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NDC 41163-0096-09 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 Supervalu Inc.. The primary component is DIMETHICONE.

Product Information

NDC	41163-0096
Product ID	41163-096_a9902ba0-f239-4e66-8d66-7cef39a5fdc3
Associated GPIs
GCN Sequence Number	002815
GCN Sequence Number Description	simethicone DROPS SUSP 40MG/0.6ML ORAL
HIC3	D4N
HIC3 Description	ANTIFLATULENTS
GCN	08260
HICL Sequence Number	001224
HICL Sequence Number Description	SIMETHICONE
Brand/Generic	Generic
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	Supervalu 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 41163-0096-09 (41163009609)

Pricing Information	N/A
NDC Package Code	41163-096-09
Billing NDC	41163009609
Package	1 BOTTLE, DROPPER in 1 CARTON (41163-096-09) / 30 mL in 1 BOTTLE, DROPPER
Marketing Start Date	2021-08-26
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL a9902ba0-f239-4e66-8d66-7cef39a5fdc3 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 THE 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

Compare to Mylicon® infant drops active ingredient*

NDC 41163-096-09

EQUALINE

infants'

gas relief

drops

simethicone 20 mg

(anti-gas)

gently breaks down baby's gas bubbles
safe enough to use at every feeding**

DYE-FREE

NON-STAINING

**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:41163-096
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:41163-096-09	1 in 1 CARTON	08/26/2021
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	08/26/2021

Labeler - Supervalu Inc. (006961411)

Name	Address	ID/FEI	Business Operations
Establishment
Guardian Drug Company		119210276	MANUFACTURE(41163-096)

Revised: 5/2021

Document Id: a9902ba0-f239-4e66-8d66-7cef39a5fdc3

Set id: a9902ba0-f239-4e66-8d66-7cef39a5fdc3

Version: 1

Effective Time: 20210512