Childrens ibuprofen suspension

Drug facts

Active ingredient (in each 5 mL)


Ibuprofen USP 100 mg (NSAID)*

Purpose

Pain reliever/fever reducer

*nonsteroidal anti-inflammatory drug

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
  • 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 ibuprofen or 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 hada stroke
  • child has asthma
  • child is taking a diuretic

Ask a doctor or pharmacist before use ifthe 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

  • 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
  • mL = milliliter
  • find right dose on chart. If possible, use weight to dose; otherwise use age.
  • use only enclosed dosing cup. Do not use any other dosing device.
  • if needed, repeat dose every 6 to 8 hours
  • do not use more than 4 times a day
  • replace original bottle cap to maintain child resistance
  • wash dosage cup after each use

Dosing Chart
* or as directed by a doctor
Weight (lb)
Age (year)
Dose (mL)*
under 24
under 2 years
ask a doctor
24-35 lbs
2-3 years
5 mL
36-47 lbs
4-5 years
7.5 mL
48-59 lbs
6-8 years
10 mL
60-71 lbs
9-10 years
12.5 mL
72-95 lbs
11 years
15 mL

Other information

  • each 5 mL contains:sodium2 mg
  • store between 20 to 25C (68 to 77F)
  • do not use if carton is opened or seal under cap opening is broken or missing
  • see bottom panel for lot number and expiration date

Inactive ingredients

Acesulfame potassium, art raspberry flavor, citric acid anhydrous, D&C yellow No. 10, FD&C red No. 40, glycerin, hypromellose, polysorbate 80, pregelatinized starch (potato), purified water, sodium benzoate, sucrose and xanthan gum

Questions or comments?
Call 1-855-274-4122


Distributed by:
AUROHEALTH LLC
2572 Brunswick Pike
Lawrenceville, NJ 08648

Made in India

Code: TS/DRUGS/19/1993

Ingredients and appearance - Product information

Childrens ibuprofen suspension- Ibuprofen

Product information

Product Type Human OTC Drug Label Item Code (Source) NDC: 58602-200
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Ibuprofen ( UNII: WK2XYI10QM)( Ibuprofen - UNII: WK2XYI10QM ) 100 mgin 5 mL

Inactive Ingredients

Ingredient Name Code
Acesulfame potassium ( UNII: 23OV73Q5G9)
Raspberry ( UNII: 4N14V5R27W)
Anhydrous citric acid ( UNII: XF417D3PSL)
D&c yellow no. 10 ( UNII: 35SW5USQ3G)
Fd&c red no. 40 ( UNII: WZB9127XOA)
Glycerin ( UNII: PDC6A3C0OX)
Hypromellose 2208 (4000 mpa.s) ( UNII: 39J80LT57T)
Polysorbate 80 ( UNII: 6OZP39ZG8H)
Starch, potato ( UNII: 8I089SAH3T)
Water ( UNII: 059QF0KO0R)
Sodium benzoate ( UNII: OJ245FE5EU)
Sucrose ( UNII: C151H8M554)
Xanthan gum ( UNII: TTV12P4NEE)

Product Characteristics

Color ORANGE (Light orange to orange) Flavor BERRY

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA209179 USA

Labeler - Aurohealth LLC( 078728447)

Establishment

Name ID/FEI Business Operations
Aurohealth LLC 078728447 ANALYSIS( 58602-200), MANUFACTURE( 58602-200)

Package label-principal display panel4 fl oz (120 ml) containerlabel

NDC 58602-200-24
For Ages 2 to 11 Years
Childrens
Ibuprofen
Oral Suspension USP
100 mg per 5 mL
Pain Reliever/Fever Reducer (NSAID)
Lasts up to
8 hours
Alcohol Free
Berry Flavor
4 FL OZ (120 mL)
AUROHEALTH


Package label-principal display panel4 fl oz (120 ml) carton label

NDC 58602-200-24
For Ages 2 to 11 Years
Childrens
Ibuprofen
Oral Suspension USP
100 mg per 5 mL
Pain Reliever/Fever Reducer (NSAID)
Lasts up to
8 hours
Alcohol Free
Berry Flavor
4 FL OZ (120 mL)
AUROHEALTH