FDA.reportPublic FDA data

ALPHA SH

Manufacturer
Schwabe North America, Inc. | Schwabe Mexico, S.A. de C.V.
Effective date
2022-03-22
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
full-release
Hydrated at
2026-06-01 02:17:12

Label at a glance#

ProductALPHA SH
Active ingredientSANGUINARIA CANADENSIS ROOT, GOLDENSEAL, SILICON DIOXIDE, POTASSIUM CHLORIDE, PULSATILLA VULGARIS
Label structure11 sections

Indications and uses

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

Label contents#

Full prescribing information#

Active Ingedients

OTC - ACTIVE INGREDIENT SECTION

Hydrastis canadensis 6X

Kali muriaticum 3X

Pulsatilla 6X

Sanguinaria canadensis 6X

Silicea 6X

Inactive Ingredient

INACTIVE INGREDIENT SECTION

Cellulose

Lactose monohydrate

Magnesium stearate

Purpose

OTC - PURPOSE SECTION

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

Indications and Usage

INDICATIONS & USAGE SECTION

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

Dosage & Administration

DOSAGE & ADMINISTRATION SECTION

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

WARNINGS SECTION

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

Stop Use 

OTC - STOP USE SECTION

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Overdose

OVERDOSAGE SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Alpha SH_A01.jpgAlpha SH_A01.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9e37788c-b1bf-42ae-aac9-b60601606144Product name820260122
95250459-30e4-45c1-b08a-993044f49109Product name220250805
d9771140-739b-484b-ae64-b79528ff1211Product name320250801
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
1527ac37-808d-43be-a63e-74e1258dbe46Product name920250219
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
9fcb7a91-de07-4f00-aabf-e4d6fda403d5Product name820230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
0ec3537a-6c9b-432a-896c-b9ea8723049aProduct name920200701
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
7916de40-e296-41f0-b811-6d0df1a33e2cProduct name920180627
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53499-1391-1ALPHA SH10 in 1 BLISTER PACKTABLET1010
53499-1391-1ALPHA SH4 in 1 BOXTABLET410

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53499-1391ALPHA SH (SANGUINARIA CANADENSIS ROOT, GOLDENSEAL, SILICON DIOXIDE, POTASSIUM CHLORIDE, PULSATILLA VULGARIS ) TABLET [SCHWABE NORTH AMERICA, INC.]10Current NDC, Legacy NDC, 2 package rows20220323_94de9ce3-6ee9-4322-bda2-0b4391f09d87.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
GOLDENSEALACTIVE INGREDIENTZW3Z11D0JV3
POTASSIUM CHLORIDEACTIVE INGREDIENT660YQ98I103
PULSATILLA VULGARISACTIVE INGREDIENTI76KB35JEV3
SANGUINARIA CANADENSIS ROOTACTIVE INGREDIENTN9288CD5083
SILICON DIOXIDEACTIVE INGREDIENTETJ7Z6XBU43
GOLDENSEALACTIVE MOIETYZW3Z11D0JV3
POTASSIUM CATIONACTIVE MOIETY295O53K1523
PULSATILLA VULGARISACTIVE MOIETYI76KB35JEV3
SANGUINARIA CANADENSIS ROOTACTIVE MOIETYN9288CD5083
SILICON DIOXIDEACTIVE MOIETYETJ7Z6XBU43
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61U3
LACTOSEINACTIVE INGREDIENTJ2B2A4N98G3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I303

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53499-139153499-1391-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
SANGUINARIA CANADENSIS ROOTN9288CD508ACTIB
GOLDENSEALZW3Z11D0JVACTIB
SILICON DIOXIDEETJ7Z6XBU4ACTIB
POTASSIUM CHLORIDE660YQ98I10ACTIB
PULSATILLA VULGARISI76KB35JEVACTIB
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
MAGNESIUM STEARATE70097M6I30IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 6 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / SUBLINGUAL17.5 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GTABLET / SUBLINGUAL352 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / SUBLINGUAL17.5 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GTABLET / SUBLINGUAL352 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET / SUBLINGUAL43.2 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET / SUBLINGUAL43.2 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ALPHA SHSANGUINARIA CANADENSIS ROOT, GOLDENSEAL, SILICON DIOXIDE, POTASSIUM CHLORIDE, PULSATILLA VULGARISSchwabe North America, Inc.94de9ce3-6ee9-4322-bda2-0b4391f09d872022-03-22WarningsExact identifier
ndc (package): 53499-1391-1
ndc (product): 53499-1391
ndc11 (package): 53499139101
spl id: 99987865-e648-4746-ab77-ff24708d2a8e
spl set id: 94de9ce3-6ee9-4322-bda2-0b4391f09d87

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.