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  5. Label Information: Childrens Ibuprofen

FDA Label for Childrens Ibuprofen

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT (IN EACH 5 ML = 1 TEASPOONFUL)
    3. PURPOSES
    4. USES
    5. ALLERGY ALERT
    6. STOMACH BLEEDING WARNING
    7. SORE THROAT WARNING
    8. DO NOT USE
    9. ASK A DOCTOR BEFORE USE IF
    10. ASK A DOCTOR OR PHARMACIST BEFORE USE IF THE CHILD IS
    11. WHEN USING THIS PRODUCT
    12. STOP USE AND ASK A DOCTOR IF
    13. OTC - KEEP OUT OF REACH OF CHILDREN
    14. DIRECTIONS
    15. OTHER INFORMATION
    16. INACTIVE INGREDIENTS
    17. HOW SUPPLIED
    18. PRINCIPAL DISPLAY PANEL

Childrens Ibuprofen Product Label

The following document was submitted to the FDA by the labeler of this product Cardinal Health 107, 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.

Other



100 mg/5 mL 200 mg/10 mL

For Hospital Use Only

Drug Facts

Alcohol Free, Gluten Free

Manufactured By:
Perrigo Company
515 Eastern Avenue
Allegan, MI 49010

Packaged By:
Precision Dose, Inc.
722 Progressive Lane
S. Beloit, IL 61080

Repackaged By:

Cardinal Health

Zanesville, OH 43701

L37247700516

LI 587
Rev. 04/13


Active Ingredient (In Each 5 Ml = 1 Teaspoonful)



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
  • •This product is intended for use in children.

Allergy Alert



Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

  • •hives
  • •facial swelling
  • •blisters
  • •asthma (wheezing)
  • •shock
  • •skin reddening
  • •rash

    • 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



  • •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

Otc - 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)


Directions



  • •use as directed per healthcare professional
  • •this product does not contain directions or complete warnings for adult use
  • •do not give more than directed
  • •shake cups well before using
  • •if needed, repeat dose every 6 - 8 hours
  • •do not use more than 4 times a day

Other Information



  • •each teaspoon contains: sodium 2 mg
  • •store at 20-25°C (68-77°F)
  • •do not freeze
  • •See individual label or shipper label for lot number and expiration date.

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 solution, xanthan gum


How Supplied



Overbagged with 5 x 5 mL per unit dose cup, NDC# 55154-1577-5


Principal Display Panel



Children’s Ibuprofen Oral Suspension

100 mg/ 5 mL

5 Unit Dose Cups


* Please review the disclaimer below.