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 age.if needed, repeat dose every 6-8 hours do not use more than times day Dosing ChartWeight (lb)Age (yr)Dose (mL)under 24under yearsask doctor24-35 lbs2-3 years5 mL36-47 lbs4-5 years7.5 mL48-59 lbs6-8 years10 mL60-71 lbs9-10 years12.5 mL72-95 lbs11 years15 mLor 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, artificial grape flavor, citric acid anhydrous, D&C red 33, FD&C blue 1, FD&C red 40, glycerin, polysorbate 80, pregelatinized corn starch, purified water, sodium benzoate, sucrose, 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).......................................... Pain reliever/fever reducer 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 (1-800-222-1222) right away.

OTC - PURPOSE SECTION.


Ibuprofen 100 mg (NSAID).......................................... Pain reliever/fever reducer nonsteroidal anti-inflammatory drug.

OTC - QUESTIONS SECTION.


Questions or comments. Call 1-800-845-8210.+This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Childrens Motrin(R).

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 0121-0914-05Childrens Ibuprofen Oral Suspension, USP(NSAID)100 mg per mLPain reliever/Fever reducerGrape Flavored/Alcohol FreeSHAKE WELLPackage Not Child-ResistantPkg. by: Pharmaceutical Associates, Inc.Greenville, SC 29680. Principal Display Panel.

SPL UNCLASSIFIED SECTION.


Drug Facts.

STORAGE AND HANDLING SECTION.


Other information. each mL contains: sodium mg store between 20 to 25C (68 to 77F)Childrens Ibuprofen Oral Suspension is purple, grape flavored suspension supplied in the following oral dosage forms:NDC 0121-1828-10: 10 mL unit dose cup, in tray of ten cups.. each mL contains: sodium mg store between 20 to 25C (68 to 77F).

WARNINGS SECTION.


Warnings. Allergy alert. Ibuprofen may cause severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:hivesfacial swellingasthma (wheezing)shockskin reddeningrashblistersIf an allergic reaction occurs, stop use and seek medical help right away.. hives. facial swelling. asthma (wheezing). shock. skin reddening. rash. blisters. 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. 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. 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.. 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 (1-800-222-1222) right away.