Dye Free Childrens Ibuprofen

Generic name: Ibuprofen

PAI Holdings, LLC dba PAI Pharma

Dosage Form

N/A

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. 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

What it looks like

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

Package codes (NDC)

0121-1022-00
0121-1022-05
0121-2044-00
0121-2044-10

Full prescribing information (for healthcare professionals)

Important:

Read all product information before using. Keep this insert for important information. This product is intended for use in children.

Drug Facts

SPL UNCLASSIFIED SECTION

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.

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.
NDC 0121-1022-00; Case contains 100 unit dose cups of 5 mL (0121-1022-05) packaged in 10 trays of 10 unit dose cups each.

NDC 0121-2044-10: 10 mL Unit dose cup
NDC 0121-2044-00: Case contains 100 unit dose cups of 10 mL (0121-2044-10) packaged in 10 trays of 10 unit dose cups each.

*All trademarks are property of their respective owners.

This product is not affiliated with the makers/owners of Children's Motrin® Dye-Free Berry Flavor.

PACKAGED BY
PAI Pharma
Greenville, SC 29605

R07/23

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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. If possible, use weight to dose; otherwise use…

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

Package labelDelivers 5 mL NDC 0121-1022-05 Dye Free 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…

Package labelNDC 0121-2044-10 Dye Free Children's Ibuprofen 200 mg per 10 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 Liddi…