SUNMARK INFANTS GAS RELIEF DROPS - simethicone  emulsion 
McKesson

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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Sunmark gas relief drops infants

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 the reach of children.


Directions

Other information

store at room temperature (59oF-86oF)

Inactive ingredients

benzoic acid, red # 22, red # 28, flavor, magnesium aluminum silicate, purified water, sorbitol, xanthan gum.


Principal Display Panel

Sunmark

compare to Mylicon® Infant drops active ingredient

gas relief drops infants'

Fast relief of gas symptoms

Alcohol and Saccharin free

No artificial flavor

1 fl oz (30 mL) 100 Dosesinfants gas relief drug factsinfants gas relief

SUNMARK INFANTS GAS RELIEF DROPS 
simethicone emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49348-577
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)  
D&C RED NO. 22 (UNII: 1678RKX8RT)  
D&C RED NO. 28 (UNII: 767IP0Y5NH)  
SORBITOL (UNII: 506T60A25R)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
ColorpinkScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49348-577-341 in 1 CARTON
130 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33210/31/2003
Labeler - McKesson (177667227)

Revised: 9/2012
Document Id: 44bfb19c-57f6-46cc-b9b9-9b007dab6722
Set id: 8c2d86d8-2e67-41c2-a4ce-5a3904408a02
Version: 1
Effective Time: 20120910
 
McKesson