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NDC 36800-0119-09 Infants Gas relief 20 mg/.3mL Details

Infants Gas relief 20 mg/.3mL

Infants Gas relief is a ORAL SOLUTION/ DROPS in the HUMAN OTC DRUG category. It is labeled and distributed by Topco Associates, LLC. The primary component is DIMETHICONE.

Product Information

NDC	36800-0119
Product ID	36800-119_fd6a2537-8db2-492d-b045-6404df2fb9c3
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	Infants 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	Topco Associates, LLC
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 36800-0119-09 (36800011909)

Pricing Information	N/A
NDC Package Code	36800-119-09
Billing NDC	36800011909
Package	1 BOTTLE, DROPPER in 1 CARTON (36800-119-09) / 30 mL in 1 BOTTLE, DROPPER
Marketing Start Date	2013-03-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL fd6a2537-8db2-492d-b045-6404df2fb9c3 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 SECTION

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

PRINCIPAL DISPLAY PANEL

Topcare health

COMPARE TO MYLICON® NON-STAINING INFANTS' DROPS ACTIVE INGREDIENT*

NDC 36800-119-09

NON-STAINING

DYE-FREE

infants'

Gas Relief

Drops

SIMETHICONE 20 mg

ANTI-GAS

Gently Breaks Down Baby's Gas Bubbles
Safe Enough to Use at Every Feeding**

**use as directed

1 FL OZ (30 mL)

INGREDIENTS AND APPEARANCE

INFANTS GAS RELIEF

simethicone solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:36800-119
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:36800-119-09	1 in 1 CARTON	03/01/2013
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	03/01/2013

Labeler - Topco Associates, LLC (006935977)

Name	Address	ID/FEI	Business Operations
Establishment
Guardian Drug Company		119210276	MANUFACTURE(36800-119)

Revised: 5/2021

Document Id: fd6a2537-8db2-492d-b045-6404df2fb9c3

Set id: fd6a2537-8db2-492d-b045-6404df2fb9c3

Version: 1

Effective Time: 20210512