Label: DR SIMI MUCUS RELIEF EXPECTORANT- guaifenesin tablet, extended release

  • NDC Code(s): 85786-301-14
  • Packager: Farmacias De Similares TX LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated August 15, 2025

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  • Drug Facts

    Active ingredient (in each extended-release tablet)

    • Guaifenesin 1200 mg

  • Purpose

    Purpose

    • Expectorant
  • Uses

    • Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.
  • Warnings

    Warnings

    Do not use

    • For children under 12 years of age.

    Ask a doctor before use if you have

    • Persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema.
    • Cough accompained by too much phlegm (mucus).

    Stop use and ask a doctor if

    • Cough lasts more than 7 days, come back, or occurs with fever, rash or persistent headache. These could be signs of a serious illness.

    If pregnant or breast-feeding

    ask a health professional before use

    Keep out of reach of children

    ​Keep out of reach of children

    Overdosage

    in case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • Directions

    • Do not crush, chew, or break tablet.
    • Take with a full glass of water.
    • This product can be administered without regard for timing of meals.

    • Adults and children 12 years of age and over: 1 tablet every 12 hours. Do not exceed 2 tablets in 24 hours.
    • Childrens under 12 years of age: do not use.
  • Other information

    • Store between 20-25°C (68-77°F)
    • TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
  • Inactive ingredients

    Carbomer homopolymer type B, Hypromellose, Magnesium stearate, Microcrystalline cellulose, Sodium starch glycolate.

  • Questions or comments?

    (855)-280-1079

  • SPL UNCLASSIFIED SECTION

    Distributed by: FARMACIAS DE SIMILARES TX LLC
    800 Brazos St Ste 260, Austin, TX, 78701, USA.
    customerservice@drsimi.com
    www.drsimi.com
    LOT#

    EXP:

    PEEL BACK for more DRUG FACTS

  • PRINCIPAL DISPLAY PANEL

    DR SIMI

    NDC 85786-301-14

    Maximum Strength / Expectorant

    Mucus Relief

    Guaifenesin 1200 mg

    Relieves Chest Congestion

    Thins and Loosens Mucus

    Immediate and Extended Release

    14 Tablets

    Extended Release

    Bi-Layer Tablets

    PDPTDF

  • INGREDIENTS AND APPEARANCE
    DR SIMI MUCUS RELIEF EXPECTORANT 
    guaifenesin tablet, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:85786-301
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN1200 mg
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM STARCH GLYCOLATE TYPE B (UNII: SP4S77AHO6)  
    CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL OR ALLYL SUCROSE CROSSLINKED) (UNII: K6MOM3T5YL)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeOVALSize21mm
    FlavorImprint Code G;1200
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:85786-301-1414 in 1 BOTTLE; Type 0: Not a Combination Product08/15/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01208/15/2025
    Labeler - Farmacias De Similares TX LLC (119489934)
    Establishment
    NameAddressID/FEIBusiness Operations
    Granules India Limited918609236analysis(85786-301) , label(85786-301) , manufacture(85786-301) , pack(85786-301)
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