IBUPROFEN - ibuprofen suspension 
H.J. Harkins Company, Inc.

----------

Major Pharmaceuticals 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:

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 (lb)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

Questions or comments?


1-800-719-9260


Relabeled by:

H.J. Harkins Company, Inc.

Nipomo, CA 93444

Principal Display Panel

For Ages 2 to 11

Children’s Ibuprofen Oral Suspension

100 mg per 5 mL (teaspoonful)

Pain Reliever

Fever Reducer (NSAID)

Lasts up to 8 hours

See New Warnings Information

Berry Flavored Liquid

Alcohol Free

Children's

COMPARE TO the active ingredient of CHILDREN'S MOTRIN®

Children's Ibuprofen Oral Suspension Carton Image 1

Children's Ibuprofen Oral Suspension Carton Image 1

IBUPROFEN 
ibuprofen suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52959-298(NDC:0904-5309)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN100 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SORBITOL (UNII: 506T60A25R)  
XANTHAN GUM (UNII: TTV12P4NEE)  
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
Product Characteristics
ColorORANGEScore    
ShapeSize
FlavorBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52959-298-041 in 1 CARTON
1240 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07493702/07/1999
Labeler - H.J. Harkins Company, Inc. (147681894)
Registrant - H.J. Harkins Company, Inc. (147681894)
Establishment
NameAddressID/FEIBusiness Operations
H.J. Harkins Company, Inc.147681894repack, relabel

Revised: 2/2012
Document Id: f91e8d59-64bf-479c-b56a-f9e55489940d
Set id: d04a5ea0-0acd-4aaf-8d60-a6b08f3c04a8
Version: 1
Effective Time: 20120216
 
H.J. Harkins Company, Inc.