Label: ALPHA SH- sanguinaria canadensis root, goldenseal, silicon dioxide, potassium chloride, pulsatilla vulgaris tablet

  • NDC Code(s): 68466-4191-1
  • Packager: Schwabe Mexico, S.A. de C.V.
  • 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 March 22, 2022

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  • Active Ingredient

    Hydraetis canadensis 6X

    Kali muriaticum 3X

    Pulsatilla 6X

    Sanguinaria canadensis 6X

    Silcea 6X

  • INACTIVE INGREDIENT

    Cellulose

    Lactose monohydrate

    Magnesium stearate

  • Purpose

    Temporarily relieves these symptoms: helps decongest sinus openings and passages, shrinks swollen nasal membranes and promotes sinus drainage.

  • Indications & Usage

    Temporarily relieves these symptoms: helps decongest sinus openings and sinus passages, shrinks swollen nasal membranse, promotes sinus drainage.

  • Dosage & Administration

    Directions:
    Sublingual medication. Place tablets under tongue at least 15 minutes before or 30m minutes after eating, brushing teeth, or drinking anything except water.
    Adults and children 12 years of age and older: Take 2 tablets every 2 hours until relieved.
    Children 2 to 12: Take 1 every 2 hours until relieved
    Children under 2: Consult a physician.

  • Warnings

    Do not use this product for headache pain for more than 10 days (for adults) or 5 days (for children).

  • Stop use

    Stop use and ask a doctor if symptoms persist, get worse, or are accompanied by a high fever, or if new symptoms occur.
    These can be signs of a serious condition.

  • Pregnancy or Breast Feeding

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

  • Keep out of reach of children

    Keep out of reach of children

  • Overdose

    In case of overdose, seek medical help or contact a Poison Control Center immediately. 

  • PRINCIPAL DISPLAY PANEL

    Alpha SH_A01.jpg

  • INGREDIENTS AND APPEARANCE
    ALPHA SH 
    sanguinaria canadensis root, goldenseal, silicon dioxide, potassium chloride, pulsatilla vulgaris tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68466-4191
    Route of AdministrationSUBLINGUAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SANGUINARIA CANADENSIS ROOT (UNII: N9288CD508) (SANGUINARIA CANADENSIS ROOT - UNII:N9288CD508) SANGUINARIA CANADENSIS ROOT6 [hp_X]
    GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL6 [hp_X]
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE6 [hp_X]
    POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152) POTASSIUM CHLORIDE3 [hp_X]
    PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV) PULSATILLA VULGARIS6 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    Product Characteristics
    Colorwhite (B;T) Scoreno score
    ShapeROUND (B;T) Size8mm
    FlavorImprint Code B;T
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68466-4191-14 in 1 BOX10/16/202001/31/2027
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic10/16/202001/31/2027
    Labeler - Schwabe Mexico, S.A. de C.V. (812805901)
    Establishment
    NameAddressID/FEIBusiness Operations
    Schwabe Mexico, S.A. de C.V.812805901manufacture(68466-4191)
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