INFANTS GAS RELIEF NON-STAINING FORMULA- dimethicone liquid

Infants Gas Relief by

Drug Labeling and Warnings

Infants Gas Relief by is a Otc medication manufactured, distributed, or labeled by CVS, davAgen Pharmaceutical, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

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 doses 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 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 (yr)	Weight (lb)	Dose
infants under 2	under 24	0.3 mL
children over 2	over 24	0.6 mL

Other information

• do not use if printed foil seal under cap is torn or missing
• store at room temperature
• do not freeze
• see bottom panel for lot number and expiration date

Inactive ingredients

Carbomer 934-P, Citric Acid, Hydroxypropyl Methylcellulose, Natural Flavors, Purified Water, Sodium Benzoate, Sodium Citrate, Sucralose

SPL UNCLASSIFIED SECTION

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton

CVS
pharmacy®

Compare to the
active ingredient in
Infants' MYLICON® Drops*

Infants'
GAS
RELIEF
NON-STAINING FORMULA

SIMETHICONE/ANTIGAS

• No alcohol
• No saccharin
• No artificial flavor

100 Doses
1 FL OZ (30 mL)

INGREDIENTS AND APPEARANCE

INFANTS GAS RELIEF   NON-STAINING FORMULA
dimethicone liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59779-704
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	20 mg  in 0.3 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM BENZOATE (UNII: OJ245FE5EU)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
HYPROMELLOSES (UNII: 3NXW29V3WO)
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) (UNII: Z135WT9208)
SUCRALOSE (UNII: 96K6UQ3ZD4)
VANILLIN (UNII: CHI530446X)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color		Score
Shape		Size
Flavor	VANILLA, STRAWBERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59779-704-01	1 in 1 CARTON
1		30 mL in 1 BOTTLE, DROPPER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part332	02/03/2013

Labeler - CVS (062312574)

Registrant - davAgen Pharmaceutical, LLC (967545935)

Establishment
Name	Address	ID/FEI	Business Operations
davAgen Pharmaceutical, LLC		967545935	MANUFACTURE(59779-704) , PACK(59779-704) , LABEL(59779-704) , ANALYSIS(59779-704)