DOSAGE & ADMINISTRATION SECTION.

Directions. this product does not contain directions or complete warnings for adult usedo not give more than directedshake well before usingmL milliliterfind right dose on chart. If possible, use weight to dose; otherwise use ageif needed repeat dose every 6-8 hours do not use more than times day Dosing Chart Weight (lb) Age (yr) Dose (mL) under 24 under years ask doctor 24-35 lbs 2-3 years 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 doctor. 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 times day.

INACTIVE INGREDIENT SECTION.

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.

INDICATIONS & USAGE SECTION.

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

OTC - ACTIVE INGREDIENT SECTION.

Active ingredient (in each mL). Ibuprofen 100 mg (NSAID)nonsteroidal anti-inflammatory drug.

OTC - ASK DOCTOR SECTION.

Ask doctor before use if. stomach bleeding warning applies to your childchild has history of stomach problems, such as heartburnchild has problems or serious side effects from taking pain relievers or fever reducerschild has not been drinking fluidschild has lost lot of fluid due to vomiting or diarrheachild has high blood pressure, heart disease, liver cirrhosis, kidney disease, or had strokechild has asthmachild is taking diuretic. stomach bleeding warning applies to your child. child has 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 lot of fluid due to vomiting or diarrhea. child has high blood pressure, heart disease, liver cirrhosis, kidney disease, or had stroke. child has asthma. child is taking diuretic.

OTC - ASK DOCTOR/PHARMACIST SECTION.

Ask doctor or pharmacist before use if the child is. under doctors care for any serious conditiontaking any other drug. under doctors care for any serious condition. taking any other drug.

OTC - DO NOT USE SECTION.

Do not use. if the child has ever had an allergic reaction to Ibuprofen or any other pain reliever/fever reducerright before or after heart surgery. if the child has ever had an allergic reaction to Ibuprofen or any other pain reliever/fever reducer. right before or after heart surgery.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION.

Keep out of reach of children. In case of overdose, get medical help or contact Poison Control Center right away. (1-800-222-1222).

OTC - PURPOSE SECTION.

Purpose. Pain reliever/fever reducer.

OTC - QUESTIONS SECTION.

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

OTC - STOP USE SECTION.

Stop use and ask doctor if. child experiences any of the following signs of stomach bleeding: feels faintvomits bloodhas bloody or black stoolshas stomach pain that does not get better child has symptoms of heart problems or stroke: chest paintrouble breathingweakness in one part or side of bodyslurred speechleg swelling the child does not get any relief within first day (24 hours) of treatmentfever or pain gets worse or lasts more than daysredness or swelling is present in the painful areaany new symptoms appear child experiences any of the following signs of stomach bleeding: feels faintvomits bloodhas bloody or black stoolshas stomach pain that does not get better 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 paintrouble breathingweakness in one part or side of bodyslurred speechleg swelling 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 days. redness or swelling is present in the painful area. any new symptoms appear.

OTC - WHEN USING SECTION.

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

Principal Display Panel. Delivers mL NDC 0121-1022-05Dye Free Childrens IbuprofenOral Suspension, USP(NSAID)100 mg per mLPain Reliever/Fever ReducerBerry Flavored/Dye Free/Alcohol FreeSHAKE WELLPackage Not Child-ResistantPAI PharmaGreenville, SC 29605SEE DRUG FACTS. Childrens Ibuprofen Oral Suspension USP 5mL lidding label.

SPL UNCLASSIFIED SECTION.

Important:. Read all product information before using. Keep this insert for important information. This product is intended for use in children.

WARNINGS SECTION.

Warnings. . Allergy alert: Ibuprofen may cause severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: hivesfacial swellingasthma (wheezing)shockskin reddeningrashblisters 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 problemstakes blood thinning (anticoagulant) or steroid drugtakes other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)takes more or for 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 days or administer to children under years of age unless directed by doctor. hives. facial swelling. asthma (wheezing). shock. skin reddening. rash. blisters has had stomach ulcers or bleeding problems. takes blood thinning (anticoagulant) or steroid drug. takes other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others). takes more or for longer time than directed Do not use. if the child has ever had an allergic reaction to Ibuprofen or any other pain reliever/fever reducerright before or after heart surgery. 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 doctor before use if. stomach bleeding warning applies to your childchild has history of stomach problems, such as heartburnchild has problems or serious side effects from taking pain relievers or fever reducerschild has not been drinking fluidschild has lost lot of fluid due to vomiting or diarrheachild has high blood pressure, heart disease, liver cirrhosis, kidney disease, or had strokechild has asthmachild is taking diuretic. stomach bleeding warning applies to your child. child has 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 lot of fluid due to vomiting or diarrhea. child has high blood pressure, heart disease, liver cirrhosis, kidney disease, or had stroke. child has asthma. child is taking diuretic. Ask doctor or pharmacist before use if the child is. under doctors care for any serious conditiontaking any other drug. under doctors care for any serious condition. taking any other drug. When using this product. take with food or milk if stomach upset occurs. take with food or milk if stomach upset occurs. Stop use and ask doctor if. child experiences any of the following signs of stomach bleeding: feels faintvomits bloodhas bloody or black stoolshas stomach pain that does not get better child has symptoms of heart problems or stroke: chest paintrouble breathingweakness in one part or side of bodyslurred speechleg swelling the child does not get any relief within first day (24 hours) of treatmentfever or pain gets worse or lasts more than daysredness or swelling is present in the painful areaany new symptoms appear child experiences any of the following signs of stomach bleeding: feels faintvomits bloodhas bloody or black stoolshas stomach pain that does not get better 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 paintrouble breathingweakness in one part or side of bodyslurred speechleg swelling 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 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 Poison Control Center right away. (1-800-222-1222).