    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 ...
  • OTHER SAFETY INFORMATION
    Other information - ■ each 5 mL contains: sodium 2 mg - ■ store between 20-25° C (68-77° F) ■ do not use if printed neckband is broken or missing
  • INACTIVE INGREDIENT
    Inactive ingredients - Acesulfame potassium, anhydrous citric acid, carboxymethylcellulose sodium, D&C Red #33, FD&C Red - #40, flavors, glycerin, microcrystalline cellulose, polysorbate - 80 ...
  • QUESTIONS
    Questions or comments? Call weekdays from 9:30 AM to 4:30 PM EST at - 1-732-314-4550
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    Package Labeling: Best Choice® Children's Ibuprofen Oral Suspension, Bubble Gum Flavor - Best Choice​®​ Children's - Ibuprofen - Oral Suspension (NSAID) 100 mg per 5 ml - Pain Reliever/Fever ...
  • INGREDIENTS AND APPEARANCE
    Product Information