INFANTS GAS RELIEF - simethicone solution/ drops 
Supervalu Inc.

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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Equaline Infant's Gas Relief Drops

ACTIVE INGREDIENT (in each 0.3 mL)

Simethicone 20 mg

PURPOSE

Antigas

USE(S)

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 THE 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 under 2 under 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

Compare to Mylicon® infant drops active ingredient*

NDC 41163-096-09

EQUALINE


infants'

gas relief

drops


simethicone 20 mg 

(anti-gas)




DYE-FREE

NON-STAINING

**USE AS DIRECTED

1 FL OZ (30 mL)


89
INFANTS GAS RELIEF 
simethicone solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41163-096
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
BENZOIC ACID (UNII: 8SKN0B0MIM)  
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
ColorWHITE (off-white) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41163-096-091 in 1 CARTON08/26/2021
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 FINALpart33208/26/2021
Labeler - Supervalu Inc. (006961411)
Establishment
NameAddressID/FEIBusiness Operations
Guardian Drug Company119210276MANUFACTURE(41163-096)

Revised: 5/2021
Document Id: a9902ba0-f239-4e66-8d66-7cef39a5fdc3
Set id: a9902ba0-f239-4e66-8d66-7cef39a5fdc3
Version: 1
Effective Time: 20210512
 
Supervalu Inc.