Search by Drug Name or NDC

NDC 63868-0112-01 Quality Choice Infants Non-staining Gas relief 20 mg/.3mL Details

Quality Choice Infants Non-staining Gas relief 20 mg/.3mL

Quality Choice Infants Non-staining Gas relief is a ORAL SOLUTION/ DROPS in the HUMAN OTC DRUG category. It is labeled and distributed by Chain Drug Marketing Association Inc.. The primary component is DIMETHICONE.

MedlinePlus Drug Summary

Simethicone is used to treat the symptoms of gas such as uncomfortable or painful pressure, fullness, and bloating. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

Related Packages: 63868-0112-01
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Simethicone

Product Information

NDC	63868-0112
Product ID	63868-112_f956aff6-1d65-4639-81c7-3116c37b777a
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Quality Choice Infants Non-staining Gas relief
Proprietary Name Suffix	n/a
Non-Proprietary Name	Simethicone
Product Type	HUMAN OTC DRUG
Dosage Form	SOLUTION/ DROPS
Route	ORAL
Active Ingredient Strength	20
Active Ingredient Units	mg/.3mL
Substance Name	DIMETHICONE
Labeler Name	Chain Drug Marketing Association Inc.
Pharmaceutical Class	Skin Barrier Activity [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part332
Listing Certified Through	2024-12-31

Package

Package Images

NDC 63868-0112-01 (63868011201)

Pricing Information	N/A
NDC Package Code	63868-112-01
Billing NDC	63868011201
Package	1 BOTTLE, DROPPER in 1 CARTON (63868-112-01) / 30 mL in 1 BOTTLE, DROPPER
Marketing Start Date	2022-07-29
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL f956aff6-1d65-4639-81c7-3116c37b777a Details

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

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 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

NDC 63868-112-01

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)

INGREDIENTS AND APPEARANCE

QUALITY CHOICE INFANTS NON-STAINING GAS RELIEF

simethicone solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63868-112
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	20 mg in 0.3 mL

Ingredient Name	Strength
Inactive Ingredients
BENZOIC ACID (UNII: 8SKN0B0MIM)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	WHITE (off-white)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:63868-112-01	1 in 1 CARTON	07/29/2022
1		30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part332	07/29/2022

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