CHILDRENS IBUPROFEN ORAL SUSPENSION- ibuprofen suspension

Childrens Ibuprofen Oral Suspension by

Drug Labeling and Warnings

Childrens Ibuprofen Oral Suspension by is a Otc medication manufactured, distributed, or labeled by Marc Glassman, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient

(in each 5 mL)

Ibuprofen 100 mg

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.

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

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

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

WHEN USING

When using this product
take with food or milk if stomach upset occurs

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

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

INGREDIENTS AND APPEARANCE

CHILDRENS IBUPROFEN ORAL SUSPENSION 
ibuprofen suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68998-320
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM)	IBUPROFEN	100 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
GLYCERIN (UNII: PDC6A3C0OX)
FD&C RED NO. 40 (UNII: WZB9127XOA)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SUCROSE (UNII: C151H8M554)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	orange	Score
Shape		Size
Flavor	BERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68998-320-24	1 in 1 PACKAGE	03/09/2020
1		118 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA210602	03/09/2020

Labeler - Marc Glassman, Inc. (094487477)