DG HEALTH CHILDRENS IBUPROFEN - ibuprofen suspension 
Dolgencorp Inc

----------

Dolgencorp, LLC Children's Ibuprofen Oral Suspension Drug Facts

Active ingredient (in each 5 mL = 1 teaspoonful)

Ibuprofen 100 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

Uses

temporarily:

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

Warnings

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

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

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 nonprescription)
• 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

• 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 well before using
• find right dose on chart below. If possible, use weight to dose; otherwise use age.
• use only with enclosed measuring cup
• if needed, repeat dose every 6-8 hours
• do not use more than 4 times a day
• replace original bottle cap to maintain child resistance
• wash dosage cup after each use

Dosing Chart
Weight (lb)	Age(yrs)	Dose (teaspoonful or mL)
under 2 years		ask a doctor
24-35 lbs	2-3 years	1 tsp or 5 mL
36-47 lbs	4-5 years	1 ½ tsp or 7.5 mL
48-59 lbs	6-8 years	2 tsp or 10 mL
60-71 lbs	9-10 years	2 ½ tsp or 12.5 mL
72-95 lbs	11 years	3 tsp or 15 mL

Other information

• do not use if printed neckband is broken or missing
• store at 20-25°C (68-77°F)
• see bottom panel 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

Questions or comments?

1-888-309-9030

Principal Display Panel

For Ages 2 to 11

Children’s

Ibuprofen Oral Suspension

100 mg per 5 mL (teaspoonful)

Pain Reliever/Fever Reducer (NSAID)

Compare to active ingredient of Children’s Motrin® Berry Flavor

Lasts Up to 8 Hours

Alcohol Free

Temporarily reduces fever and relieves minor aches and pains

Berry flavor

DG HEALTH CHILDRENS IBUPROFEN  ibuprofen   suspension

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 55910-897 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 No Inactive Ingredients Found

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

Packaging # NDC Package Description Multilevel Packaging 1 55910-897-26 1 BOTTLE In 1 CARTON contains a BOTTLE 1 118 mL In 1 BOTTLE This package is contained within the CARTON (55910-897-26)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA074937	03/01/2000

Labeler - Dolgencorp Inc (068331990)

Revised: 11/2009Dolgencorp Inc