Childrens Ibuprofen

Cardinal Health

CHILDREN'S IBUPROFEN ORAL SUSPENSION Berry Flavor

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active Ingredient (in each 5 mL = 1 teaspoonful)
• Purposes
• Childrens Ibuprofen Uses
• Warnings
  • Allergy alert
  • Stomach bleeding warning
  • Sore throat warning
  • Do not use
  • Ask a doctor before use if
  • Ask a doctor or pharmacist before use if the child is
  • When using this product
  • Stop use and ask a doctor if
• Directions
• Other Information
• Inactive Ingredients
• How Supplied
• PRINCIPAL DISPLAY PANEL - Bag

FULL PRESCRIBING INFORMATION

100 mg/5 mL   200 mg/10 mL

For Hospital Use Only

Drug Facts

Active Ingredient (in each 5 mL = 1 teaspoonful)

Ibuprofen 100 mg (NSAID)

nonsteroidal anti-inflammatory drug

Purposes

Pain reliever/Fever reducer

Childrens Ibuprofen 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.

Warnings

Allergy alert

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

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

• 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)
• 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

Alcohol Free, Gluten Free

How Supplied

NDC 68094-494-58
5 mL per unit dose syringe
Fifty (50) unit dose syringes per shipper

NDC 68094-494-61
5 mL per unit dose cup
One hundred (100) cups per shipper

NDC 68094-494-62
5 mL per unit dose cup
Thirty (30) cups per shipper

NDC 68094-503-61
10 mL per unit dose cup
One hundred (100) cups per shipper

NDC 68094-503-62
10 mL per unit dose cup
Thirty (30) cups per shipper

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

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

LI 587
Rev. 04/11

PRINCIPAL DISPLAY PANEL - Bag

Children's Ibuprofen Oral Suspension

100 mg/5ml

5 Unit Dose Cups