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NDC 69618-0045-18 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 RELIABLE 1 LABORATORIES 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: 69618-0045-18
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Simethicone

Product Information

NDC	69618-0045
Product ID	69618-045_78fed69f-82c1-48d2-a323-0c0144246e20
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	RELIABLE 1 LABORATORIES 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 69618-0045-18 (69618004518)

Pricing Information	N/A
NDC Package Code	69618-045-18
Billing NDC	69618004518
Package	180 CAPSULE, LIQUID FILLED in 1 BOTTLE (69618-045-18)
Marketing Start Date	2017-07-13
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 4a24f162-420c-4b55-aad1-01b49b69059c Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each softgel)

Simethicone 180 mg

Purpose

Anti-gas

Uses

relieves bloating, pressure or fullness commonly referred to as gas

Warnings

Stop use and ask a doctor if condition persists

Keep out of reach of children.

Directions

swallow 1 or 2 softgels as needed after a meal
do not exceed two softgels per day except under the advice and supervision of a physician

Other information

store at room temperature 59º - 86ºF (15º - 30ºC)

Inactive ingredients

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

Questions or comments?

Call: 516-341-0666

PRINCIPAL DISPLAY PANEL

Ultra Strength Gas Relief

Simethicone 180 mg Anti-gas 180 Softgels

NDC 69618-045-18

*Compare to the active ingredient in PHAZYME® Ultra Strength

INGREDIENTS AND APPEARANCE

ULTRA STRENGTH GAS RELIEF

simethicone capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69618-045
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:69618-045-18	180 in 1 BOTTLE; Type 0: Not a Combination Product	07/13/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part332	07/13/2017

Labeler - RELIABLE 1 LABORATORIES LLC (079718111)

Name	Address	ID/FEI	Business Operations
Establishment
Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.		421293287	manufacture(69618-045) , analysis(69618-045)

Revised: 7/2017

Document Id: 78fed69f-82c1-48d2-a323-0c0144246e20

Set id: 4a24f162-420c-4b55-aad1-01b49b69059c

Version: 1

Effective Time: 20170713