CHILDRENS IBUPROFEN- ibuprofen suspension

Childrens Ibuprofen by

Drug Labeling and Warnings

Childrens Ibuprofen by is a Otc medication manufactured, distributed, or labeled by Cardinal Health. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

100 mg/5 mL 200 mg/10 mL

For Hospital Use Only

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient (in each 5 mL = 1 teaspoonful)

Ibuprofen 100 mg (NSAID)1

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, 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:

• 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

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

SPL UNCLASSIFIED SECTION

Alcohol Free, Gluten Free

How Supplied

Available :

Overbagged with 5 cups (10 mL per unit dose cup) per bag, NDC: 55154-1585-5

SPL UNCLASSIFIED SECTION

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

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

Distributed by:

Cardinal Health

Dublin, OH 43017

L49748610318

LI 587
Rev. 04/13

Principal Display Panel

Children’s Ibuprofen Oral Suspension

200 mg/ 10 mL

5 x 10 mL Unit Dose Cups

INGREDIENTS AND APPEARANCE

CHILDRENS IBUPROFEN 
ibuprofen suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55154-1585(NDC:68094-503)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Ibuprofen (UNII: WK2XYI10QM) (Ibuprofen - UNII:WK2XYI10QM)	Ibuprofen	200 mg  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
anhydrous citric acid (UNII: XF417D3PSL)
D&C yellow NO. 10 (UNII: 35SW5USQ3G)
FD&C red NO. 40 (UNII: WZB9127XOA)
glycerin (UNII: PDC6A3C0OX)
high fructose corn syrup (UNII: XY6UN3QB6S)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
polysorbate 80 (UNII: 6OZP39ZG8H)
water (UNII: 059QF0KO0R)
sodium benzoate (UNII: OJ245FE5EU)
sorbitol (UNII: 506T60A25R)
xanthan gum (UNII: TTV12P4NEE)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55154-1585-5	10 in 1 BAG	09/14/2006
1		10 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA074937	09/14/2006

Labeler - Cardinal Health (603638201)