Childrens Ibuprofen Oral Suspension

Drug Facts

Ibuprofen 100 mg (NSAID)**…………………………………… Pain reliever/fever reducer **nonsteroidal anti-inflammatory drug

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 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

Label information

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

• 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. 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)	Dose (mL)*
under 24	under 2 years	ask a doctor
24-35 lbs	2-3 years	5 mL
36-47 lbs	4-5 years	7.5 mL
48-59 lbs	6-8 years	10 mL
60-71 lbs	9-10 years	12.5 mL
72-95 lbs	11 years	15 mL

*or as directed by a doctor

• each 5 mL contains: sodium 2 mg
• store between 20 to 25°C (68 to 77°F)

Children's Ibuprofen Oral Suspension is purple, grape flavored suspension supplied in the following oral dosage forms:

NDC 0121-0914-05: 5 mL unit dose cup
NDC 0121-0914-00: Case contains 100 unit dose cups of 5 mL (0121-0914-05), packaged in 10 trays of 10 unit dose cups each
NDC 0121-1828-10: 10 mL unit dose cup
NDC 0121-1828-00: Case contains 100 unit dose cups of 10 mL (0121-1828-10) packaged in 10 trays of 10 unit dose cups each

acesulfame potassium, artificial grape flavor, citric acid anhydrous, D&C red #33, FD&C blue #1, FD&C red #40, glycerin, polysorbate 80, pregelatinized corn starch, purified water, sodium benzoate, sucrose, xanthan gum.

Call 1-800-845-8210.

†This product is not manufactured or distributed by McNeil Consumer
Healthcare, distributor of Children’s Motrin®

Delivers 5 mL

NDC 0121-0914-05

Children's Ibuprofen Oral Suspension, USP

(NSAID)

100 mg per 5 mL

Pain reliever/Fever reducer

Grape Flavored/Alcohol Free

SHAKE WELL

Package Not Child-Resistant

Pkg. by: Pharmaceutical Associates, Inc.

Greenville, SC 29680

[Image in the official label — see DailyMed source]

Delivers 10 mL

NDC 0121-1828-10

Children's Ibuprofen Oral Suspension, USP

(NSAID)

200 mg per 10 mL

Pain reliever/Fever reducer

Grape Flavored/Alcohol Free

SHAKE WELL

Package Not Child-Resistant

Pkg. by: Pharmaceutical Associates, Inc.

Greenville, SC 29680

[Image in the official label — see DailyMed source]