CHILDRENS IBUPROFEN - ibuprofen suspension 
Cardinal Health

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CHILDREN'S IBUPROFEN
ORAL SUSPENSION

100 mg/5 mL
200 mg/10 mL
Berry Flavor

For Hospital Use Only

Drug Facts

Active Ingredient (in each 5 mL)

Ibuprofen 100 mg(NSAID)1

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1

nonsteroidal anti-inflammatory drug

Purposes

Pain reliever/Fever reducer

Uses

temporarily:

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

Warnings

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 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 non-prescription)
• 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

• use as directed per healthcare professional
• 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 cups well before using
• if needed, repeat dose every 6 - 8 hours
• do not use more than 4 times a day

Other Information

• store at 20-25°C (68-77°F)
• alcohol free
• See individual label or shipper label for lot number and expiration date.

Inactive Ingredients

anhydrous citric acid, butylparaben, corn syrup, D&C red #33, FD&C yellow #6, flavor, glycerin, hypromellose, polysorbate 80, propylene glycol, purified water, sodium benzoate, sorbitol, xanthan gum

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

Mfg. By: Perrigo
515 Eastern Avenue
Allegan, MI 49010

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

LI587
Rev. 02/09

PRINCIPAL DISPLAY PANEL - Bag

Children's Ibuprofen Oral Suspension

100 mg/5ml

5 Unit Dose Cups

CHILDRENS IBUPROFEN  ibuprofen   suspension

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 55154-1577 (68094-494) Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Ibuprofen (Ibuprofen) Ibuprofen 100 mg  in 5 mL

Inactive Ingredients Ingredient Name Strength anhydrous citric acid   butylparaben   corn syrup   D&C red NO. 33   FD&C yellow NO. 6   glycerin   hypromelloses   polysorbate 80   propylene glycol   water   sodium benzoate   sorbitol   xanthan gum

Product Characteristics Color ORANGE Score      Shape Size Flavor BERRY Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 55154-1577-5 5 CUP In 1 BAG contains a CUP, UNIT-DOSE 1 5 mL In 1 CUP, UNIT-DOSE This package is contained within the BAG (55154-1577-5)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA074937	04/13/2004

Labeler - Cardinal Health (188557102)

Establishment
Name	Address	ID/FEI	Operations
Cardinal Health		188557102	REPACK

Revised: 05/2011Cardinal Health