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 June 28, 2018

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

  • ACTIVE INGREDIENT

    Inactive Ingredients

    Microcrystalline cellulose

    lactose monohydrate

    magnesium sterate

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  • INACTIVE INGREDIENT

    INACTIVE INGREDIENT:

    Lactose monohydrate

    Magnesium stearate

    Microcrystalline cellulose

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  • PURPOSE

    PURPOSE:

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

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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of the reach of children.

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  • INDICATIONS & USAGE

    INDICATIONS AND USAGE:

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

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  • 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.

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  • DOSAGE & ADMINISTRATION

    DOSAGE:

    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.

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  • PREGNANCY OR BREAST FEEDING

    Pregnancy or Breast Feeding:

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

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  • OVERDOSAGE

    Overdosage:

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

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  • 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.

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  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Boericke and Tafel Alpha SH 21801390 40 tablets

    AAlpha SH_A01

    Alpha SH-A01.jpg

    Alpha SH-A01.jpg

    Alpha SH-A01.jpg

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  • INGREDIENTS AND APPEARANCE
    ALPHA SH 
    sanguinaria canadensis root, goldenseal, silicon dioxide, potassium chloride, pulsatilla vulgaris tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:53499-1391
    Route of Administration SUBLINGUAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SANGUINARIA CANADENSIS ROOT (UNII: N9288CD508) (SANGUINARIA CANADENSIS ROOT - UNII:N9288CD508) SANGUINARIA CANADENSIS ROOT 6 [hp_X]
    GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL 6 [hp_X]
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE 6 [hp_X]
    POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152) POTASSIUM CHLORIDE 3 [hp_X]
    PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV) PULSATILLA VULGARIS 6 [hp_X]
    Inactive Ingredients
    Ingredient Name Strength
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    Product Characteristics
    Color white (B;T) Score no score
    Shape ROUND (B;T) Size 8mm
    Flavor Imprint Code B;T
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:53499-1391-1 4 in 1 BOX 08/18/2011
    1 10 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved homeopathic 08/18/2011
    Labeler - Schwabe North America, Inc. (831153908)
    Establishment
    Name Address ID/FEI Business Operations
    Schwabe Mexico, S.A. de C.V. 812805901 manufacture(53499-1391)
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