CHILDRENS IBUPROFEN IBUPROFEN AUROHEALTH LLC FDA Approved Uses temporarily: relieves minor aches and pains due to the common cold, flu, sore throat, headache and toothache reduces fever
FunFoxMeds bottle
Substance Ibuprofen
Route
ORAL
Applications
ANDA209179

Drug Facts

Composition & Profile

Active Ingredients
Drug Facts Active ingredient (in each 5 mL) Ibuprofen USP 100 mg (NSAID)*
Inactive Ingredients
Inactive ingredients Acesulfame potassium art grape flavor citric acid anhydrous D&C Red No. 33 FD&C blue No. 1 FD&C red No. 40 glycerin hypromellose polysorbate 80 pregelatinized starch (potato) propylene glycol 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
Strengths
5 ml 100 mg
Quantities
120 ml 5 ml
Treats Conditions
Uses Temporarily Relieves Minor Aches And Pains Due To The Common Cold Flu Sore Throat Headache And Toothache Reduces Fever
Pill Appearance
Color: purple

Identifiers & Packaging

Container Type BOTTLE
UNII
WK2XYI10QM
Packaging

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 4 FL OZ (120 mL) Container Label NDC 58602-003-24 For Ages 2 to 11 Years Children’s Ibuprofen Oral Suspension USP 100 mg per 5 mL Pain Reliever/Fever Reducer (NSAID) Lasts up to 8 hours Alcohol Free Grape Flavor 4 FL OZ (120 mL) AUROHEALTH PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 4 FL OZ (120 mL) Container Label; PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 4 FL OZ (120 mL) Carton Label NDC 58602-003-24 # Compare to the active ingredient in Children's Motrin ® For Ages 2 to 11 Years Children’s Ibuprofen Oral Suspension USP 100 mg per 5 mL Pain Reliever/Fever Reducer (NSAID) Lasts up to 8 hours Alcohol Free Grape Flavor 4 FL OZ (120 mL) AUROHEALTH PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 4 FL OZ (120 mL) Carton Label

Package Descriptions
  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 4 FL OZ (120 mL) Container Label NDC 58602-003-24 For Ages 2 to 11 Years Children’s Ibuprofen Oral Suspension USP 100 mg per 5 mL Pain Reliever/Fever Reducer (NSAID) Lasts up to 8 hours Alcohol Free Grape Flavor 4 FL OZ (120 mL) AUROHEALTH PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 4 FL OZ (120 mL) Container Label
  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 4 FL OZ (120 mL) Carton Label NDC 58602-003-24 # Compare to the active ingredient in Children's Motrin ® For Ages 2 to 11 Years Children’s Ibuprofen Oral Suspension USP 100 mg per 5 mL Pain Reliever/Fever Reducer (NSAID) Lasts up to 8 hours Alcohol Free Grape Flavor 4 FL OZ (120 mL) AUROHEALTH PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 4 FL OZ (120 mL) Carton Label

Overview

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

Indications & Usage

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

Dosage & Administration

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

Warnings & Precautions
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.
Purpose

Purpose Pain reliever/fever reducer *nonsteroidal anti-inflammatory drug

Do Not Use

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

When Using

When using this product take with food or milk if stomach upset occurs

Stop Use & Ask a Doctor

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

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)

Storage & Handling

Other information each 5 mL contains : sodium 2 mg store between 20 to 25°C (68 to 77°F) 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


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