INFANTS GAS RELIEF  ORIGINAL FORMULA- dimethicone liquid 
CVS

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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Infant's Gas Relief
Original Formula

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

Age (yr)Weight (lb)Dose
infants under 2under 240.3 mL
children over 2over 240.6 mL

Other information

Inactive ingredients

Carbomer 934-P, Citric Acid, Hydroxypropyl Methylcellulose, Natural Flavors, Purified Water, Red #3, Sodium Benzoate, Sodium Citrate, Sucralose

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
ORIGINAL FORMULA

SIMETHICONE/ANTIGAS

100 Doses
1 FL OZ (30 mL)

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton
INFANTS GAS RELIEF   ORIGINAL FORMULA
dimethicone liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-701
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
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)  
FD&C Red No. 3 (UNII: PN2ZH5LOQY)  
Product Characteristics
ColorPINK (Opaque) Score    
ShapeSize
FlavorVANILLA, STRAWBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59779-701-0136 in 1 BOX
11 in 1 CARTON
130 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33201/05/2013
Labeler - CVS (062312574)
Registrant - davAgen Pharmaceutical, LLC (967545935)
Establishment
NameAddressID/FEIBusiness Operations
davAgen Pharmaceutical, LLC967545935MANUFACTURE(59779-701) , PACK(59779-701) , LABEL(59779-701) , ANALYSIS(59779-701)

Revised: 3/2013
Document Id: 515304f7-b849-4c1a-8384-ad48f9199777
Set id: 010e5c7e-1c2c-49ab-a9ca-6e89ae86a6d3
Version: 1
Effective Time: 20130328
 
CVS