Label: SIMETHICONE ENTERIC S.C.- simethicone tablet, sugar coated

  • NDC Code(s): 83931-001-01
  • Packager: Synmosa Biopharma Corporation Synmosa Plant
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 31, 2024

If you are a consumer or patient please visit this version.

View All Sections
  • Drug Facts

  • Active ingredient

    (in each sugar-coated tablet)

    Simethicone 60 mg

  • Purpose

    Anti-gas

  • Use

    Relief of bloating and pressure commonly referred to as gas.

  • Warnings

    If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children.

  • Directions

    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

    Store below 25°C (77°F).

  • Inactive ingredients

    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

  • Questions or comments?

    https://www.synmosa.com.tw/en/Inquiry/ugC_Inquiry.asp

  • 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.)

  • 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

    label

  • INGREDIENTS AND APPEARANCE
    SIMETHICONE ENTERIC S.C. 
    simethicone tablet, sugar coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83931-001
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE60 mg
    Inactive Ingredients
    Ingredient NameStrength
    POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I)  
    FD&C RED NO. 3 (UNII: PN2ZH5LOQY)  
    HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST) (UNII: G4U024CQK6)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SUCROSE (UNII: C151H8M554)  
    CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
    TALC (UNII: 7SEV7J4R1U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    POVIDONE K30 (UNII: U725QWY32X)  
    TITANIUM (UNII: D1JT611TNE)  
    SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GELATIN (UNII: 2G86QN327L)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeROUNDSize11mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83931-001-0110 in 1 BOX04/01/2024
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00204/01/2024
    Labeler - Synmosa Biopharma Corporation Synmosa Plant (657895530)
    Establishment
    NameAddressID/FEIBusiness Operations
    Synmosa Biopharma Corporation Synmosa Plant657895530manufacture(83931-001)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!