Ibuprofen Oral Suspension, USP

Drug Labeling and Warnings

Drug Details [pdf]

CHILDRENS IBUPROFEN- ibuprofen suspension 
Valu Merchandisers Company

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Ibuprofen Oral Suspension, USP

Drug Facts


Active ingredient (in each 5 mL = 1 teaspoon)

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
  • 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

citric acid, D&C yellow #10, FD&C red #40, flavors, 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

For Ages 2 to 11

Best Choice® 

COMPARE TO THE ACTIVE INGREDIENT
IN CHILDREN'S MOTRIN®BERRY*

Children’s
Ibuprofen
Oral Suspension, USP (NSAID)
100 mg per 5 mL (teaspoon)

  • Pain Reliever
  • Fever Reducer
  • Lasts up to 8 hours

ORIGINAL BERRY FLAVOR
Shake Well
Before Using

Alcohol Free
4 FL OZ (118 mL)

Ibuprofen Childrens OS - original berry
CHILDRENS IBUPROFEN 
ibuprofen suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 63941-255
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)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYPROMELLOSE 2910 (4000 MPA.S) (UNII: RN3152OP35)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SUCROSE (UNII: C151H8M554)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Other Ingredients
Ingredient KindIngredient NameQuantity
Does not containALCOHOL (UNII: 3K9958V90M) 0   in 5 mL
Product Characteristics
Color    Score    
ShapeSize
FlavorBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 63941-255-941 in 1 CARTON10/09/200608/31/2019
1118 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07491610/09/200608/31/2019
Labeler - Valu Merchandisers Company (868703513)
Registrant - Teva Pharmaceuticals USA, Inc. (001627975)

Revised: 12/2017