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Infants Ibuprofen by Wal-Mart Stores Inc

Medically reviewed on November 15, 2017

Dosage form: suspension
Ingredients: IBUPROFEN 50mg in 1.25mL
Labeler: Wal-Mart Stores Inc
NDC Code: 49035-125

Ibuprofen Oral Suspension, USP

Drug Facts

Active ingredient (in each 1.25 mL)

Ibuprofen 50 mg (NSAID)*
*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/Fever reducer

Uses

temporarily:

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

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 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

Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer 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, kidney disease, or had a stroke
  • 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

Stop use and ask a doctor if
  • side effects occur. You may report side effects to FDA at 1-800-FDA-1088.
  • 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
  • child has symptoms of heart problems or stroke:
    • chest pain
    • trouble breathing
    • weakness in one part or side of body
    • slurred speech
    • leg swelling    
  • 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
  • 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 below. If possible, use weight to dose; otherwise use age.
  • mL = milliliter
  • measure with the dosing device provided. Do not use with any other device.
  • dispense liquid slowly into the child's mouth, toward the inner cheek
  • if needed, repeat dose every 6 to 8 hours
  • do not use more than 4 times a day

 

Dosing Chart

Weight (lb)

Age (mos)

Dose (mL)

under 6 mos

ask a doctor

12 to 17 lbs

6 to 11 mos

1.25 mL

18 to 23 lbs

12 to 23 mos

1.875 mL


Other information
  • store between 20° to 25°C (68° to 77°F)
  • do not use if plastic bottle wrap imprinted “sealed for your protection” is broken or missing

Inactive ingredients

carboxymethylcellulose sodium, citric acid anhydrous, glycerin, microcrystalline cellulose, natural and artificial berry fruit punch type flavor, polysorbate 80, purified water, sodium benzoate, sorbitol solution, sucrose, and xanthan gum.

Questions or Comments?

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See New Warnings

NDC 49035-125-23

equate™

Compare to Concentrated
Motrin® Infants’ Drops active ingredient**

For Ages 6 Mos. to 23 Mos.

infants’
IBUPROFEN

Concentrated Ibuprofen
Oral Suspension, USP (NSAID)
50 mg per 1.25 mL

Pain Reliever/Fever Reducer

LASTS UP TO 8 HOURS

  • Alcohol Free
  • Non-Staining

Dye-Free
Berry Flavor

0.5  FL OZ (15 mL)

Use only with enclosed syringe.

INFANTS IBUPROFEN 
ibuprofen suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-125
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (IBUPROFEN) IBUPROFEN50 mg  in 1.25 mL
Inactive Ingredients
Ingredient NameStrength
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM 
ANHYDROUS CITRIC ACID 
GLYCERIN 
MICROCRYSTALLINE CELLULOSE 
POLYSORBATE 80 
WATER 
SODIUM BENZOATE 
SORBITOL 
SUCROSE 
XANTHAN GUM 
Product Characteristics
ColorWHITE (white to off-white) Score    
ShapeSize
FlavorBERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:49035-125-231 BOTTLE in 1 CARTON
115 mL in 1 BOTTLE
2NDC:49035-125-241 BOTTLE in 1 CARTON
230 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07905805/21/2012
Labeler - Wal-Mart Stores Inc (051957769)
Registrant - Teva Pharmaceuticals USA, Inc. (001627975)

 
Wal-Mart Stores Inc

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Further information

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

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