INFANTS GAS RELIEF DROPS- simethicone emulsion 
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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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Select Brand Infant's Gas Relief Drops

Active ingredient (in each 0.3 mL)

simethicone 20 mg

Purpose

Antigas

Uses

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 immediately.

Directions


age (yr)
weight (lb)
dose
infants under2
under 24
0.3 mL
children over 2
over 24
0.6 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

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Compare to the active ingredient in Infants Mylicon® Drops

Infant's Gas Relief Drops

Simethicone

Anti-Gas

Non-staining

Excess Gas relief

Alcohol Free

Saccharin Free

No Artificial Flaovr


1 fl oz (30 mL)

BOX

INFANTS GAS RELIEF DROPS 
simethicone emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:15127-042
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
SORBITOL (UNII: 506T60A25R)  
XANTHAN GUM (UNII: TTV12P4NEE)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:15127-042-171 in 1 CARTON
130 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33202/02/2013
Labeler - Select Brand (043562370)

Revised: 9/2014
Document Id: 0f3c6d9c-2054-42b3-820b-dd2d32e6fe3c
Set id: 96612f9b-aa15-4ef5-9ec4-eab44f3c69c7
Version: 1
Effective Time: 20140905
 
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