Simethicone Anti-Gas

Manufacturer
Synmosa Biopharma Corporation Synmosa Plant
Effective date
2024-01-31
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 21:06:51

Label at a glance#

ProductSimethicone Enteric S.C.
Active ingredientDIMETHICONE
Label structure11 sections

Dosage and administration

Adults and children over 12 years: one or two tablets daily, taken with meal or at bedtime. Do not exceed 8 tablets per day except under the advice and supervision of a physician.

Storage and handling

Store below 25°C (77°F).

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

(in each sugar-coated tablet)

Simethicone 60 mg

Purpose

OTC - PURPOSE SECTION

Anti-gas

Use

INDICATIONS & USAGE SECTION

Relief of bloating and pressure commonly referred to as gas.

Warnings

WARNINGS SECTION

OTC - PREGNANCY OR BREAST FEEDING 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

Adults and children over 12 years: one or two tablets daily, taken with meal or at bedtime.

Do not exceed 8 tablets per day except under the advice and supervision of a physician.

Other information

STORAGE AND HANDLING SECTION

Store below 25°C (77°F).

Inactive ingredients

INACTIVE INGREDIENT SECTION

Calcium Phosphate Dibasic, Carnauba Wax, Corn Starch, FD&C Red No. 3 (Erythrosine), Gelatin, Corn Starch (Pregelatinized), Lactose Monohydrate, Hypromellose Phthalate (31% phthalate, 40 CST), Polyoxyl 40 Stearate, Polysorbate 80, Povidone K-30, Sucrose granules, Sodium Starch Glycolate, Talc, Titanium

OTHER SAFETY INFORMATION

TAMPER EVIDENT

Do not use if blister unit is torn, broken or shows any signs of tampering.

SPL UNCLASSIFIED SECTION

Simethicone Enteric S.C.

Tablets 60 mg

Composition:

Each S.C. tablet contains:

Simethicone . . . . . 60 mg

Anti Gas

Acts Fast to Relieve

  • Gas Pressure
  • Bloating
  • Gas Discomfort

Manufactured by:

Synmosa Biopharma Corporation,Synmosa Plant

No. 6, Kuang Yeh 1 st Road, Hu-Kuo Hsiang

Hsin-Chu Ind. Park, Hsin Chu Hsien

Taiwan, R.O.C.

Made in Taiwan (R.O.C.)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

synmosa

ANTI-GAS

Simethicone Enteric S.C. Tablets 60 mg

Keep outer carton for complete warnings and product information

OTC Anti-Gas Ingredient

100 Tablets

labellabel

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83931-00183931-001-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 15 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
2728a93e-b89a-bc3c-e063-6394a90a9f1310a3e368-acb9-8567-e063-6294a90a4f2e2024-11-17WarningsExact identifier
spl set id: 10a3e368-acb9-8567-e063-6294a90a4f2e

Reported adverse events (FAERS/openFDA)#

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