Childrens Ibuprofen Oral Suspension Dye Free Suspension
FDA Label NDC 81522-311

Drug Facts

Active ingredient (in each 5 mL)

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 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 drug 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 a doctor.

• if the child has ever had an allergic reaction to ibuprofen or 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, kidney disease, or had a stroke
• 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

• child experiences any of the following signs of stomach bleeding:
  • feels faint  
  • vomits blood
  • has bloody or black stool
  • 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

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
• mL = milliliter
• find right dose on chart. if possible, use weight to dose; otherwise use age.
• use only enclosed dosing cup. Do not use any other dosing device.
• 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        

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)
• ​do not use if printed neckband is broken or missing

Acesulfame potassium, anhydrous citric acid, carboxymethylcellulose sodium, flavors, glycerin, microcrystalline cellulose, polysorbate 80, propylene glycol, purified water, sodium benzoate, sucrose, and xanthan gum

Call 1-888-588-1418 from 9 AM to 5 PM ET, Monday-Friday.

NDC 81522-311-11

†Compare to the active ingredient in Children's Motrin^®

FOR AGES 2-11 YEARS

CHILDREN'S IBUPROFEN

100 mg per 5 mL

Oral Suspension, USP (NSAID)

PAIN RELIEVER/FEVER REDUCER

ORIGINAL Berry Flavor

• Dye-Free
• Alcohol-Free

Lasts up to 8 HOURS

 4 FL OZ (118mL)

Important: Read all product information before using. Keep this box for important information.

This product is intended for use in children.

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

Manufactured for FSA Store Inc.

5473 Blair Rd Suite 100

PMB 24308 Dallas, TX 75231



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