Childrens Ibuprofen Oral Suspension

Generic name: Ibuprofen

Suspension, USP · PAI Holdings, LLC dba PAI Pharma

Dosage Form

Suspension, USP

Manufacturer

PAI Holdings, LLC dba PAI Pharma

Active ingredient

Ibuprofen100 mg / 5 mL

Important Safety Information

This medication contains important usage instructions, warnings, and side effect information that you should review before use.

Full label on DailyMed PDF Full label (ZIP)

temporarily:

relieves minor aches and pains due to the common cold, flu, sore throat, headache and toothache
reduces fever

take with food or milk if stomach upset occurs

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

What it looks like

Photos of the product and/or packaging supplied by the manufacturer.

Package codes (NDC)

0121-0833-00
0121-0833-05
0121-0833-40
0121-1666-00
0121-1666-10
0121-1666-40

Full prescribing information (for healthcare professionals)

SPL UNCLASSIFIED SECTION

Drug Facts

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.

MANUFACTURED BY

PAI Pharma

Greenville, SC 29605

R04/24

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Active ingredient

Important Safety Information

What this medicine is forThe uses this medicine is approved for.

What this medicine is forOver-the-counter use.

How to take itDosage and administration instructions.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; otherwis…

Do not use if…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)

Ask a doctor before use 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 t…

Ask a doctor or pharmacist before use if…under a doctor's care for any serious condition taking any other drug

Stop use and talk to a doctor if…if the child has ever had an allergic reaction to ibuprofen or any other pain reliever/fever reducer right before or after heart surgery

Storage and handling■ 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 O…

Package labelDelivers 5 mL NDC 0121-833-5 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

Package labelDelivers 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