Dye Free Childrens Ibuprofen IBUPROFEN PAI HOLDINGS, LLC DBA PAI PHARMA FDA Approved Uses temporarily: relieves minor aches and pains due to the common cold, flu, sore throat, headache and toothache reduces fever
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Substance Ibuprofen
Route
ORAL
Applications
ANDA210602

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient (in each 5 mL) Ibuprofen 100 mg (NSAID) nonsteroidal anti-inflammatory drug
Inactive Ingredients
Inactive ingredients: Acesulfame potassium anhydrous citric acid carboxymethylcellulose sodium flavors glycerin microcrystalline cellulose polysorbate 80 propylene glycol purified water sodium benzoate sucrose and 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: orange

Identifiers & Packaging

Container Type UNKNOWN
UNII
WK2XYI10QM
Packaging

Principal Display Panel Delivers 5 mL NDC 0121-1022-05 Dye Free Children's Ibuprofen Oral Suspension, USP (NSAID) 100 mg per 5 mL Pain Reliever/Fever Reducer Berry Flavored/Dye Free/Alcohol Free SHAKE WELL Package Not Child-Resistant PAI Pharma Greenville, SC 29605 SEE DRUG FACTS Children's Ibuprofen Oral Suspension USP - 5mL lidding label; Principal Display Panel NDC 0121-2044-10 Dye Free Children's Ibuprofen 200 mg per 10 mL Pain Reliever/Fever Reducer Berry Flavored/Dye Free/Alcohol Free SHAKE WELL Package Not Child-Resistant PAI Pharma Greenville, SC 29605 SEE DRUG FACTS Lidding Children's Ibuprofen Oral Suspension 200 mg per 10 mL - Lidding

Package Descriptions
  • Principal Display Panel Delivers 5 mL NDC 0121-1022-05 Dye Free Children's Ibuprofen Oral Suspension, USP (NSAID) 100 mg per 5 mL Pain Reliever/Fever Reducer Berry Flavored/Dye Free/Alcohol Free SHAKE WELL Package Not Child-Resistant PAI Pharma Greenville, SC 29605 SEE DRUG FACTS Children's Ibuprofen Oral Suspension USP - 5mL lidding label
  • Principal Display Panel NDC 0121-2044-10 Dye Free Children's Ibuprofen 200 mg per 10 mL Pain Reliever/Fever Reducer Berry Flavored/Dye Free/Alcohol Free SHAKE WELL Package Not Child-Resistant PAI Pharma Greenville, SC 29605 SEE DRUG FACTS Lidding Children's Ibuprofen Oral Suspension 200 mg per 10 mL - Lidding

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 if needed repeat dose every 6–8 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 24-35 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 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)

Questions

Questions or comments? Call 1-800-845-8210.


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