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

  • NDC Code(s): 53499-1391-1
  • Packager: Schwabe North America, Inc.
  • 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 October 18, 2021

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

  • Active Ingedients

    Hydrastis canadensis 6X

    Kali muriaticum 3X

    Pulsatilla 6X

    Sanguinaria canadensis 6X

    Silicea 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 and 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 under tongue at least 15 minutes before or 30 minutes after eating, brushing teeth or drinking anything except water.

    Adults and Children 12 years and over: Take 2 tablets every 2 hours until relieved

    Children 6-12 years of age: take 1 tablet every 2 hours until relieved

    Children under 6 years of age: 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 you are 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 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:53499-1391
    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:53499-1391-14 in 1 BOX08/18/2011
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic08/18/2011
    Labeler - Schwabe North America, Inc. (831153908)
    Establishment
    NameAddressID/FEIBusiness Operations
    Schwabe Mexico, S.A. de C.V.812805901manufacture(53499-1391)