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  5. Label Information: Topcare Infants Ibuprofen

FDA Label for Topcare Infants Ibuprofen

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (IN EACH 1.25 ML)
    2. PURPOSES
    3. USES
    4. WARNINGS
    5. DO NOT USE
    6. ASK A DOCTOR BEFORE USE IF
    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

Topcare Infants Ibuprofen Product Label

The following document was submitted to the FDA by the labeler of this product Topco Associates Llc. 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


Purposes



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 an NSAID, which may cause severe stomach bleeding.

    The chance is higher if your child:

    • •has had stomach ulcers or bleeding problems
    • •takes a blood thinning (anticoagulant) or steroid drug
    • •takes other drugs containing prescription or nonprescription NSAIDs [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 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 reducers
  • •child has not been drinking fluids
  • •child has lost a lot of fluid due to vomiting or diarrhea
  • •child has high blood pressure, heart disease, liver cirrhosis, or kidney disease
  • •child has asthma
  • •child is taking a diuretic

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



  • •give with food or milk if stomach upset occurs
  • •the risk of heart attack or stroke may increase if you use more than directed or for longer than directed

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
  • •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. (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
  • •find right dose on chart below. If possible, use weight to dose; otherwise use age.
  • •measure with the 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 (lbs)

    Age (mos)

    Dose (mL)

    under 6 mos

    ask a doctor

    12-17 lbs

    6-11 mos

    1.25 mL

    18-23 lbs

    12-23 mos

    1.875 mL


Other Information



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

Inactive Ingredients



anhydrous citric acid, FD&C red #40, glycerin, hypromellose, natural and artificial berry flavor, polysorbate 80, purified water, sodium benzoate, sorbitol solution, sucrose, xanthan gum


Questions Or Comments?



1-888-423-0139


Principal Display Panel



FOR AGES 6 MOS. TO 23 MOS.

CONCENTRATED DROPS

Infants’

Ibuprofen Oral Suspension

50 mg per 1.25 mL

Pain Reliever / Fever Reducer (NSAID)

Lasts up to 8 hours

No high fructose corn syrup

Use only with enclosed syringe

BERRY FLAVOR

COMPARE TO MOTRIN® INFANTS’ DROPS active ingredient

½ FL OZ (15 mL)


* Please review the disclaimer below.