Simethicone

Manufacturer: AMZ789 LLC | Humanwell Puracap Pharmaceuticals (Wuhan) Co., Ltd
Effective date: 2025-01-08
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: full-release
Hydrated at: 2026-06-01 00:51:34

Label at a glance#

ProductSimethicone

Active ingredientDIMETHICONE

Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Simethicone 180mg

OTC - PURPOSE SECTION

relieves bloating, pressure, fullness, commonly referred to as gas

WARNINGS SECTION

OTC - STOP USE SECTION

stop use and ask a doctor if condition persists

OTC - PREGNANCY OR BREAST FEEDING SECTION

if pregnant or breast-feedingm ask a health professional before use

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

DOSAGE & ADMINISTRATION SECTION

▪ swallow one or two softgels as needed after a meal

▪ do not exceed two softgels per day except under the advice and supervision of a physician

INDICATIONS & USAGE SECTION

Uses relieves ▪ bloating ▪ pressure ▪ fullness commonly referred to as gas

INACTIVE INGREDIENT SECTION

FD&C yellow #6, gelatin, glycerin, purified water, sorbitol

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

RxZell

Fast Acting Gas Relief

Package Label Principle Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
252294	simethicone 180 MG Oral Capsule	PSN	4
252294	simethicone 180 MG Oral Capsule	SCD	4
252294	dimethicone 180 MG Oral Capsule	SY	4

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
DIMETHICONE Pharmacologic Class Indexing	3	Indexing - Pharmacologic Class	20180813

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
73629-002-18	2023-05-28	C162847	48780-1	e4f33bdf-a050-d8a0-e053-dadaa90a6e4e	Simethicone 180mg
73629-002-18	2022-07-29	C162847	48780-1	e4f33bdf-a050-d8a0-e053-dadaa90a6e4e	Simethicone 180mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
73629-002-18	Simethicone	180 in 1 BOTTLE	CAPSULE, LIQUID FILLED	180		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
73629-002	SIMETHICONE CAPSULE, LIQUID FILLED [AMZ789 LLC]	4	Current NDC, Legacy NDC, 1 package rows	20250110_bfaaf4e0-ff87-0fb9-e053-2a95a90a5aa2.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 6 matching rows.

Simethicone
DIMETHICONE
WATER
GLYCERIN
FD&C YELLOW NO. 6
GELATIN

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
73629-002	73629-002-18

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
DIMETHICONE	92RU3N3Y1O	ACTIB
WATER	059QF0KO0R	IACT
GLYCERIN	PDC6A3C0OX	IACT
FD&C YELLOW NO. 6	H77VEI93A8	IACT
GELATIN	2G86QN327L	IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Simethicone	SIMETHICONE	AMZ789 LLC	bfaaf4e0-ff87-0fb9-e053-2a95a90a5aa2	2025-01-08	Warnings	Exact identifier ndc (package): 73629-002-18 ndc (product): 73629-002 ndc11 (package): 73629000218 spl id: 2b3b1754-50af-4089-e063-6294a90a4e75 spl set id: bfaaf4e0-ff87-0fb9-e053-2a95a90a5aa2

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.