IBUPROFEN CHILDRENS - ibuprofen suspension 
Safeway

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Active ingredient (in each 5 mL = 1 teaspoonful)

Ibuprofen 100 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

Uses

temporarily:

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

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

Dosing Chart
Weight (lbs)Age(yrs)Dose (teaspoonful or mL)
under 2 yearsask a doctor
24-35 lbs2-3 years1 tsp or 5 mL
36-47 lbs4-5 years1 ½ tsp or 7.5 mL
48-59 lbs6-8 years2 tsp or 10 mL
60-71 lbs9-10 years2 ½ tsp or 12.5 mL
72-95 lbs11 years3 tsp or 15 mL

Other information

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

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Compare to Children's Motrin® Berry Flavor active ingredient

Children's

For Ages 2 to 11

Ibuprofen Oral Suspension

100 mg per 5 mL (Teaspoonful)

Pain Reliever/Fever Reducer (NSAID)

Lasts Up to 8 Hours

Alcohol Free

Berry Flavored Liquid

SEE NEW WARNINGS INFORMATION

Ibuprofen Oral Suspension Carton Image 1

Ibuprofen Oral Suspension Carton Image 1

Ibuprofen Oral Suspension Carton Image 2

Ibuprofen Oral Suspension Carton Image 2


IBUPROFEN  CHILDRENS
ibuprofen suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-897
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (IBUPROFEN) IBUPROFEN100 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID 
GLYCERIN 
HYPROMELLOSES 
POLYSORBATE 80 
WATER 
SODIUM BENZOATE 
SORBITOL 
XANTHAN GUM 
HIGH FRUCTOSE CORN SYRUP 
D&C YELLOW NO. 10 
FD&C RED NO. 40 
Product Characteristics
ColorORANGEScore    
ShapeSize
FlavorBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:21130-897-261 BOTTLE ( BOTTLE) in 1 CARTONcontains a BOTTLE
1120 mL in 1 BOTTLEThis package is contained within the CARTON (21130-897-26)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07493701/18/1999

Labeler - Safeway (009137209)

Revised: 04/2010 Safeway