FDA.reportPublic FDA data

Extra Strength Gas Relief Tablets

Manufacturer
Retail Business Services, LLC. | Guardian Drug Company
Effective date
2018-09-28
Label type
Human OTC Drug Label
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:33:25

Label at a glance#

ProductCareone Extra Strength Gas Relief
Active ingredientDIMETHICONE
Label structure9 sections

Dosage and administration

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

Storage and handling

do not use if any individual blister unit is broken or open store at room temperature avoid high humidity and excessive heat, above 40ºC (104ºF)

Label contents#

Full prescribing information#

ACTIVE INGREDIENT(in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Simethicone 125 mg

PURPOSE

OTC - PURPOSE SECTION

Anti-gas

USE(S)

INDICATIONS & USAGE SECTION

relieves:

  • pressure
  • bloating
  • symptoms referred to as gas

WARNINGS

WARNINGS SECTION

.

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a poison control center immediately.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

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

OTHER INFORMATION

STORAGE AND HANDLING SECTION

  • do not use if any individual blister unit is broken or open
  • store at room temperature
  • avoid high humidity and excessive heat, above 40ºC (104ºF)

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

D&C red # 30 aluminum lake, dextrose, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, sorbitol, sucrose

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 72476-019-73

Careone

Compare to the Active Ingredient in Gas-X® Chewables Extra Strength*
EXTRA STRENGTH
GAS RELIEF
Simethicone 125 mg - Anti-Gas

Cherry Creme
FAST RELIEF OF:

  • DISCOMFORT FROM GAS
  • BLOATING
  • PRESSURE

 

18 chewable tablets
102102

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72476-01972476-019-73

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIMETHICONE92RU3N3Y1OACTIB
D&C RED NO. 302S42T2808BIACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
SORBITOL506T60A25RIACT
SUCROSEC151H8M554IACT
MALTODEXTRIN7CVR7L4A2DIACT
DEXTROSE, UNSPECIFIED FORMIY9XDZ35W2IACT

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
6edd5d7c-56a8-4b26-8e34-b771f772f99dcdc0a023-65a0-4ec8-a4bb-44a0043c5f5e2024-12-11WarningsExact identifier
spl set id: cdc0a023-65a0-4ec8-a4bb-44a0043c5f5e

Reported adverse events (FAERS/openFDA)#

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