FDA.reportPublic FDA data

TopCare® Extra Strength Gas Relief 48 Chewable Tablets

Manufacturer
TOPCO ASSOCIATES LLC
Effective date
2025-11-10
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 01:43:07

Label at a glance#

ProductTopCare Extra Strength Gas Relief Cherry Creme
Active ingredientDIMETHICONE, UNSPECIFIED
Label structure9 sections

Indications and uses

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

Dosage and administration

adults: chew 1 to 2 tablets as needed after meals and at bedtime do not exceed 4 tablets in 24 hour except under the advice and supervision of a physician

Storage and handling

each tablet contains: calcium 45 mg store at room temperature protect from excessive heat and moisture

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Simethicone 125 mg

Purpose

OTC - PURPOSE SECTION

Anti-gas

Uses

INDICATIONS & USAGE SECTION

Foe the relief of

  • pressure, bloating and fullness commonly referred to as gas

Warnings

WARNINGS SECTION

Keep Out of Reach of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults:chew 1 to 2 tablets as needed after meals and at bedtime
  • do not exceed 4 tablets in 24 hour except under the advice and supervision of a physician

Other information

STORAGE AND HANDLING SECTION

  • each tablet contains:calcium 45 mg
  • store at room temperature
  • protect from excessive heat and moisture

Inactive ingredients

INACTIVE INGREDIENT SECTION

D&C Red No. 30, dextrose, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, silica, sucralose, tribasic calcium phosphate

Questions or comments?

OTC - QUESTIONS SECTION

1-866-467-2748

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 36800-488-48

COMPARE TO GAS-X®E XTRA STRENGTH ACTIVE INGREDIENT*

EXTRA STRENGTH

Gas Relief

ANTIGAS/SIMETHICONE 125 mg

  • FOR FAST RELIEF OF
  • Bloating
  • Pressure
  • Discomfort of Gas

CHERRY CREME FLAVOR

Naturally and Artificially Flavored

48 CHEWABLE TABLETS

DO NOT USE IF PRINTED INNER SEAL IS BROKEN OR MISSING

DISTRIBUTED BY: TOPCO ASSOCIATES LLC,

ELK GROVE VILLAGE, IL 60007

© TOPCO RARA1217

QUESTIONS? 1-888-423-0139

topcare@topco.com, www.topcarebrand.com

*This product is not manufactured or distributed by GSK Consumer Healthcare, Inc., the distributor of GAS-X® Extra Strength.

TopCare Extra Strength Simethicone 48 Chewable Tablets
TopCare Extra Strength Simethicone 48 Chewable Tablets

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
314221simethicone 125 MG Chewable TabletPSN7
314221simethicone 125 MG Chewable TabletSCD7

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130036800462878GTIN-13: 0036800462878
EAN-13: 0036800462878
GTIN-12: 036800462878
UPC-A: 036800462878
GTIN storage (14 digits): 00036800462878		WC134CHR.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-488-48TopCare Extra Strength Gas ReliefCherry Creme48 in 1 BOTTLE, PLASTICTABLET, CHEWABLE487

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
36800-48836800-488-48

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
D&C RED NO. 302S42T2808BIACT
DEXTROSE, UNSPECIFIED FORMIY9XDZ35W2IACT
MAGNESIUM STEARATE70097M6I30IACT
MALTODEXTRIN7CVR7L4A2DIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SUCRALOSE96K6UQ3ZD4IACT
TRIBASIC CALCIUM PHOSPHATE91D9GV0Z28IACT
DIMETHICONE, UNSPECIFIED92RU3N3Y1OACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
62024-11-06full-release2026-06-01 00:34:28

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
TopCare Extra Strength Gas Relief Cherry CremeSIMETHICONETOPCO ASSOCIATES LLC4d1701fd-b797-4e95-9004-84d528941e722025-11-10WarningsExact identifier
ndc (package): 36800-488-48
ndc (product): 36800-488
ndc11 (package): 36800048848
spl id: 433a62cb-23ea-bbb3-e063-6294a90ac883
spl set id: 4d1701fd-b797-4e95-9004-84d528941e72

Reported adverse events (FAERS/openFDA)#

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