INFANTS GAS RELIEF DROPS- simethicone emulsion

infants gas relief drops by

Drug Labeling and Warnings

infants gas relief drops by is a Otc medication manufactured, distributed, or labeled by Strategic Sourcing Services LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each 0.3 mL)

simethicone 20 mg

Purpose

Antigas

Uses

relieves the symptoms of gas frequently caused by air swallowing or certain formulas or foods

Warnings

When using this product

do not exceed 12 doses per day

Keep out of reach of children. In case of overdose get medical help or contact a poison control center right away.

Directions

• shake well before using
• all dosages may be repeated as needed, after meals and at bedtime
• fill enclosed dropper to recommend dosage level
• dispense liquid slowly into baby's mouth, toward the inner cheek
• may mix with 1 oz. of cool water, infant formula or other suitable liquids
• clean dropper after each use and close the bottle to maintain child resistance

age (yr)	weight (lb)	dose
infants under2	under 24	0.3 mL
children over 2	over 24	0.6 mL

Other information

store at room temperature

Inactive ingredients

benzoic acid, flavor, magnesium aluminum silicate, purified water, simethicone emulsion, sorbitol, xanthan gum

Principal Display Panel

NDC: 62011-0187-1

Compare to Mylicon® Non-Staining Infants' Drops Active Ingredient*

DYE FREE FORMULA

Infants' Gas Relief Drops

Simethicone 20 mg

Anti-gas

Soothing Relief For Pressure, Bloating & Gas Symptoms

1 fl oz (30 mL)

INGREDIENTS AND APPEARANCE

INFANTS GAS RELIEF DROPS  
simethicone emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62011-0187
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
SORBITOL (UNII: 506T60A25R)
XANTHAN GUM (UNII: TTV12P4NEE)
BENZOIC ACID (UNII: 8SKN0B0MIM)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62011-0187-1	1 in 1 CARTON	10/21/2019
1		30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part332	10/21/2019

Labeler - Strategic Sourcing Services LLC (116956644)