Concentrated Ibuprofen

Tris Phrama Inc
Tris Pharma Inc

Infants’ Concentrated Ibuprofen Oral Suspension, USP

FULL PRESCRIBING INFORMATION

Ibuprofen 50 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Pain reliever/Fever reducer

temporarily:

■ reduces fever

■ relieves minor aches and pains due to the common cold, flu, sore throat, headaches and toothaches

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 a NSAID, which may cause severe stomach bleeding.

The chance is higher if the 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

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.

■ if the child has ever had an allergic reaction to any other pain reliever/fever reducer

■ right before or after heart surgery

Ask a doctor before use if (two bulleted items removed; child has asthma and child has problems and serious side effects etc)

■ stomach bleeding warning applies to your child

■ child has a history of stomach problems, such as heartburn

■ 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, or kidney disease

■ child is taking a diuretic

■ under a doctor’s care for any serious condition

■ taking any other drug

■ take with food or milk if stomach upset occurs

■ the risk of heart attack or stroke may increase if you use more than directed or for longer than directed

■ side effects occur. You may report side effects to FDA at 1-800-FDA-1088.

■ 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

■ 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

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

■ this product does not contain directions or complete warnings for adult use

■ do not give more than directed

■ shake well before using

■ find right dose on chart below. If possible, use weight to dose; otherwise use age.

■ measure with the dosing device provided. Do not use with any other device.

■ dispense liquid slowly into the child’s mouth, toward the inner cheek

■ if needed, repeat dose every 6 to 8 hours

■ do not use more than 4 times a day

Other information

■ store between 20 to 25˚C (68 to 77˚F)

■ do not use if plastic bottle wrap imprinted “sealed for your protection” is broken or missing

■ see bottom panel for lot number and expiration date

carboxymethylcellulose sodium, citric acid anhydrous, glycerin, microcrystalline cellulose, natural and artificial berry fruit punch type flavor, polysorbate 80, purified water, sodium benzoate, sorbitol solution, sucrose, and xanthan gum.

Questions or Comments?

call 1-732-940-0358 Monday through Friday 9AM to 5PM EST.

NDC 27808-007-01

(15 mL)

27808-007-02

(30 mL)