INFANTS GAS RELIEF - simethicone solution/ drops 
Meijer, 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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Meijer Infants 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 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 INGREDIENT SECTION

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

PRINCIPAL DISPLAY PANEL

Meijer

NDC 79481-0011-9

Compare to Mylicon® Non-Staining Infants' Drops active ingredient*


INFANTS'

gas relief

Simethicone 20 mg 


For fast relief of gas symptoms 

Gentle and safe**

No artificial flavor

Alcohol free / Dye free


Non-Staining Formula 


**Use only as directed; do not exceed 12 doses per day.

1 FL OZ (30 mL)


132
INFANTS GAS RELIEF 
simethicone solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79481-0011
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:79481-0011-91 in 1 CARTON01/18/2022
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 FINALpart33201/18/2022
Labeler - Meijer, Inc. (006959555)
Establishment
NameAddressID/FEIBusiness Operations
Guardian Drug Company119210276MANUFACTURE(79481-0011)

Revised: 1/2022
Document Id: fe4b7176-fda5-4eed-ad9e-fa0e154e9cca
Set id: e3e28a2e-8e95-4513-be78-5e930e63412f
Version: 3
Effective Time: 20220119
 
Meijer, Inc.