GAS RELIEF DROPS INFANTS - simethicone emulsion 
Strategic Sourcing Services LLC

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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gas relief drops infant's

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

age (yr)weight (lb)dose
infants under2under 240.3 mL
children over 2over 240.6 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

sunmark

COMPARE TO MYLICON NON-STAINING INFANTS' DROPS ACTIVE INGREDIENT

NDC 49348-740-27

gas relief drops infant's

Fast relief of gas symptoms

Alcohol and saccharin Free

NON-STAINING FORMULA

1 fl oz (30 mL) 100 DOSES

image description

GAS RELIEF DROPS INFANTS  
simethicone emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49348-740
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE20 mg  in 0.3 mL
Inactive Ingredients
Ingredient NameStrength
SORBITOL (UNII: 506T60A25R)  
XANTHAN GUM (UNII: TTV12P4NEE)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49348-740-271 in 1 CARTON09/26/2019
130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33209/26/2019
Labeler - Strategic Sourcing Services LLC (116956644)

Revised: 1/2022
Document Id: fe94ed44-7e66-46fb-856d-c37281f0ffba
Set id: a61f486b-0563-4cdf-9a56-e118e769e859
Version: 4
Effective Time: 20220107
 
Strategic Sourcing Services LLC