CHILDRENS IBUPROFEN - ibuprofen suspension
Precision Dose Inc.

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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)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
asthma (wheezing)
skin reddening

facial swelling
shock
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

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 - 5 mL Cup Label

NDC 68094-494-59

PrecisionDose™

Children's IBUPROFEN
Oral Suspension
100 mg/5 mL

Pkg: Precision Dose, Inc., S. Beloit, IL 61080

PRINCIPAL DISPLAY PANEL - 5 mL Cup Label

CHILDRENS IBUPROFEN
ibuprofen suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68094-494(NDC:0113-0897)
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
D&C yellow NO. 10
FD&C red NO. 40
glycerin
high fructose corn syrup
hypromelloses
polysorbate 80
water
sodium benzoate
sorbitol
xanthan gum

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

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:68094-494-62	3 TRAY ( TRAY) in 1 CASE	contains a TRAY
1		10 CUP, UNIT-DOSE ( CUP) in 1 TRAY	This package is contained within the CASE (68094-494-62) and contains a CUP, UNIT-DOSE (68094-494-59)
1	NDC:68094-494-59	5 mL in 1 CUP, UNIT-DOSE	This package is contained within a TRAY and a CASE (68094-494-62)
2	NDC:68094-494-61	10 TRAY ( TRAY) in 1 CASE	contains a TRAY
2		10 CUP, UNIT-DOSE ( CUP) in 1 TRAY	This package is contained within the CASE (68094-494-61) and contains a CUP, UNIT-DOSE (68094-494-59)
2	NDC:68094-494-59	5 mL in 1 CUP, UNIT-DOSE	This package is contained within a TRAY and a CASE (68094-494-61)
3	NDC:68094-494-58	5 BAG ( BAG) in 1 CASE	contains a BAG
3		10 SYRINGE ( SYRINGE) in 1 BAG	This package is contained within the CASE (68094-494-58) and contains a SYRINGE
3		5 mL in 1 SYRINGE	This package is contained within a BAG and a CASE (68094-494-58)

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