Drug Facts
Composition & Profile
Identifiers & Packaging
PRINCIPAL DISPLAY PANEL Delivers 5 mL NDC 0121- 0833 -05 CHILDREN'S IBUPROFEN ORAL SUSPENSION, USP (NSAID) 100 mg per 5 mL SHAKE WELL Alcohol Free/Dye Free For Institutional Use Only Dist. by : PAI Pharma Greenville, SC 29605 SEE DRUG FACTS Ibuprofen - 5 mL; PRINCIPAL DISPLAY PANEL Delivers 10 mL NDC 0121- 1666 -10 CHILDREN'S IBUPROFEN ORAL SUSPENSION, USP (NSAID) 200 mg per 10 mL SHAKE WELL Alcohol Free/Dye Free For Institutional Use Only Dist. by: PAI Pharma Greenville, SC 29605 SEE DRUG FACTS Ibuprofen - 10 mL
- PRINCIPAL DISPLAY PANEL Delivers 5 mL NDC 0121- 0833 -05 CHILDREN'S IBUPROFEN ORAL SUSPENSION, USP (NSAID) 100 mg per 5 mL SHAKE WELL Alcohol Free/Dye Free For Institutional Use Only Dist. by : PAI Pharma Greenville, SC 29605 SEE DRUG FACTS Ibuprofen - 5 mL
- PRINCIPAL DISPLAY PANEL Delivers 10 mL NDC 0121- 1666 -10 CHILDREN'S IBUPROFEN ORAL SUSPENSION, USP (NSAID) 200 mg per 10 mL SHAKE WELL Alcohol Free/Dye Free For Institutional Use Only Dist. by: PAI Pharma Greenville, SC 29605 SEE DRUG FACTS Ibuprofen - 10 mL
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. 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 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)
Storage & Handling
Other information ■ each 5 mL contains : sodium 2 mg ■ store between 20° to 25°C (68° to 77°F) ■ do not use if carton is opened or if safety seal under cap printed with “SEALED FOR YOUR PROTECTION” is torn or missing Children’s Ibuprofen Oral Suspension is a white to off-white suspension supplied in the following: NDC 0121-0833-04: 4 fl oz (120 mL) bottle NDC 0121-0833-81: Case contains 12 cartons of NDC 0121-0833-04. NDC 0121-0833-05: 5 mL unit dose cup. NDC 0121-0833-00: Case contains 100 unit dose cups of 5 mL packaged in 10 trays of 10 unit dose cups each. NDC 0121-0833-40: Case contains 40 unit dose cups of 5 mL packaged in 4 trays of 10 unit dose cups each. NDC 0121-1666-10: 10 mL unit dose cup. NDC 0121-1666-00: Case contains 100 unit dose cups of 10 mL packaged in 10 trays of 10 unit dose cups each. NDC 0121-1666-40: Case contains 40 unit dose cups of 10 mL packaged in 4 trays of 10 unit dose cups each.
Questions
Questions or comments? Call 1-800-845-8210.
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