FDA.reportPublic FDA data

Simethicone 80 mg

Manufacturer
REMEDYREPACK INC.
Effective date
2021-06-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:43:28

Label at a glance#

ProductSimethicone 80 mg
Active ingredientDIMETHICONE
Label structure13 sections

Dosage and administration

thoroughly chew 1-2 tablets as needed after meals and at bedtime do not take more then 6 tablets per day

Storage and handling

store at room temperature 15°-30°C (59°-86°F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Use

INDICATIONS & USAGE SECTION

relieves bloating, pressure and fullness commonly referred to as gas

Warnings

WARNINGS SECTION

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

Directions

DOSAGE & ADMINISTRATION SECTION

  • thoroughly chew 1-2 tablets as needed after meals and at bedtime
  • do not take more then 6 tablets per day

Other information

STORAGE AND HANDLING SECTION

store at room temperature 15°-30°C (59°-86°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

compressible sugar, dextrose, maltodextrin, micdocrystalline cellulose, peppermint flavor, Silicon dioxide, sorbitol, stearic acid

Questions or comments?

OTC - QUESTIONS SECTION

call 516-341-0666, 8:30 am to 4:30 pm ET, Monday - Friday

SPL UNCLASSIFIED SECTION

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

SPL UNCLASSIFIED SECTION

Repackaged and Distributed By:

Remedy Repack, Inc.

625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Active ingredient (in each chewable tablet)

OTC - ACTIVE INGREDIENT SECTION

Simethicone 80 mg

Purpose

OTC - PURPOSE SECTION

Antiflatulent

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DRUG: Simethicone 80 mg

GENERIC: Simethicone

DOSAGE: TABLET, CHEWABLE

ADMINSTRATION: ORAL

NDC: 70518-3123-0

NDC: 70518-3123-1

COLOR: white

SHAPE: ROUND

SCORE: No score

SIZE: 13 mm

IMPRINT: AP;019

PACKAGING: 1 in 1 POUCH

OUTER PACKAGING: 100 in 1 BOX

ACTIVE INGREDIENT(S):

  • DIMETHICONE 80mg in 1

INACTIVE INGREDIENT(S):

  • CELLULOSE, MICROCRYSTALLINE
  • SILICON DIOXIDE
  • MALTODEXTRIN
  • SORBITOL
  • STEARIC ACID
  • SUCROSE
  • DEXTROSE
  • PEPPERMINT

Remedy_LabelRemedy_Label

MM2MM2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70518-3123-02025-09-11C16284748780-1f386c649-ca2e-0266-e053-dadaa90a7c1aSimethicone 80 mg
70518-3123-02023-01-30C16284748780-1f386c649-ca2e-0266-e053-dadaa90a7c1aSimethicone 80 mg

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3123SIMETHICONE 80 MG (SIMETHICONE) TABLET, CHEWABLE [REMEDYREPACK INC.]1Legacy NDC20210616_7eb8428b-83c1-4ea3-82da-3c2f4fcc39cb.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69618-033-01EA - Each69618-033528ab526-0fb6-4940-b880-185c047213a312016-06-14

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
70518-312370518-3123-1, 70518-3123-0
69618-033

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
SILICON DIOXIDEETJ7Z6XBU4IACT
MALTODEXTRIN7CVR7L4A2DIACT
SORBITOL506T60A25RIACT
STEARIC ACID4ELV7Z65APIACT
SUCROSEC151H8M554IACT
DEXTROSEIY9XDZ35W2IACT
PEPPERMINTV95R5KMY2BIACT
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
Simethicone 80 mgSIMETHICONEReliable 1 Laboratories LLC32fb242b-7051-072c-e054-00144ff88e882025-01-15WarningsExact identifier
ndc (product): 69618-033
05a7f37c-86fa-b889-e063-6394a90a8b9c7eb8428b-83c1-4ea3-82da-3c2f4fcc39cb2023-09-18WarningsExact identifier
spl set id: 7eb8428b-83c1-4ea3-82da-3c2f4fcc39cb

Reported adverse events (FAERS/openFDA)#

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