QUALITY CHOICE INFANTS NON-STAINING GAS RELIEF - simethicone solution/ drops 
Chain Drug Marketing Association Inc.

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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Quality Choice Infants Non-Staining Gas Relief 

ACTIVE INGREDIENT (in each 0.3 mL)

Simethicone 20 mg

PURPOSE

Antigas

USE(S)

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 right away.

DIRECTIONS


 age (yr)weight (lb)dose
 infants under 2 under 240.3 mL
 children over 2over 240.6 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

NDC 63868-112-01

QC

Quality Choice 

*Compare to the Active Ingredient in Mylicon® 

Non-Staining Infants' Drops


Infants' Non-Staining

Gas Relief Drops

Antigas

Simethicone 20 mg


Fast Relief of Gas Symptoms 

No Artificial Flavor 

Alcohol Free

Dye Free

Gentle & Safe**

**Use only as directed;

do not exceed 12 doses per day.

1 FL OZ (30mL)


QC-520-30mL


QUALITY CHOICE INFANTS NON-STAINING GAS RELIEF 
simethicone solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-112
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)  
SORBITOL (UNII: 506T60A25R)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
ColorWHITE (off-white) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63868-112-011 in 1 CARTON07/29/2022
130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33207/29/2022
Labeler - Chain Drug Marketing Association Inc. (011920774)

Revised: 7/2022
Document Id: f956aff6-1d65-4639-81c7-3116c37b777a
Set id: f956aff6-1d65-4639-81c7-3116c37b777a
Version: 1
Effective Time: 20220729
 
Chain Drug Marketing Association Inc.