INFANTS RELIEF  NON-STAINING FORMULA- dimethicone 410 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
Non-Staining 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.

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, Sodium Benzoate, Sodium Citrate, Sucralose

Distributed by: CVS/pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895

PRINCIPAL DISPLAY PANEL - 15 mL Bottle Carton

CVS®
pharmacy

Compare to the
active ingredient in
Infants' MYLICON
® Drops*

Infants'
GAS
RELIEF
NON-STAINING FORMULA

SIMETHICONE/ANTIGAS

• No alcohol
• No saccharin
• No artificial
flavor

50 Doses
0.5 FL OZ (15 mL)

Principal Display Panel - 15 mL Bottle Carton
INFANTS RELIEF   NON-STAINING FORMULA
dimethicone 410 liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-102
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dimethicone 410 (UNII: TYU5GP6XGE) (Dimethicone 410 - UNII:TYU5GP6XGE) Dimethicone 41020 mg  in 0.3 mL
Inactive Ingredients
Ingredient NameStrength
Sodium Benzoate (UNII: OJ245FE5EU)  
Citric Acid Monohydrate (UNII: 2968PHW8QP)  
Hypromelloses (UNII: 3NXW29V3WO)  
Sucralose (UNII: 96K6UQ3ZD4)  
Vanillin (UNII: CHI530446X)  
Sodium Citrate (UNII: 1Q73Q2JULR)  
Water (UNII: 059QF0KO0R)  
Product Characteristics
Color    Score    
ShapeSize
FlavorVANILLA, STRAWBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59779-102-051 in 1 CARTON
115 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33202/03/2012
Labeler - CVS (062312574)
Registrant - davAgen Pharmaceutical, LLC (967545935)
Establishment
NameAddressID/FEIBusiness Operations
davAgen Pharmaceutical, LLC967545935MANUFACTURE, PACK, LABEL, ANALYSIS

Revised: 6/2012
Document Id: ed7b2cd3-a25d-444a-a9df-41b52e12b161
Set id: d91c8fa1-9036-4c80-9b15-65100a3a7be3
Version: 1
Effective Time: 20120614
 
CVS