FDA Label for Childrens Ibuprofen
View Indications, Usage & Precautions
Childrens Ibuprofen Product Label
The following document was submitted to the FDA by the labeler of this product Pai Holdings, Llc Dba Pai Pharma. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient (In Each 5 Ml)
Ibuprofen 100 mg (NSAID)
nonsteroidal anti-inflammatory drug
Purpose
Pain reliever/fever reducer
Uses
temporarily:
- relieves minor aches and pains due to the common cold, flu, sore throat, headache and toothache
- reduces fever
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
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
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 |
Other Information
- each 5 mL contains: sodium 2 mg
- store between 20° to 25°C (68° to 77°F)
Children’s Ibuprofen Oral Suspension is a clear, berry flavored suspension supplied in the following oral dosage forms:
NDC 0121-1022-05: 5 mL unit dose cup, in a tray of ten cups.
Principal Display Panel
Delivers 5 mL
NDC 0121-1022-05
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
* Please review the disclaimer below.