FDA.reportPublic FDA data

Quality Choice Infants Non-staining Gas relief

Manufacturer
Chain Drug Marketing Association Inc.
Effective date
2024-08-23
Label type
Human OTC Drug Label
Version
2
Source
full-release
Hydrated at
2026-06-01 00:17:40

Label at a glance#

ProductQuality Choice Infants Non-staining Gas relief
Active ingredientDIMETHICONE
Label structure9 sections

Dosage and administration

shake well before using all dosages may be repeated as needed, after meals and at bedtime  fill enclosed dropper to recommended dosage level dispense liquid slowly into baby's mouth, toward the inner cheek may mix with 1 oz. of cool water, infant formula or other suitable liquids clean dropper after each use and close the bottle to maintain child resistance  age (yr) weight (lb) dose  infants under 2  under 24 0.3...

Storage and handling

store at room temperature

Label contents#

Full prescribing information#

ACTIVE INGREDIENT (in each 0.3 mL)

OTC - ACTIVE INGREDIENT SECTION

Simethicone 20 mg

PURPOSE

OTC - PURPOSE SECTION

Antigas

USE(S)

INDICATIONS & USAGE SECTION

relieves the symptoms of gas frequently caused by air swallowing or certain formulas or foods


WARNINGS

WARNINGS SECTION

When using this product do not exceed 12 doses per day

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • shake well before using
  • all dosages may be repeated as needed, after meals and at bedtime 
  • fill enclosed dropper to recommended dosage level
  • dispense liquid slowly into baby's mouth, toward the inner cheek
  • may mix with 1 oz. of cool water, infant formula or other suitable liquids
  • clean dropper after each use and close the bottle to maintain child resistance

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

OTHER INFORMATION

STORAGE AND HANDLING SECTION

store at room temperature

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

benzoic acid, flavor, magnesium aluminum silicate, purified water, simethicone emulsion, sorbitol, xanthan gum

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

83324-133-01

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)

520-qch-label.jpg520-qch-label.jpg520-qch-carton.jpg520-qch-carton.jpg

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIMETHICONE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83324-133-01Quality Choice Infants Non-staining Gas relief30 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS302
83324-133-01Quality Choice Infants Non-staining Gas relief1 in 1 CARTONSOLUTION/ DROPS12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83324-133QUALITY CHOICE INFANTS NON-STAINING GAS RELIEF (SIMETHICONE) SOLUTION/ DROPS [CHAIN DRUG MARKETING ASSOCIATION INC.]2Current NDC, 2 package rows20240824_17e181e5-6527-54d0-e063-6294a90addc2.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83324-133-01ML - Milliliter83324-13350d8f59d-d821-455f-aa82-ebb4765ad9c212025-08-11

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83324-13383324-133-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIMETHICONE92RU3N3Y1OACTIB
BENZOIC ACID8SKN0B0MIMIACT
MAGNESIUM ALUMINUM SILICATE6M3P64V0NCIACT
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
XANTHAN GUMTTV12P4NEEIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Quality Choice Infants Non-staining Gas reliefSIMETHICONEChain Drug Marketing Association Inc.17e181e5-6527-54d0-e063-6294a90addc22024-08-23WarningsExact identifier
ndc (package): 83324-133-01
ndc (product): 83324-133
ndc11 (package): 83324013301
spl id: 90e2b49f-a358-4228-9b0c-130ebafd5640
spl set id: 17e181e5-6527-54d0-e063-6294a90addc2

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.