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Infants Simethicone

Dosage form: solution/ drops
Ingredients: SIMETHICONE 63.3mg in 1mL, SILICON DIOXIDE 3.7mg in 1mL
Labeler: Qualitest Pharmaceuticals
NDC code: 0603-0894

Infants Simethicone Drops

Active ingredient (in each 0.3 mL)

Simethicone 20 mg

Purpose

Anti-gas

Uses

Relieves the discomfort of infant gas frequently caused by air swallowing or certain formulas or foods.

Warnings

Keep out of reach of children.

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

Directions

shake well before using
all dosages may be repeated as needed, after meals and at bedtime or as directed by a physician. Do not exceed 12 doses per day.
fill enclosed dropper to recommended dosage level and dispense liquid slowly into baby’s mouth, toward the inner cheek
dosage can also be mixed with 1 oz of cool water, infant formula or other suitable liquids
for best results, clean dropper after each use and replace original cap

Age	Weight	Dose
infants under 2 years	under 24 lbs	0.3 mL
children over 2 years	over 24 lbs	0.6 mL

Other information

store at room temperature 15°- 30°C (59°- 86°F)
do not freeze

You may report serious side effects to: 130 Vintage Drive, Huntsville, AL 35811.

Inactive ingredients

carbomer, citric acid, FD&C red #3, flavor, hypromellose, purified water, saccharin sodium, sodium benzoate, sodium citrate

Made in the USA
for Qualitest Pharmaceuticals
Huntsville, AL 35811

Rev. 3/15 R8
8276455 0894

PRINCIPAL DISPLAY PANEL

INFANTS SIMETHICONE
simethicone solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0603-0894
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SIMETHICONE (SIMETHICONE)	SIMETHICONE	63.3 mg in 1 mL
SILICON DIOXIDE (SILICON DIOXIDE)	SILICON DIOXIDE	3.7 mg in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)
ANHYDROUS CITRIC ACID
FD&C RED NO. 3
HYPROMELLOSES
WATER
SACCHARIN SODIUM
SODIUM BENZOATE
SODIUM CITRATE

Packaging
#	Item Code	Package Description
1	NDC:0603-0894-50	1 BOTTLE in 1 CARTON
1		30 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part332	10/16/1997

Labeler - Qualitest Pharmaceuticals (011103059)

Establishment
Name	Address	ID/FEI	Operations
Vintage Pharmaceuticals-Huntsville		825839835	ANALYSIS(0603-0894), LABEL(0603-0894), MANUFACTURE(0603-0894), PACK(0603-0894)

Revised: 07/2015

Document Id: 00e31dd0-462a-480c-b558-3a8c8f503734

Set id: ae36c885-22f2-48a6-849a-d2d89a6d24a3

Version: 4

Effective Time: 20150701

Qualitest Pharmaceuticals

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer