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 March 22, 2022
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- Official Label (Printer Friendly)
- Active Ingedients
- Inactive Ingredient
- Purpose
- Indications and Usage
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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
- Stop Use
- Pregnancy or Breast Feeding
- Keep out of reach of children
- Overdose
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ALPHA SH
sanguinaria canadensis root, goldenseal, silicon dioxide, potassium chloride, pulsatilla vulgaris tabletProduct 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 01/31/2027 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 01/31/2027 Labeler - Schwabe North America, Inc. (831153908) Establishment Name Address ID/FEI Business Operations Schwabe Mexico, S.A. de C.V. 812805901 manufacture(53499-1391)