Leader Ibuprofen Childrens Ibuprofen IBUPROFEN IBUPROFEN ANHYDROUS CITRIC ACID D&C RED NO. 33 FD&C BLUE NO. 1 FD&C RED NO. 40 GLYCERIN HIGH FRUCTOSE CORN SYRUP HYPROMELLOSES POLYSORBATE 80 WATER SODIUM BENZOATE SORBITOL XANTHAN GUM Uses temporarily: • relieves minor aches and pains due to the common cold, flu, sore throat, headache and toothache • reduces fever

Leader Ibuprofen Childrens Ibuprofen IBUPROFEN IBUPROFEN ANHYDROUS CITRIC ACID D&C RED NO. 33 FD&C BLUE NO. 1 FD&C RED NO. 40 GLYCERIN HIGH FRUCTOSE CORN SYRUP HYPROMELLOSES POLYSORBATE 80 WATER SODIUM BENZOATE SORBITOL XANTHAN GUM

Mfr: OTC
FunFoxMeds box

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient (in each 5 mL = 1 teaspoonful) Ibuprofen 100 mg (NSAID)* *nonsteroidal anti-inflammatory drug
Inactive Ingredients
Inactive ingredients anhydrous citric acid D&C red #33 FD&C blue #1 FD&C red #40 glycerin high fructose corn syrup hypromellose natural and artificial grape flavor 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

Identifiers & Packaging

Container Type UNKNOWN
Packaging

Principal Display Panel Compare to Children’s Motrin® active ingredient 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 Grape Flavor Alcohol Free 4 FL OZ (120 mL) Leader Children'sIbuprofen image

Package Descriptions
  • Principal Display Panel Compare to Children’s Motrin® active ingredient 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 Grape Flavor Alcohol Free 4 FL OZ (120 mL) Leader Children'sIbuprofen 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; tsp = teaspoonful • 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 or tsp)** under 24 lbs under 2 years ask a doctor 24-35 lbs 2-3 years 5 mL (1 tsp) 36-47 lbs 4-5 years 7.5 mL (1½ tsp) 48-59 lbs 6-8 years 10 mL (2 tsp) 60-71 lbs 9-10 years 12.5 mL (2½ tsp) 72-95 lbs 11 years 15 mL (3 tsp) **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 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, or kidney disease • 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 • the risk of heart attack or stroke may increase if you use more than directed or for longer than directed 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 • 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 • the risk of heart attack or stroke may increase if you use more than directed or for longer than directed

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 • 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 (1 tsp) 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 • see bottom panel for lot number and expiration date

Questions

Questions or comments? 1-800-719-9260


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