FDA.reportPublic FDA data

SIMETHICONE

Manufacturer
REMEDYREPACK INC.
Effective date
2021-10-13
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:33:25

Label at a glance#

ProductSIMETHICONE
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 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 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
  • 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

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.PRINCIPAL DISPLAY PANEL

DRUG: SIMETHICONE

GENERIC: Simethicone

DOSAGE: TABLET, CHEWABLE

ADMINSTRATION: ORAL

NDC: 70518-3235-0

COLOR: white

FLAVOR: PEPPERMINT

SHAPE: ROUND

SCORE: No score

SIZE: 13 mm

IMPRINT: 44;137

PACKAGING: 30 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

  • DIMETHICONE 80mg in 1

INACTIVE INGREDIENT(S):

  • CELLULOSE, MICROCRYSTALLINE
  • DEXTRATES
  • SILICON DIOXIDE
  • TRICALCIUM PHOSPHATE
  • STARCH, CORN
  • CROSPOVIDONE
  • MAGNESIUM STEARATE
  • SUCRALOSE

Remedy_LabelRemedy_Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70518-3235-02023-10-16C16284748780-1f386c649-bfff-0266-e053-dadaa90a7c1agc 791
70518-3235-02023-01-30C16284748780-1f386c649-bfff-0266-e053-dadaa90a7c1agc 791

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57896-791-01EA - Each57896-791d7abb991-f273-4ad8-8ac3-e1239c002ec012014-12-01
57896-791-08EA - Each57896-791c9e325d9-2782-4318-861b-0e093f6d3dfd12022-02-07

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
70518-323570518-3235-0
57896-791

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
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
DEXTRATESG263MI44RUIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
TRICALCIUM PHOSPHATEK4C08XP666IACT
STARCH, CORNO8232NY3SJIACT
CROSPOVIDONE2S7830E561IACT
MAGNESIUM STEARATE70097M6I30IACT
SUCRALOSE96K6UQ3ZD4IACT
DIMETHICONE92RU3N3Y1OACTIB

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SIMETHICONESIMETHICONEGeri-Care Pharmaceuticals, Corpbe96ce05-dd74-4915-9a8f-2a1b34e2f1582025-11-17WarningsExact identifier
ndc (product): 57896-791
07d7a1a4-e4fe-f804-e063-6294a90a3912e45212ca-2dab-47f1-8815-554751e8dddd2023-10-16WarningsExact identifier
spl set id: e45212ca-2dab-47f1-8815-554751e8dddd

Reported adverse events (FAERS/openFDA)#

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