Ultra Strength Gas Relief

Manufacturer
Chain Drug Marketing Association Inc. | Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.
Effective date
2016-07-28
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:46:38

Label at a glance#

ProductUltra Strength Gas Relief
Active ingredientDIMETHICONE
Label structure10 sections

Indications and uses

relieves bloating, pressure or fullness commonly referred to as gas

Dosage and administration

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

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each softgel)

OTC - ACTIVE INGREDIENT SECTION

Simethicone 180 mg

Purpose

OTC - PURPOSE SECTION

Anti-gas

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

OTC - STOP USE SECTION

Stop use and ask a doctor if condition persists

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. 

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

Call: 1-855-215-8180

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Ultra Strength Gas Relief

Simethicone 180 mg Antigas  60 Softgels

NDC 63868-098-60

*Compare to the active ingredient in PHAZYME® Ultra Strength

CDMA Ultra Strength Gas Relief 60ctCDMA Ultra Strength Gas Relief 60ct

CDMA Ultra Strength Gas Relief 60ct-bottleCDMA Ultra Strength Gas Relief 60ct-bottle

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
252294simethicone 180 MG Oral CapsulePSN1
252294simethicone 180 MG Oral CapsuleSCD1
252294dimethicone 180 MG Oral CapsuleSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIMETHICONE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63868-098-602025-01-30C16284748780-12cef2736-8d3a-d83d-e063-dadaa90ab31fUltra Strength Gas Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-098-60Ultra Strength Gas Relief60 in 1 BOTTLECAPSULE, LIQUID FILLED601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-098ULTRA STRENGTH GAS RELIEF (SIMETHICONE) CAPSULE, LIQUID FILLED [CHAIN DRUG MARKETING ASSOCIATION INC.]1Legacy NDC, 1 package rows20160728_01911ad2-063d-4d8c-b6ea-09784b883548.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63868-09863868-098-60

Ingredients#

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

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

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
825a9598-82c0-40d9-85ec-689708dbd7c801911ad2-063d-4d8c-b6ea-09784b8835482016-07-28WarningsExact identifier
spl id: 825a9598-82c0-40d9-85ec-689708dbd7c8
spl set id: 01911ad2-063d-4d8c-b6ea-09784b883548

Reported adverse events (FAERS/openFDA)#

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