Label: COMBINATION REMEDY 26 - SORE THROAT- calcarea fluorica, calcarea phosphorica, hepar sulphuris calcereum, kali iodatum, manganum aceticum solution/ drops

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated December 25, 2017

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  • WARNINGS

    Stop use and ask doctor if symptoms worsen or persist longer than 7 days.

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

    Do not use if tamper evident seal is missing or broken.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • ACTIVE INGREDIENT

    Calcarea Fluorica 6X

    Calcarea Phosphorica 6X

    Hepar Sulphuris Calcereum 6X

    Kali Iodatum 6X

    Manganum Aceticum 6X

  • PURPOSE

    Temporary relief from sore throat, painful swallowing, chills, nausea, difficulty opening mouth.

  • INACTIVE INGREDIENT

    Purified Water

    Alcohol

  • DOSAGE & ADMINISTRATION

    Adults and children 12 years and older: Take 10-15 drops in half cup of water 3 times a day.

    Children 2 years to under 12 years: Take 8-10 drops in half cup of water of 3 times a day.

    Children under 2 years: Consult doctor prior to use.

  • INDICATIONS & USAGE

    Temporary relief from sore throat, painful swallowing, chills, nausea, difficulty opening mouth.

  • PRINCIPAL DISPLAY PANEL

    sore throat combo 26.jpg

  • INGREDIENTS AND APPEARANCE
    COMBINATION REMEDY 26 - SORE THROAT 
    calcarea fluorica, calcarea phosphorica, hepar sulphuris calcereum, kali iodatum, manganum aceticum solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69008-4026
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE6 [hp_X]  in 1 mL
    POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q) POTASSIUM IODIDE6 [hp_X]  in 1 mL
    CALCIUM FLUORIDE (UNII: O3B55K4YKI) (FLUORIDE ION - UNII:Q80VPU408O) CALCIUM FLUORIDE6 [hp_X]  in 1 mL
    TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (PHOSPHATE ION - UNII:NK08V8K8HR) TRIBASIC CALCIUM PHOSPHATE6 [hp_X]  in 1 mL
    MANGANESE ACETATE TETRAHYDRATE (UNII: 9TO51D176N) (MANGANESE CATION (2+) - UNII:H6EP7W5457) MANGANESE ACETATE TETRAHYDRATE6 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69008-4026-120 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product11/16/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic11/15/2017
    Labeler - Warsan Homoeopathic Laboratories (645579772)
    Registrant - Warsan Homoeopathic Laboratories (645579772)
    Establishment
    NameAddressID/FEIBusiness Operations
    Warsan Homoeopathic Laboratories645579772manufacture(69008-4026) , pack(69008-4026) , label(69008-4026)
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