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NDC 62011-0187-01 infants gas relief drops 20 mg/.3mL Details

infants gas relief drops 20 mg/.3mL

infants gas relief drops is a ORAL EMULSION in the HUMAN OTC DRUG category. It is labeled and distributed by Strategic Sourcing Services LLC. 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: 62011-0187-01
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Simethicone

Product Information

NDC	62011-0187
Product ID	62011-0187_f17b1bb2-3b3b-471c-9496-c4853c2b5257
Associated GPIs	52200020001810
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 drops
Proprietary Name Suffix	n/a
Non-Proprietary Name	simethicone
Product Type	HUMAN OTC DRUG
Dosage Form	EMULSION
Route	ORAL
Active Ingredient Strength	20
Active Ingredient Units	mg/.3mL
Substance Name	DIMETHICONE
Labeler Name	Strategic Sourcing Services 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 62011-0187-01 (62011018701)

Pricing Information
NDC Package Code	62011-0187-1
Billing NDC	62011018701
Package	1 BOTTLE, DROPPER in 1 CARTON (62011-0187-1) / 30 mL in 1 BOTTLE, DROPPER
Marketing Start Date	2019-10-21
NDC Exclude Flag	N
Price Per Unit	0.09709
Pricing Unit	ML
Effective Date	2022-11-23
NDC Description	HM INF GAS RELIEF 20 MG/0.3 ML
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	1, 5
Classification for Rate Setting	G
As of Date	2022-11-23

This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis

Standard Product Labeling (SPL)/Prescribing Information SPL fc6887a8-994e-4b2b-ab67-622d1c1f03dd Details

Active ingredient (in each 0.3 mL)

simethicone 20 mg

Purpose

Antigas

Uses

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 recommend 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 under2	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 62011-0187-1

Compare to Mylicon® Non-Staining Infants' Drops Active Ingredient*

DYE FREE FORMULA

Infants' Gas Relief Drops

Simethicone 20 mg

Anti-gas

Soothing Relief For Pressure, Bloating & Gas Symptoms

1 fl oz (30 mL)

INGREDIENTS AND APPEARANCE

INFANTS GAS RELIEF DROPS

simethicone emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:62011-0187
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
SORBITOL (UNII: 506T60A25R)
XANTHAN GUM (UNII: TTV12P4NEE)
BENZOIC ACID (UNII: 8SKN0B0MIM)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:62011-0187-1	1 in 1 CARTON	10/21/2019
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	10/21/2019

Labeler - Strategic Sourcing Services LLC (116956644)

Revised: 1/2022

Document Id: f17b1bb2-3b3b-471c-9496-c4853c2b5257

Set id: fc6887a8-994e-4b2b-ab67-622d1c1f03dd

Version: 5

Effective Time: 20220111