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Childrens Ibuprofen by Chain Drug Marketing Association Inc.

Dosage form: suspension
Ingredients: IBUPROFEN 100mg in 5mL
Labeler: Chain Drug Marketing Association Inc.
NDC Code: 63868-756

Ibuprofen Oral Suspension, USP

Drug Facts

Active ingredient (in each 5 mL = 1 teaspoon)

Ibuprofen, USP 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
  • shock
  • asthma (wheezing)
  • rash
  • skin reddening
  • blisters
  • facial swelling

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
  • take 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 the 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
  • this product does not contain directions or complete warnings for adult use
  • do not give more than directed
  • shake well before using
  • find right dose on chart.  If possible, use weight to dose; otherwise use age.
  • use only 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

                                                      Dosing Chart

Weight (lb)

Age (yr)

Dose (tsp 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
  • each teaspoon contains: sodium 2 mg
  • do not use if printed neckband is broken or missing
  • store between 20 - 25°C (68 - 77°F)
  • see bottom panel for lot number and expiration date

Inactive ingredients

Original Berry flavor: citric acid, D&C yellow #10, FD&C red #40, flavors, glycerin, hypromellose, polysorbate-80, purified water, sodium benzoate, sucrose, xanthan gum

 

Dye free berry flavor: citric acid, flavors, glycerin, hypromellose, polysorbate-80, purified water, sodium benzoate, sucrose, xanthan gum

 

Grape flavor: citric acid, D&C red #33, FD&C blue #1, FD&C red #40, flavors, glycerin, hypromellose, polysorbate-80, purified water, sodium benzoate, sucrose, xanthan gum

 

Bubble gum flavor: artificial bubble gum flavor, citric acid, FD&C red #40, glycerin, hypromellose, polysorbate-80, purified water, sodium benzoate, sucrose, xanthan gum

Questions?

1-800-432-8534 between 9 am and 4 pm EST, Monday – Friday.

PRINCIPAL DISPLAY PANEL – ORIGINAL BERRY FLAVOR

Quality Choice®
NDC 63868-756-18
*Compare to the active ingredient in CHILDREN’S MOTRIN® BERRY
For Ages 2 to 11
Children’s
Ibuprofen
Oral Suspension, USP
(NSAID)
100 mg per 5 mL (teaspoon)
Pain Reliever
Fever Reducer
Lasts up to 8 hours
Alcohol Free
Shake Well Before Using
Original Berry Flavor
4 fl oz (118 mL)

PRINCIPAL DISPLAY PANEL – DYE-FREE BERRY

Quality Choice®
NDC 63868-774-04
*Compare to the active ingredient in CHILDREN’S MOTRIN® DYE-FREE BERRY
For Ages 2 to 11
Children’s
Ibuprofen
Oral Suspension, USP
(NSAID)
100 mg per 5 mL (teaspoon)
Pain Reliever
Fever Reducer
Lasts up to 8 hours
Alcohol Free
Non-Staining
Shake Well Before Using
Berry Flavor
Dye-Free
4 fl oz (118 mL)

 

PRINCIPAL DISPLAY PANEL – GRAPE

Quality Choice®
NDC 63868-741-18
*Compare to the active ingredient in CHILDREN’S MOTRIN® GRAPE
For Ages 2 to 11
Children’s
Ibuprofen
Oral Suspension, USP
(NSAID)
100 mg per 5 mL (teaspoon)
Pain Reliever
Fever Reducer
Lasts up to 8 hours
Alcohol Free
Shake Well Before Using
Grape Flavor
4 fl oz (118 mL)

PRINCIPAL DISPLAY PANEL – BUBBLE GUM

Quality Choice®
NDC 63868-758-18
*Compare to the active ingredient in CHILDREN’S MOTRIN® BUBBLE GUM
For Ages 2 to 11
Children’s
Ibuprofen
Oral Suspension, USP
(NSAID)
100 mg per 5 mL (teaspoon)
Pain Reliever
Fever Reducer
Lasts up to 8 hours
Alcohol Free
Shake Well Before Using
Bubble Gum Flavor
4 fl oz (118 mL)

CHILDRENS IBUPROFEN 
ibuprofen suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-756
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 
D&C YELLOW NO. 10 
FD&C RED NO. 40 
GLYCERIN 
HYPROMELLOSE 2910 (4000 MPA.S) 
POLYSORBATE 80 
WATER 
SODIUM BENZOATE 
SUCROSE 
XANTHAN GUM 
Product Characteristics
ColorORANGEScore    
ShapeSize
FlavorBERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:63868-756-181 BOTTLE in 1 CARTON
1118 mL in 1 BOTTLE
2NDC:63868-756-371 BOTTLE in 1 CARTON
2237 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07491610/09/2006
CHILDRENS IBUPROFEN 
ibuprofen suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-774
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 
HYPROMELLOSE 2910 (4000 MPA.S) 
POLYSORBATE 80 
WATER 
SODIUM BENZOATE 
SUCROSE 
XANTHAN GUM 
Product Characteristics
Color    Score    
ShapeSize
FlavorBERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:63868-774-041 BOTTLE in 1 CARTON
1118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07491610/10/2014
CHILDRENS IBUPROFEN 
ibuprofen suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-741
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 
D&C RED NO. 33 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
GLYCERIN 
HYPROMELLOSE 2910 (4000 MPA.S) 
POLYSORBATE 80 
WATER 
SODIUM BENZOATE 
SUCROSE 
XANTHAN GUM 
Product Characteristics
ColorPURPLEScore    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:63868-741-181 BOTTLE in 1 CARTON
1118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07491603/04/2010
CHILDRENS IBUPROFEN 
ibuprofen suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-758
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 
FD&C RED NO. 40 
GLYCERIN 
HYPROMELLOSE 2910 (4000 MPA.S) 
POLYSORBATE 80 
WATER 
SODIUM BENZOATE 
SUCROSE 
XANTHAN GUM 
Product Characteristics
ColorPINKScore    
ShapeSize
FlavorBUBBLE GUMImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:63868-758-181 BOTTLE in 1 CARTON
1118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07491601/10/2008
Labeler - Chain Drug Marketing Association Inc. (011920774)
Registrant - Teva Pharmaceuticals USA, Inc. (001627975)

 
Chain Drug Marketing Association Inc.

← See all Childrens Ibuprofen brands

Medically reviewed on Dec 28, 2017

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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