MedPath

Curist Gas Relief

Approved
Approval ID

3948c0e5-4ee7-5443-e063-6294a90ad6ae

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Jul 6, 2025

Manufacturers
FDA

Little Pharma. Inc.

DUNS: 074328189

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 Code72559-041
Application NumberM002
Product Classification
M
Marketing Category
C200263
G
Generic Name
Simethicone
Product Specifications
Route of AdministrationORAL
Effective DateJuly 6, 2025
FDA Product Classification

INGREDIENTS (8)

TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
DIMETHICONEActive
Quantity: 180 mg in 180 mg
Code: 92RU3N3Y1O
Classification: ACTIB
GELATINInactive
Code: 2G86QN327L
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 7/31/2025

curist

Gas Relief

Simethicone 180 mg

Anti-Gas

Relief of Gas, Pressure, Bloating, and Fullness

365 Softgels

gas relief

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 7/31/2025

Use

Relieves pressure, bloating, or fullness commonly referred to as gas

WARNINGS SECTION

LOINC: 34071-1Updated: 7/31/2025

Warnings

Stop use and ask doctor if condition persists

If pregant or breast feeding, ask a health profession before use

Keep out of reach of children

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 7/31/2025

Active Ingredient (in each softgel)

Simethicone 180 mg

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 7/31/2025

** Other information**

Store at room temperature 20-25°C (68-77°F)

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 7/31/2025

Distrbuted by:

Little Pharma, Inc.

New York, NY 10023

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 7/31/2025

Purpose

Antigas

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 7/31/2025

Directions

  • Adults: Swallow 1 or 2 softgels with at least 8 oz of water, as needed after a meal or at bedtime.
  • Do not eceed 2 softgels in 24 hours except under the advice and supervision of a physician.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 7/31/2025

Inactive ingredients FD&C Yellow No. 6, gelatin, glycerin, hypromellose, lecithin, titanium dioxide, water

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 7/31/2025

Questions or Comments?

Call1-800-243-1241or email hi@curistrelief.com

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