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NDC 69626-5200-09 Gas-Aid Drops for infants 20 mg/.3mL Details

Gas-Aid Drops for infants 20 mg/.3mL

Gas-Aid Drops for infants is a ORAL EMULSION in the HUMAN OTC DRUG category. It is labeled and distributed by Leosons. 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: 69626-5200-09
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Simethicone

Product Information

NDC	69626-5200
Product ID	69626-5200_29b85677-458a-4cf5-a64d-32db05506977
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	Gas-Aid Drops for infants
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	Leosons
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 69626-5200-09 (69626520009)

Pricing Information	N/A
NDC Package Code	69626-5200-9
Billing NDC	69626520009
Package	1 BOTTLE, DROPPER in 1 CARTON (69626-5200-9) / 30 mL in 1 BOTTLE, DROPPER
Marketing Start Date	2015-08-08
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 06665701-5f1c-4f8f-8775-e0a4a9ef2029 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

SPL UNCLASSIFIED SECTION

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 immediately.

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

Gas-Aid drops for infant's

Fast relief of

Simethicone Anti-Gas

No Saccharin or artificial flavor

Alcohol and dye Free

Non-staining

1 fl oz (30 mL)

INGREDIENTS AND APPEARANCE

GAS-AID DROPS FOR INFANTS

simethicone emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69626-5200
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:69626-5200-9	1 in 1 CARTON	08/08/2015
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	08/08/2015

Labeler - Leosons (148605470)

Registrant - Guardian Drug Company (119210276)

Name	Address	ID/FEI	Business Operations
Establishment
Guardian Drug Company		119210276	manufacture(69626-5200)

Revised: 1/2022

Document Id: 29b85677-458a-4cf5-a64d-32db05506977

Set id: 06665701-5f1c-4f8f-8775-e0a4a9ef2029

Version: 7

Effective Time: 20220113