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NDC 49035-0585-21 Ultra Strength Gas Relief 180 mg/1 Details

Ultra Strength Gas Relief 180 mg/1

Ultra Strength Gas Relief is a ORAL CAPSULE, LIQUID FILLED in the HUMAN OTC DRUG category. It is labeled and distributed by Wal-Mart Stores 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: 49035-0585-21
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Simethicone

Product Information

NDC	49035-0585
Product ID	49035-585_a1c5ded6-8796-4f12-820f-0177c281506c
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	Ultra Strength Gas Relief
Proprietary Name Suffix	n/a
Non-Proprietary Name	Simethicone
Product Type	HUMAN OTC DRUG
Dosage Form	CAPSULE, LIQUID FILLED
Route	ORAL
Active Ingredient Strength	180
Active Ingredient Units	mg/1
Substance Name	DIMETHICONE
Labeler Name	Wal-Mart Stores 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 49035-0585-21 (49035058521)

Pricing Information	N/A
NDC Package Code	49035-585-21
Billing NDC	49035058521
Package	50 CAPSULE, LIQUID FILLED in 1 BOTTLE (49035-585-21)
Marketing Start Date	2017-10-24
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 206d57ec-c854-496e-af53-7d8b2a208d85 Details

Active ingredient (in each softgel)

Simethicone 180 mg

Purpose

Antigas

Use

for the relief of

pressure and bloating commonly referred to as gas

Warnings

Keep out of reach of children

Directions

adults: swallow with water 1 or 2 softgels as needed after meals and at bedtime
do not exceed 2 softgels in 24 hours under the advice and supervision of a physician

Other information

store at controlled room temperature 15º - 30ºC (59º - 86ºF)
protect from heat and moisture
do not use if imprinted safety seal under cap is broken or missing

Inactive ingredients

FD&C yellow#6, gelatin, glycerin, purified water and white ink

Questions or comments?

Call toll free: 1-888-287-1915

PRINCIPAL DISPLAY PANEL

Ultra Strength Gas Relief

Simethicone 180 mg Anti-gas 50 Softgels

NDC 49035-585-21

*Compare to the active ingredient in Gas-X® Ultra Strength

INGREDIENTS AND APPEARANCE

ULTRA STRENGTH GAS RELIEF

simethicone capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49035-585
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	180 mg

Ingredient Name	Strength
Inactive Ingredients
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	orange (clear)	Score	no score
Shape	capsule (oval)	Size	10mm
Flavor		Imprint Code	PC3
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:49035-585-21	50 in 1 BOTTLE; Type 0: Not a Combination Product	10/24/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part332	10/24/2017

Labeler - Wal-Mart Stores Inc (051957769)

Name	Address	ID/FEI	Business Operations
Establishment
Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.		421293287	manufacture(49035-585) , analysis(49035-585)

Revised: 10/2017

Document Id: a1c5ded6-8796-4f12-820f-0177c281506c

Set id: 206d57ec-c854-496e-af53-7d8b2a208d85

Version: 1

Effective Time: 20171024