FDA.reportPublic FDA data

EXTRA STRENGTH GAS RELIEF

Manufacturer
Geri-Care Pharmaceuticals, Corp
Effective date
2021-12-02
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 22:24:59

Label at a glance#

ProductEXTRA STRENGTH GAS 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

adults: swallow with water 1 or 2 capsules as needed after meals and at bedtime do not exceed 4 capsules in 24 hours unless directed by a doctor

Storage and handling

Tamper Evident : Do not use if imprinted seal under cap is missing or broken. Product of China, Packaged and Quality Assured in the USA. store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) protect from light, heat and moisture

Label contents#

Full prescribing information#

Active ingredient (in each liquid-filled capsule)

OTC - ACTIVE INGREDIENT SECTION

Simethicone 125 mg

Purpose

OTC - PURPOSE SECTION

Antigas

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults: swallow with water 1 or 2 capsules as needed after meals and at bedtime
  • do not exceed 4 capsules in 24 hours unless directed by a doctor

Other information

STORAGE AND HANDLING SECTION

  • Tamper Evident: Do not use if imprinted seal under cap is missing or broken.
  • Product of China, Packaged and Quality Assured in the USA.
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • protect from light, heat and moisture

Inactive ingredients

INACTIVE INGREDIENT SECTION

D&C yellow #10, edible white ink, FD&C blue #1, FD&C red #40, gelatin, glycerin, peppermint oil, purified water, titanium dioxide

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
57896-692-052021-02-17C16284748780-1ba0f9c33-2b21-a910-e053-dadaa90a0b85gc792l (692)
57896-692-052021-01-29C16284748780-1ba0f9c33-2b21-a910-e053-dadaa90a0b85gc792l (692)

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57896-692-05EA - Each57896-6926fb80900-a220-45c4-b978-4d8be1502a8712021-03-02

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
57896-69257896-692-05

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
TITANIUM DIOXIDE15FIX9V2JPIACT
WATER059QF0KO0RIACT
DIMETHICONE92RU3N3Y1OACTIB
D&C YELLOW NO. 1035SW5USQ3GIACT
GELATIN2G86QN327LIACT
FD&C RED NO. 40WZB9127XOAIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
GLYCERINPDC6A3C0OXIACT
PEPPERMINT OILAV092KU4JHIACT

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
d22f6425-9a77-9d0f-e053-2a95a90a623699eaebfe-45c3-b3b6-e053-2995a90a03342021-12-02WarningsExact identifier
spl id: d22f6425-9a77-9d0f-e053-2a95a90a6236
spl set id: 99eaebfe-45c3-b3b6-e053-2995a90a0334

Reported adverse events (FAERS/openFDA)#

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