INFANTS GAS RELIEF  NON-STAINING FORMULA- dimethicone liquid 
Walgreens

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.

(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, Sodium Benzoate, Sodium Citrate, Sucralose

Questions or comments?

1-800-Walgreens (1-800-925-4733)

DISTRIBUTED BY:
WALGREEN CO.
200 WILMOT ROAD
DEERFIELD, IL 60015

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton

Well at
Walgreens

WALGREENS PHARMACIST RECOMMENDED

Infants'

Gas Relief

Simethicone 20 mg/Dose
Anti-Gas

100 DOSES

Compare to Infants' Mylicon®
Drops active ingredient‡‡

1 FL OZ (30 mL)

Principal Display Panel - 30 mL Bottle Carton
INFANTS GAS RELIEF   NON-STAINING FORMULA
dimethicone liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-5345
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)  
Product Characteristics
Color    Score    
ShapeSize
FlavorVANILLA, STRAWBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0363-5345-011 in 1 CARTON
130 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33204/15/2013
Labeler - Walgreens (008965063)
Registrant - davAgen Pharmaceutical, LLC (967545935)
Establishment
NameAddressID/FEIBusiness Operations
davAgen Pharmaceutical, LLC967545935MANUFACTURE(0363-5345) , PACK(0363-5345) , LABEL(0363-5345) , ANALYSIS(0363-5345)

Revised: 12/2013
Document Id: 5a8606c8-c137-40a8-b3d8-87a70c44f2fa
Set id: 7b44851a-9fe4-4e5d-922b-89fe84d301ca
Version: 1
Effective Time: 20131203
 
Walgreens