ULTRASTRENGTH GAS RELIEF- simethicone soft gelatin capsules capsule

Ultrastrength Gas Relief by

Drug Labeling and Warnings

Ultrastrength Gas Relief by is a Otc medication manufactured, distributed, or labeled by CVS PHARMACY, INC, TIME CAP LABORATORIES, INC., MARKSANS PHARMA LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

ACTIVE INGREDIENT

Active ingredient (in each softgel)

Simethicone 180 mg

PURPOSE

Purpose

Anti-gas

INDICATIONS & USAGE

Use for the relief of

• pressure and bloating commonly referred to as gas.

WARNINGS

​Warning

Keep out of reach of children.

DOSAGE & ADMINISTRATION

Directions

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

OTHER SAFETY INFORMATION

Other information

• store at room temperature
• protect from light, heat and moisture

INACTIVE INGREDIENT

Inactive ingredients

FD&C yellow no. 6, gelatin, glycerol, medium chain triglyceride, peppermint oil, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide

QUESTIONS

Questions or comments? Call 1-877-290-4008

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ULTRASTRENGTH GAS RELIEF 
simethicone soft gelatin capsules capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51316-621
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
SHELLAC (UNII: 46N107B71O)
GLYCERIN (UNII: PDC6A3C0OX)
PEPPERMINT OIL (UNII: AV092KU4JH)
SORBITAN (UNII: 6O92ICV9RU)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
GELATIN (UNII: 2G86QN327L)

Product Characteristics
Color	orange (Orange opaque)	Score	no score
Shape	OVAL	Size	11mm
Flavor		Imprint Code	107
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51316-621-76	5 in 1 CARTON	02/01/2025
1		10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M002	02/01/2025

Labeler - CVS PHARMACY, INC (062312574)

Registrant - TIME CAP LABORATORIES, INC. (037052099)

Establishment
Name	Address	ID/FEI	Business Operations
MARKSANS PHARMA LIMITED		925822975	manufacture(51316-621)