Infants Ibuprofen description, usages, side effects, indications, overdosage, supplying and lots more!

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Infants Ibuprofen

Actavis Inc.




FULL PRESCRIBING INFORMATION

(in each 1.25 mL)

Ibuprofen 50 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Pain reliever/fever reducer

temporarily:

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

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.

  • if the child has ever had an allergic reaction to any other pain reliever/fever reducer
  • right before or after heart surgery
  • 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
  • under a doctor’s care for any serious condition
  • taking any other drug
  • 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
  • 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

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

  • 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 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
  • see bottom panel for lot number and expiration date

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.

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

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)

Infants Ibuprofen BERRY FLAVOR CARTON LABEL

Infants Ibuprofen

concetrated ibuprofen SUSPENSION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:45963-125
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
IBUPROFEN IBUPROFEN 50 mg

Inactive Ingredients

Ingredient Name Strength
CARBOXYMETHYLCELLULOSE SODIUM
ANHYDROUS CITRIC ACID
GLYCERIN
cellulose, microcrystalline
polysorbate 80
water
SODIUM BENZOATE
SUCROSE
XANTHAN GUM

Product Characteristics

Color
WHITE (white to off-white)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 30 in 1 BOTTLE
2 15 in 1 BOTTLE
3 NDC:45963-125-23 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079058 2010-05-20


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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