FDA Label for Ibuprofen Junior

Active Ingredient (In Each Tablet)

Ibuprofen 100 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

Uses

temporarily:

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

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

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 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, or kidney disease
• 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

• mouth or throat burning may occur; give with food or water
• 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

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
• 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)

Directions

• this product does not contain directions or complete warnings for adult use
• do not give more than directed
• find the right dose on chart below. 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)	Tablets
under 24	under 2	ask a doctor
24-35	2-3	1
36-47	4-5	1 ½
48-59	6-8	2
60-71	9-10	2 ½
72-95	11	3

Other Information

• phenylketonurics: contains phenylalanine 6 mg per tablet
• do not use if printed seal under cap is broken or missing
• store at 20-25°C (68-77°F)
• see end panel for lot number and expiration date

Inactive Ingredients

acesulfame potassium, ammonium glycerrhizin, aspartame, carnauba wax, croscarmellose sodium, FD&C yellow no. 6 aluminum lake, hypromellose, magnesium stearate, mannitol, natural and artificial flavors, prosweet, silicon dioxide, sodium lauryl sulfate, soybean oil, succinic acid

Questions Or Comments?

1-800-719-9260

Principal Display Panel

junior strength Ibuprofen tablets, 100 mg

Pain Reliever/Fever Reducer (NSAID)

Lasts up to 8 hours

image of package label - 5623

Compare to Motrin® Junior Strength active ingredient

See New Warnings Information

FOR AGES 2 TO 11