Ibuprofen

Amneal Pharmaceuticals
Amneal Pharmaceuticals

FULL PRESCRIBING INFORMATION

Active Ingredient                               

(in each 5 mL = 1 teaspoon)

Ibuprofen 100 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/ fever reducer

Temporarily:

• ■ Relieves minor aches and pains due to the common cold, flu, sore throat, headache and toothache

• ■ Reduces fever

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 nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomach bleeding. The chances are higher if your child:

• ■ has had stomach ulcers or bleeding problems

• ■ takes a blood thinning (anticoagulant) or steroid drug

• ■ takes other drugs containing an NSAID (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

• ■ child has problems or serious side effects from taking pain relievers or fever reducers

• ■ 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 has asthma

• ■ child is taking a diuretic

• ■ under 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

• ■ 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 the 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)

• ■ 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)

• ■ use only enclosed measuring cup

• ■ 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

• ■ each teaspoon contains: sodium 2 mg

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

• ■ do not use if bottle wrap, or imprinted foil inner seal is broken or missing

• ■ see bottom panel for lot number and expiration date

acesulfame-potassium, anhydrous citric acid, D&C yellow # 10, FD&C red # 40, glycerin, NA bubble gum flavor FQ5511, polysorbate 80 (tween 80), purified water, sodium benzoate, sucrose, xanthan gum

Questions or Comments? Call 1-877-835-5472,

Monday through Friday 9AM - 5PM EST.

Keep the carton.

It contains important information.

See end panel for expiration date.

*This product is not manufactured or distributed by McNeil-PPC, Inc., distributor of Children’s Motrin^®.

Distributed by: Amneal Pharmaceuticals

Glasgow, KY 42141

Rev. 07-2011