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  5. Label Information: Health Sense Infants Ibuprofen Oral Suspension

FDA Label for Health Sense Infants Ibuprofen Oral Suspension

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (IN EACH 1.25 ML)
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. DO NOT USE
    6. ASK A DOCTOR BEFORE USE IF THE CHILD HAS
    7. ASK A DOCTOR OR PHARMACIST BEFORE USE IF THE CHILD IS
    8. WHEN USING THIS PRODUCT
    9. STOP USE AND ASK A DOCTOR IF
    10. KEEP OUT OF REACH OF CHILDREN.
    11. DIRECTIONS
    12. OTHER INFORMATION
    13. INACTIVE INGREDIENTS
    14. QUESTIONS OR COMMENTS?
    15. PRINCIPAL DISPLAY PANEL

Health Sense Infants Ibuprofen Oral Suspension Product Label

The following document was submitted to the FDA by the labeler of this product Dolgencorp Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient (In Each 1.25 Ml)



Ibuprofen 50 mg (NSAID)*

*nonsteroidal anti-inflammatory drug


Purpose



Pain reliever/fever reducer


Uses



temporarily:

  • reduces fever
  • relieves minor aches and pains due to the common cold, flu, sore throat, headaches and toothaches

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 reddening
  • rash
  • blisters

    • If an allergic reaction occurs, stop use and seek medical help right away.

    Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause stomach bleeding.

    The chance is higher if the child:

    • has had stomach ulcers or bleeding problems
    • takes a blood thinning (anticoagulant) or steroid drug
    • takes other drugs containing an NSAID [aspirin, ibuprofen, naproxen, or others]
    • takes more or for a longer time than directed

      • Sore throat warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult doctor promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by doctor.


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 The Child Has



  • problems or serious side effects from taking pain relievers or fever reducers
  • stomach problems that last or come back, such as heartburn, upset stomach, or stomach pain
  • ulcers
  • bleeding problems
  • not been drinking fluids
  • lost a lot of fluid due to vomiting or diarrhea
  • high blood pressure
  • heart or kidney disease
  • taken a diuretic

Ask A Doctor Or Pharmacist Before Use If The Child Is



  • taking any other drug containing an NSAID (prescription or nonprescription)
  • taking a blood thinning (anticoagulant) or steroid drug
  • under a doctor’s care for any serious condition
  • taking any other drug

When Using This Product



  • give with food or milk if stomach upset occurs
  • long term continuous use may increase the risk of heart attack or stroke

Stop Use And Ask A Doctor If



  • the child feels faint, vomits blood, or has bloody or black stools. These are signs of stomach bleeding.
  • stomach pain or upset gets worse or lasts
  • the child does not get any relief within first day (24 hours) of treatment
  • fever or pain gets worse or lasts more than 3 days
  • redness or swelling is present in the painful area
  • any new symptoms appear

Keep Out Of Reach Of Children.



In case of overdose, get medical help or contact a Poison Control Center right away.


Directions



  • this product does not contain directions or complete warnings for adult use
  • do not give more than directed
  • do not give longer than 10 days, unless directed by a doctor (see Warnings)
  • shake well before using
  • find the right dose on chart below. If possible, use weight to dose; otherwise use age.
  • measure with dosing device provided. Do not use with any other device.
  • dispense liquid slowly into the child’s mouth, toward the inner cheek
  • if needed, repeat dose every 6-8 hours
  • do not use more than 4 times a day

    • Dosing Chart

    Weight (lb)Age (mos)Dose (mL)
    under 6 mosask a doctor
    12-17 lbs6-11 mos1.25 mL
    18-23 lbs12-23 mos1.875 mL

Other Information



  • do not use if printed neckband is broken or missing
  • store at 20-25°C (68-77°F)
  • see bottom of box for lot number and expiration date

Inactive Ingredients



artificial flavor, butylparaben, citric acid, FD&C red #40, glycerin, hypromellose, polysorbate 80, propylene glycol, purified water, sodium benzoate, sorbitol, sucrose, xanthan gum


Questions Or Comments?



1-888-309-9030


Principal Display Panel



 Compare to active ingredient of Motrin® Infants' Drops

Concentrated

For Ages 6 mos.-23 mos.

Infants' Ibuprofen Oral Suspension

50 mg per 1.25 mL

Pain Reliever/Fever Reducer (NSAID)

Lasts up to 8 hours

Alcohol Free

Use Only With Enclosed Syringe

Berry Flavor

Product Carton - 78f524ac 3498 480d 8979 653c8a5c5674 01

Product Carton - 78f524ac 3498 480d 8979 653c8a5c5674 01

Product CartonProduct Label

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