INFANTS SIMETHICONE- simethicone solution/ drops
Qualitest Pharmaceuticals

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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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

This is an image of the carton for Infant's Simethicone Drops.

INFANTS SIMETHICONE
simethicone solution/ drops

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	63.3 mg in 1 mL
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4)	SILICON DIOXIDE	3.7 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
CARBOMER 934 (UNII: Z135WT9208)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
FD&C RED NO. 3 (UNII: PN2ZH5LOQY)
HYPROMELLOSES (UNII: 3NXW29V3WO)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE (UNII: 1Q73Q2JULR)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0603-0894-50	1 in 1 CARTON	10/16/1997	12/31/2014
1		30 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part332	10/16/1997	12/31/2014

Labeler - Qualitest Pharmaceuticals (011103059)

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

Revised: 7/2015

Document Id: dc41664c-560a-4463-9df7-8bbfc4ebcb17

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

Version: 5

Effective Time: 20150701

Qualitest Pharmaceuticals