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Infants Ibuprofen by Actavis Inc.

Dosage form: suspension
Ingredients: IBUPROFEN 50mg in 1.25mL
Labeler: Actavis Inc.
NDC Code: 45963-125

Infants’ Ibuprofen Concentrated Oral Suspension, USP

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 a NSAID, which may cause severe stomach bleeding. The chance is higher if the 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 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 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
  • 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
  • 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 below.  If possible, use weight to dose; otherwise use age.
  • 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 mosask a doctor
12 to 17 lbs6 to 11 mos1.25 mL
18 to 23 lbs12 to 23 mos1.875 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
  • see bottom panel for lot number and expiration date

INACTIVE INGREDIENTS

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

QUESTIONS OR COMMENTS?

1-800-432-8534 Monday  through Friday 9 am to 4 pm EST.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

See New Warnings Information

Compare to the active ingredient in Concentrated Motrin( Infants’ Drops*

NDC 45963-125-24

For Ages 6 Mos. to 23 Mos.

Infants’ Ibuprofen

Concentrated Ibuprofen Oral Suspension, USP

(NSAID)

Pain Reliever

Fever Reducer

50 mg/1.25 mL

Lasts up to 8 hours

Use only with enclosed syringe

Non-Staining

Berry Flavor

Dye-Free

Alcohol Free

1 FL OZ (30 mL)

BERRY FLAVOR CARTON LABEL

INFANTS IBUPROFEN 
concetrated ibuprofen suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45963-125
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 
ANHYDROUS CITRIC ACID 
GLYCERIN 
CELLULOSE, MICROCRYSTALLINE 
POLYSORBATE 80 
WATER 
SODIUM BENZOATE 
SUCROSE 
XANTHAN GUM 
Product Characteristics
ColorWHITE (white to off-white) Score    
ShapeSize
FlavorBERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:45963-125-241 BOTTLE (BOTTLE) in 1 CARTON
130 mL in 1 BOTTLE
2NDC:45963-125-231 BOTTLE (BOTTLE) in 1 CARTON
215 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07905805/20/2010
Labeler - Actavis Inc. (099262404)

Revised: 07/2011
 
Actavis Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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