Childrens Ibuprofen IBUPROFEN RITE AID CORPORATION FDA Approved Uses temporarily: • relieves minor aches and pains due to the common cold, flu, sore throat, headache and toothache • reduces fever
FunFoxMeds box
Substance Ibuprofen
Route
ORAL
Applications
ANDA074937

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient (in each 5 mL) Ibuprofen 100 mg (NSAID)* *nonsteroidal anti-inflammatory drug
Inactive Ingredients
Inactive ingredients anhydrous citric acid FD&C red #40 glycerin high fructose corn syrup hypromellose natural and artificial bubblegum flavors polysorbate 80 purified water sodium benzoate sorbitol solution xanthan gum
Strengths
5 ml 100 mg
Quantities
5 ml 120 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: pink

Identifiers & Packaging

Container Type BOX
UNII
WK2XYI10QM
Packaging

Principal Display Panel Compare to the active ingredient in Children’s Motrin® FREE FROM | GLUTEN FREE | ALCOHOL FREE FOR AGES 2 to 11 YEARS CHILDREN’S IBUPROFEN ORAL SUSPENSION 100 mg per 5 mL PAIN RELIEVER FEVER REDUCER (NSAID) lasts up to 8 hours BUBBLEGUM FLAVOR DOSAGE CUP INCLUDED 4 FL OZ (120 mL) RITE AID CHILDREN'S IBUPROFEN BUBBLEGUM CARTON IMAGE

Package Descriptions
  • Principal Display Panel Compare to the active ingredient in Children’s Motrin® FREE FROM | GLUTEN FREE | ALCOHOL FREE FOR AGES 2 to 11 YEARS CHILDREN’S IBUPROFEN ORAL SUSPENSION 100 mg per 5 mL PAIN RELIEVER FEVER REDUCER (NSAID) lasts up to 8 hours BUBBLEGUM FLAVOR DOSAGE CUP INCLUDED 4 FL OZ (120 mL) RITE AID CHILDREN'S IBUPROFEN BUBBLEGUM CARTON IMAGE

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 6-8 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 Weight (lb) Age (yr) Dose (mL)** under 24 lbs 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 ** or as directed by a doctor

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. 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 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 had a stroke • child has asthma • 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 • give 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)
Purpose

Purposes Pain reliever/fever reducer

Do Not Use

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

When Using

When using this product • give 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 • do not use if printed neckband is broken or missing • store at 20-25°C (68-77°F) • do not freeze

Questions

Questions or comments? 1-800-719-9260


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