CHILDRENS Ibuprofen IBUPROFEN KESIN PHARMA CORPORATION FDA Approved Uses Temporarily: relieves minor aches and pains due to the common cold, flu, sore throat, headache and toothache reduces fever

Drug Facts

Composition & Profile

Active Ingredients
Drug Facts Active ingredient (in each 5 mL)………………….………………………………..………..Purpose Ibuprofen 100 mg (NSAID)*……………………………………………………………….....…Pain reliever/Fever reducer *nonsteroidal anti-inflammatory drug
Inactive Ingredients
Inactive ingredients anhydrous citric acid artificial mixed berry flavor glycerin high fructose corn syrup hypromellose polysorbate 80 purified water sodium benzoate sorbitol solution xanthan gum
Strengths
5 ml 100 mg
Quantities
5 ml 10 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: white

Identifiers & Packaging

Container Type UNKNOWN
UNII
WK2XYI10QM
Packaging

Principal Display Panel NDC: 81033-019-01 CHLIDREN'S Ibuprofen Oral Suspension, USP 100 mg per 5 mL Delivers 5 mL Case = 100 UD Cups (Do Not Break Case) CHILDREN'S Ibuprofen Case Label; NDC: 81033-019-02 CHILDREN'S Ibuprofen Oral Suspension, USP 200 mg per 10 mL Delivers 10 mL Case = 100 UD Cups (Do Not Break Case) CHILDREN'S Ibuprofen Case Label

Package Descriptions
  • Principal Display Panel NDC: 81033-019-01 CHLIDREN'S Ibuprofen Oral Suspension, USP 100 mg per 5 mL Delivers 5 mL Case = 100 UD Cups (Do Not Break Case) CHILDREN'S Ibuprofen Case Label
  • NDC: 81033-019-02 CHILDREN'S Ibuprofen Oral Suspension, USP 200 mg per 10 mL Delivers 10 mL Case = 100 UD Cups (Do Not Break Case) CHILDREN'S Ibuprofen Case 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 below. If possible, use weight to dose; otherwise use age. if needed, repeat dose every 6 to 8 hours do not use more than 4 times a day Dosing Chart Weight (lb) Age (yr) Dose (mL) under 24 under 2 years ask a doctor 24 to 35 lbs 2 to 3 years 5 mL 36 to 47 lbs 4 to 5 years 7.5 mL 48 to 59 lbs 6 to 8 years 10 mL 60 to 71 lbs 9 to 10 years 12.5 mL 72 to 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 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 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 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)
Purpose

Purpose Pain reliever/Fever reducer

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 at 20°C to 25°C (68°F to 77°F) CHILDREN’S Ibuprofen Oral Suspension is a white, berry flavored suspension supplied in the following oral dosage forms: NDC 81033-019-05: 5 mL unit-dose cup NDC 81033-019-01: Case containing 100 unit-dose cups of 5 mL each. NDC 81033-019-10: 10 mL unit-dose cup NDC 81033-019-02: Case containing 100 unit-dose cups of 10 mL each.

Questions

Questions or comments? Call 1-833-537-4679


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