Childrens Ibuprofen

Chain Drug Marketing Association Inc.

Childrens Ibuprofen Oral Suspension

FULL PRESCRIBING INFORMATION

Drug Facts

Ibuprofen, USP 100 mg (NSAID)**
**nonsteroidal anti-inflammatory drug

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
• shock
• asthma (wheezing)
• rash
• skin reddening
• blisters
• facial swelling

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.

• if the child has ever had an allergic reaction to any other pain reliever/fever reducer
• right before or after heart surgery

• 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

• 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

• 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

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.  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

                                                      Dosing Chart

• each teaspoon contains: sodium 2 mg
• do not use if printed neckband is broken or missing
• store between 20 - 25°C (68 - 77°F)
• see bottom panel for lot number and expiration date

Original Berry flavor: citric acid, D&C yellow #10, FD&C red #40, flavors, glycerin, hypromellose, polysorbate-80, purified water, sodium benzoate, sucrose, xanthan gum

Grape flavor: citric acid, D&C red #33, FD&C blue #1, FD&C red #40, flavors, glycerin, hypromellose, polysorbate-80, purified water, sodium benzoate, sucrose, xanthan gum

Bubble gum flavor: artificial bubble gum flavor, citric acid, FD&C red #40, glycerin, hypromellose, polysorbate-80, purified water, sodium benzoate, sucrose, xanthan gum

1-800-432-8534 between 9 am and 4 pm EST, Monday – Friday.

Quality Choice^®
NDC 63868-756-18
*Compare to the active ingredient in CHILDREN’S MOTRIN^® BERRY
For Ages 2 to 11
Children’s
Ibuprofen
Oral Suspension, USP
(NSAID)
100 mg per 5 mL (teaspoon)
Pain Reliever
Fever Reducer
Lasts up to 8 hours
Alcohol Free
Shake Well Before Using
Original Berry Flavor
4 fl oz (118 mL)

Quality Choice^®
NDC 63868-741-18
*Compare to the active ingredient in CHILDREN’S MOTRIN^® GRAPE
For Ages 2 to 11
Children’s
Ibuprofen
Oral Suspension, USP
(NSAID)
100 mg per 5 mL (teaspoon)
Pain Reliever
Fever Reducer
Lasts up to 8 hours
Alcohol Free
Shake Well Before Using
Grape Flavor
4 fl oz (118 mL)

Quality Choice®
NDC 63868-758-18
*Compare to the active ingredient in CHILDREN’S MOTRIN^® BUBBLE GUM
For Ages 2 to 11
Children’s
Ibuprofen
Oral Suspension, USP
(NSAID)
100 mg per 5 mL (teaspoon)
Pain Reliever
Fever Reducer
Lasts up to 8 hours
Alcohol Free
Shake Well Before Using
Bubble Gum Flavor
4 fl oz (118 mL)