EXTRA STRENGTH GAS RELIEF

Manufacturer
Geri-Care Pharmaceuticals, Corp
Effective date
2025-04-28
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:16:48

Label at a glance#

ProductEXTRA STRENGTH GAS 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 4 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) protect from moisture

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Simethicone 125 mg

Purpose

OTC - PURPOSE SECTION

Antigas

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 4 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)
  • protect from moisture

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
314221simethicone 125 MG Chewable TabletPSN4
314221simethicone 125 MG Chewable TabletSCD4

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-130357896694036GTIN-13: 0357896694036
EAN-13: 0357896694036
GTIN-12: 357896694036
UPC-A: 357896694036
GTIN storage (14 digits): 00357896694036
694.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57896-694-032022-12-15C16284748780-1d6a99b39-9a3e-a426-e053-dadaa90af4c2GC 694
57896-694-032022-01-28C16284748780-1d6a99b39-9a3e-a426-e053-dadaa90af4c2GC 694

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57896-694-03EXTRA STRENGTH GAS RELIEF30 in 1 BOTTLETABLET, CHEWABLE304

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57896-694-03EA - Each57896-694bae3382b-6d54-4397-994d-fc84239fc58a12021-01-08

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
57896-69457896-694-03

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
EXTRA STRENGTH GAS RELIEFSIMETHICONEGeri-Care Pharmaceuticals, Corpb6223134-8a2e-d1ec-e053-2995a90a90772025-04-28WarningsExact identifier
ndc (package): 57896-694-03
ndc (product): 57896-694
ndc11 (package): 57896069403
spl id: 33da3116-9098-6158-e063-6294a90aed1f
spl set id: b6223134-8a2e-d1ec-e053-2995a90a9077

Reported adverse events (FAERS/openFDA)#

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