MedPath

Gas Relief

Drug Facts

Approved
Approval ID

4ff77b4c-9616-4341-9bf8-eca301345a5f

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 3, 2025

Manufacturers
FDA

CVS PHARMACY, INC

DUNS: 062312574

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Simethicone

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code51316-597
Application NumberM016
Product Classification
M
Marketing Category
C200263
G
Generic Name
Simethicone
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 3, 2025
FDA Product Classification

INGREDIENTS (12)

DIMETHICONEActive
Quantity: 125 mg in 1 1
Code: 92RU3N3Y1O
Classification: ACTIB
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
PEPPERMINT OILInactive
Code: AV092KU4JH
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SORBITANInactive
Code: 6O92ICV9RU
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/3/2025

Product Label

![Simethicone 125 mg](/dailymed/image.cfm?name=gas- relief-125-mg-1.jpg&id=895946)

CVS HEALTH Extra Strength Gas Relief

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 9/3/2025

Uses

For the relief of pressure, bloating, and fullness commonly referred to as gas.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 9/3/2025

Active ingredient (in each softgel)

Simethicone 125 mg

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 9/3/2025

Purpose

Antigas

WARNINGS SECTION

LOINC: 34071-1Updated: 9/3/2025

Warnings

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 9/3/2025

Directions

  • adults: swallow with water 1 or 2 softgels as needed after meals and at bedtime
  • do not exceed 4 softgels in 24 hours except under the advice and supervision of a physician

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 9/3/2025

Other information

  • store between 20-25°C (68-77°F)
  • do not refrigerate
  • protect from light, heat, and moisture

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 9/3/2025

Inactive ingredients

D&C yellow #10, edible ink, FD&C blue #1, FD&C red #40, gelatin, glycerin, mannitol, peppermint oil, purified water, sorbitan, sorbitol, titanium dioxide

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 9/3/2025

Questions or comments?

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