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

Childrens Ibuprofen

Valu Merchandisers Company

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
Children’s Ibuprofen Oral Suspension,USP (NSAID) 100 mg per 5 mL (teaspoon)



FULL PRESCRIBING INFORMATION

Drug Facts

Ibuprofen 100 mg (NSAID)*
*nonsteroidal anti-inflammatory drug

Pain reliever/fever reducer

temporarily:

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

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 a nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomach bleeding.

The chances are 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.

  • 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 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
  • 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
  • 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.
  • 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

  • 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

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

1-800-432-8534 (select option # 2) between 9 am and 4 pm EST, Monday – Friday.

Compare to
Active Ingredient
Of Children’s
MOTRIN®*

Best Choice® Brand
Health Care

See New Warnings
Information

For Ages 2 to 11

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

Childrens Ibuprofen

Ibuprofen SUSPENSION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:63941-255
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
IBUPROFEN IBUPROFEN 100 mg

Inactive Ingredients

Ingredient Name Strength
CITRIC ACID MONOHYDRATE
GLYCERIN
HYPROMELLOSES
polysorbate 80
water
SODIUM BENZOATE
SUCROSE
XANTHAN GUM
D&C YELLOW NO. 10
FD&C RED NO. 40

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 118 in 1 BOTTLE
2 NDC:63941-255-94 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074916 2006-10-09


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
Copyright © 2014. drugs-library.com. All rights reserved. Information on drugs-library.com is provided for educational purposes only and is not to be used for medical advice, diagnosis or treatment.
Support info@drugs-library.com.