FDA.reportPublic FDA data

GAS RELIEF

Manufacturer
STRATEGIC SOURCING SERVICES LLC | Geri-Care Pharmaceuticals, Corp
Effective date
2023-10-26
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-01 21:23:10

Label at a glance#

ProductGAS RELIEF
Active ingredientDIMETHICONE
Label structure9 sections

Indications and uses

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

Dosage and administration

chew or crush tablet completely before swallowing 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

each tablet contains: calcium 65 mg store at room temperature, 15°C - 30°C (59˚F - 86˚F) protect from moisture

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

relieves 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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • chew or crush tablet completely before swallowing
  • 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

  • each tablet contains: calcium 65 mg
  • store at room temperature, 15°C - 30°C (59˚F - 86˚F)
  • protect from moisture

Inactive ingredients

INACTIVE INGREDIENT SECTION

cellulose, corn starch, crospovidone, dextrates hydrated, flavor, magnesium stearate, silica, sucralose, calcium phosphate.

Questions or comments?

OTC - QUESTIONS SECTION

1-800-540-3765

package label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62011-0291-1EA - Each62011-0291d9be07f2-2945-45e3-8fbf-3a64e2461f3312018-03-08

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62011-029162011-0291-1

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
MAGNESIUM STEARATE70097M6I30IACT
STARCH, CORNO8232NY3SJIACT
CALCIUM PHOSPHATE97Z1WI3NDXIACT
SUCRALOSE96K6UQ3ZD4IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
DIMETHICONE92RU3N3Y1OACTIB
DEXTRATESG263MI44RUIACT
CROSPOVIDONE2S7830E561IACT

Source Document#

Source XML · Source PDF

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
08a20c11-01e3-89a2-e063-6294a90ab90840f88c2c-5221-5ca2-e054-00144ff8d46c2023-10-26WarningsExact identifier
spl id: 08a20c11-01e3-89a2-e063-6294a90ab908
spl set id: 40f88c2c-5221-5ca2-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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