FDA Label for Childrens Ibuprofen Oral Suspension
View Indications, Usage & Precautions
Childrens Ibuprofen Oral Suspension Product Label
The following document was submitted to the FDA by the labeler of this product Marc Glassman, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
Drug Facts
Otc - Active Ingredient
Active ingredient
(in each 5 mL)
Ibuprofen 100 mg
Otc - Purpose
Purpose
Pain reliever/fever reducer
Indications & Usage
Uses temporarily:
• relieves minor aches and pains due to the common cold,
flu, sore throat, headache and toothache
• reduces fever
Warnings
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
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.
Otc - Do Not Use
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
Otc - Ask Doctor
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
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if the child is
• under a doctor's care for any serious condition
• taking any other drug
Otc - When Using
When using this product
• take with food or milk if stomach upset occurs
Otc - Stop Use
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
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. ln case of overdose, get
medical help or contact a Poison Control Center right
away. (1-800-222-1222)
Dosage & Administration
Directions
• 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 (Ib) | 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
Other Safety Information
Other information
• each 5 mL contains: sodium 2 mg
• store between 20-25oC (68-77oF)
• do not use if carton is opened or printed bottle
neckband is broken or missing
• see bottom panel for lot number and expiration date
Inactive Ingredient
Inactive ingredients
Acesulfame potassium, anhydrous citric acid,
carboxymethylcellulose sodium, D&C Yellow #10, FD&C
Red #40, flavors, glycerin, microcrystalline cellulose,
polysorbate 80, propylene glycol, purified water, sodium
benzoate, sucrose, and xanthan gum
Product Label
MARC'S®
Children's
Ibuprofen
Pain Reliever/Fever Reducer
NDC 68998-320-24 compare to the active ingredient
in children's Motrin®**
MARC'S®
SEE NEW WARNINGS
Children's
Ibuprofen
Oral Suspension (NSAID)
100 mg per 5 mL
Pain Reliever/Fever Reducer
•Alcohol-Free
• Lasts up to 8 Hours
• For Ages 2 to 11 Years
Original Berry Flavor
4 FL OZ (118 mL)
Important: Read all product information before using.
Keep this box for important informatlon.
This product is intended for use in children.
**This product is not manufactured or distributed by McNeil
Consumer Healthcare, distributor of Children's Motrin®
Distributed by: Marc Glassman,lnc. BX-091
West 1301h street
Cleveland, OH 44130
Bottle Label
Carton Label
res
* Please review the disclaimer below.