ALPHA SH

Manufacturer
Schwabe Mexico, S.A. de C.V.
Effective date
2020-10-16
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-01 23:11:08

Label at a glance#

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

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

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

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENT:

Lactose monohydrate

Magnesium stearate

Microcrystalline cellulose

OTC - PURPOSE SECTION

PURPOSE:

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

INDICATIONS & USAGE SECTION

INDICATIONS AND USAGE:

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

WARNINGS SECTION

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 SECTION

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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

Pregnancy or Breast Feeding:

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

OVERDOSAGE SECTION

Overdosage:

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

OTC - ASK DOCTOR SECTION

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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Alpha SH_A01.jpgAlpha SH_A01.jpg

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
68466-319168466-3191-1

Ingredients#

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

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

Source Document#

Source XML

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
934044a8-8f62-47bf-bbf7-2bf80cc31bb46fe08691-e98a-45e7-b49f-17007e2eb0c72020-10-16WarningsExact identifier
spl id: 934044a8-8f62-47bf-bbf7-2bf80cc31bb4
spl set id: 6fe08691-e98a-45e7-b49f-17007e2eb0c7

Reported adverse events (FAERS/openFDA)#

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