Dye Free Childrens Ibuprofen Suspension
FDA Label NDC 0121-1022

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Pai Holdings, Llc Dba Pai Pharma for the product Dye Free Childrens Ibuprofen (NDC 0121-1022). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient (in each 5 ml), purpose, uses, do not use, ask a doctor before use if, ask a doctor or pharmacist before use if the child is, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Active Ingredient (in Each 5 Ml)

→ Purpose

→ Uses

→ Do Not Use

→ Ask A Doctor Before Use If

→ Ask A Doctor Or Pharmacist Before Use If The Child Is

→ When Using This Product

→ Stop Use And Ask A Doctor If

→ Directions

→ Other Information

→ Principal Display Panel

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

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