GAS RELIEF

Manufacturer
Geri-Care Pharmaceuticals, Corp
Effective date
2023-10-26
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:23:15

Label at a glance#

ProductGAS RELIEF
Active ingredientDIMETHICONE
Label structure9 sections

Indications and uses

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

Dosage and administration

• chew thoroughly • adults and children 12 years and over: take 1-2 tablets as needed after meals and at bedtime. Do not exceed 6 tablets in 24 hours except under the advice and supervision of a doctor. • children under 12 years: ask a doctor

Storage and handling

Tamper Evident: Do not use if imprinted seal under cap is missing or broken store at room temperature, 15°C - 30°C (59˚F - 86˚F)

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Simethicone 80 mg

Purpose

OTC - PURPOSE SECTION

Anti-Gas

Uses

INDICATIONS & USAGE SECTION

for the relief of

  • pressure, bloating, and fullness commonly referred to as gas

Warnings

WARNINGS SECTION

If pregnant or breast feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

• chew thoroughly
• adults and children 12 years and over: take 1-2
tablets as needed after meals and at bedtime. Do
not exceed 6 tablets in 24 hours except under the
advice and supervision of a doctor.
• children under 12 years: ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • Tamper Evident: Do not use if imprinted seal under cap is missing or broken
  • store at room temperature, 15°C - 30°C (59˚F - 86˚F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

dextrose, sugar, maltodextrin, microcrystalline cellulose, peppermint flavor, silica, sorbitol, stearic acid

Questions or comments?

OTC - QUESTIONS SECTION

1-800-540-3765

package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57896-799-012022-12-15C16284748780-1d6a99b39-ce33-a426-e053-dadaa90af4c2gc 791a (799)
57896-799-082022-12-15C16284748780-1d6a99b39-ce33-a426-e053-dadaa90af4c2gc 791a (799)
57896-799-012022-01-28C16284748780-1d6a99b39-ce33-a426-e053-dadaa90af4c2gc 791a (799)
57896-799-082022-01-28C16284748780-1d6a99b39-ce33-a426-e053-dadaa90af4c2gc 791a (799)

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57896-799GAS RELIEF (SIMETHICONE) TABLET, CHEWABLE [GERI-CARE PHARMACEUTICALS, CORP]3Legacy NDC20231027_b66f63d0-be82-a75b-e053-2a95a90a3f13.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57896-799-01EA - Each57896-799a4b10310-54df-455c-a2da-6bb896ac436c12021-03-02
57896-799-08EA - Each57896-799a719d384-226d-4303-9d1b-b9b42aa318d812021-01-08

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
57896-79957896-799-01, 57896-799-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 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
45756704-0062-5ac1-e063-6294a90a6734b66f63d0-be82-a75b-e053-2a95a90a3f132025-12-08WarningsExact identifier
spl set id: b66f63d0-be82-a75b-e053-2a95a90a3f13

Reported adverse events (FAERS/openFDA)#

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