Quality Choice Infants Dye Free Gas Relief Drops

Manufacturer
CHAIN DRUG MARKETING ASSOCIATION
Effective date
2025-12-04
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:19:52

Label at a glance#

ProductQuality Choice Infants Dye Free Gas Relief
Active ingredientDIMETHICONE, UNSPECIFIED
Label structure8 sections

Indications and uses

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

Dosage and administration

shake well before using find right dose on chart below. If possible, use weight to dose; otherwise, use age. only use the enclosed syringe. Do not use other syringe, dropper, spoon or dosing device when giving this medicine to your child. remove cap and insert syringe into the bottle pull syringe up until filled to the prescribed level. If you pass the prescribed level, simply push syringe back until you have reac...

Storage and handling

tamper evident: do not use if printed seal under cap is broken or missing store at room temperature do not freeze see bottom panel for lot number and expiration date

Label contents#

Full prescribing information#

Active ingredient (in each 0.3 mL)

OTC - ACTIVE INGREDIENT SECTION

Simethicone 20 mg

Purpose

OTC - PURPOSE SECTION

Antigas

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Keep out of reach of children. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222. Quick medical attention is critical even if you do not notice any signs or symptoms.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

  • shake well before using
  • find right dose on chart below. If possible, use weight to dose; otherwise, use age.
  • only use the enclosed syringe. Do not use other syringe, dropper, spoon or dosing device when giving this medicine to your child.
  • remove cap and insert syringe into the bottle
  • pull syringe up until filled to the prescribed level. If you pass the prescribed level, simply push syringe back until you have reached the desired level. Slowly dispense the liquid into your child’s mouth (toward inner cheek).
  • all dosages may be repeated as needed, after meals and at bedtime or as directed by a physician.
  • do not exceed 12 doses per day.
  • dosage can also be mixed with 1 oz. cool water, infant formula or other suitable liquids
  • replace cap tightly to maintain child resistance
  • mL = milliliter

Age (yr)

Weight (lb)

Dose (mL)

infants under 2

under 24

0.3

children over 2

over 24

0.6

Other information

STORAGE AND HANDLING SECTION

  • tamper evident: do not use if printed seal under cap is broken or missing
  • store at room temperature
  • do not freeze
  • see bottom panel for lot number and expiration date

Inactive ingredients

INACTIVE INGREDIENT SECTION

carboxymethylcellulose sodium, citric acid, flavors, microcrystalline cellulose, polysorbate 60, potassium sorbate, purified water, sodium benzoate, sorbitan monostearate, sorbitol, xanthan gum

Questions or comments ?

OTC - QUESTIONS SECTION

Call 1-866-467-2748

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC# 63868-696-30

QUALITY CHOICE ®

*Compare to the Active Ingredient in Infants’ Mylicon ®

Infants’ Dye-Free Gas Relief Drops

Relieves Gas Symptoms

Simethicone Antigas 20 mg

No Saccharin

No Artificial Colors

No Artificial Flavor

Non-Staining

1 Fl. OZ (30ml)

100 Doses

100% QC SATISFACTION GUARANTEED

Distributed by: C.D.M.A. Inc. ©

43157 W 9 Mile Rd

Novi, MI 48375

www.qualitychoice.com

Questions: 248-449-9300

*This product is not manufactured or distributed by Infirst Healthcare Inc., the distributor of Infants’ MYLICON ®Drops.

Quality Choice Infants Dye Free Gas Relief Simethicone 20 mg
Quality Choice Infants Dye Free Gas Relief Simethicone 20 mg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198857simethicone 20 MG in 0.3 mL Oral SuspensionPSN6
198857simethicone 66.7 MG/ML Oral SuspensionSCD6
198857simethicone 20 MG per 0.3 ML Oral SuspensionSY6
198857simethicone 40 MG per 0.6 ML Oral SuspensionSY6

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130635515981409GTIN-13: 0635515981409
EAN-13: 0635515981409
GTIN-12: 635515981409
UPC-A: 635515981409
GTIN storage (14 digits): 00635515981409
766DF30MYLFC.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-696-30Quality Choice Infants Dye Free Gas Relief30 mL in 1 BOTTLE, DROPPEREMULSION306
63868-696-30Quality Choice Infants Dye Free Gas Relief1 in 1 CARTONEMULSION16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-696-30ML - Milliliter63868-696535a7422-10b9-4db9-be53-508ddc6eed3b12022-11-07

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63868-69663868-696-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

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 Dye Free Gas ReliefSIMETHICONECHAIN DRUG MARKETING ASSOCIATION6b8a1eaa-6f8c-4ab6-81e0-9d64f6f1b5e42025-12-04WarningsExact identifier
ndc (package): 63868-696-30
ndc (product): 63868-696
ndc11 (package): 63868069630
spl id: 451d7550-2e7d-051e-e063-6394a90aea9e
spl set id: 6b8a1eaa-6f8c-4ab6-81e0-9d64f6f1b5e4

Reported adverse events (FAERS/openFDA)#

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