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

  • NDC Code(s): 68466-3191-1
  • 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 December 3, 2019

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

  • ACTIVE INGREDIENT

    Hydraetis canadensis 6X, Keli muriaticum 3X, Pulsatilla 6X, SANGUINARIA CANADENSIS 6X, Silcea 6X

  • INACTIVE INGREDIENT

    INACTIVE INGREDIENT:

    Lactose monohydrate

    Magnesium stearate

    Microcrystalline cellulose

  • PURPOSE

    PURPOSE:

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

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • INDICATIONS & USAGE

    INDICATIONS AND USAGE:

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

  • WARNINGS

    WARNINGS:

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

    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.

  • DOSAGE & ADMINISTRATION

    Directions:

    Sublingual medication. Place tablets under tongue at least 15 minutes before or half hour after eating, brushing teeth, or drinking anything except water.

    Adults and children 12 years of age and older:

    take 2 tablets every two hours until relieved.

    Children 2 to 12:

    take 1 every two hours until relieved

    Children under 2:

    Consult a physician.

  • PREGNANCY OR BREAST FEEDING

    Pregnancy or Breast Feeding:

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

  • OVERDOSAGE

    Overdosage:

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

  • ASK DOCTOR

    Ask the Doctor:

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

    Stop use and ask a doctor if symptoms persist, get worse, or are accompanied by a high fever, or if new symptoms occur.

    These could be signs of a serious condition.

  • PRINCIPAL DISPLAY PANEL

    Alpha SH_A01.jpgAlpha 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:68466-3191
    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 VULGARIS3 [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:68466-3191-14 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 Mexico, S.A. de C.V. (812805901)
    Establishment
    NameAddressID/FEIBusiness Operations
    Schwabe Mexico, S.A. de C.V.812805901manufacture(68466-3191)