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


Uses

temporarily:

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

MANUFACTURED BY

PAI Pharma

Greenville, SC 29605

R04/24

Active ingredient (in each 5 mL)

Ibuprofen 100 mg (NSAID)1

1nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

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)

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 every6-8 hours
• do not use more than4 times a day
• replace original bottle cap to maintain child resistance

• 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)
■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.

Inactive ingredients

avicel, citric acid, glycerin, polysorbate 80, purified water, sodium benzoate, sodium carboxymethylcellulose, sorbitol solution, sucrose, xanthan gum. May contain citric acid and sodium citrate dihydrate for pH adjustment.

Questions or comments?

Call 1-800-845-8210.