ALPHA SH: Homeopathic Product Information

ALPHA SH- sanguinaria canadensis root, goldenseal, silicon dioxide, potassium chloride and pulsatilla vulgaris tablet
Schwabe North America, Inc.

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.

Active Ingedients

Hydrastis canadensis 6X,

Kali muriaticum 3X,

Pulsatilla 6X,

Sanguinaria canadensis 6X,

Sileca 6X

Inactive Ingredient

Cellulose

Lactose monohydrate

Magnesium stearate

Purpose

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

ALPHA SH Indications and Usage

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

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

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

Stop Use

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

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

Keep out of reach of children

Keep out of reach of children.

Overdose

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

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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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SANGUINARIA CANADENSIS ROOT (SANGUINARIA CANADENSIS ROOT) SANGUINARIA CANADENSIS ROOT 6 [hp_X]
GOLDENSEAL (GOLDENSEAL) GOLDENSEAL 6 [hp_X]
SILICON DIOXIDE (SILICON DIOXIDE) SILICON DIOXIDE 6 [hp_X]
POTASSIUM CHLORIDE (POTASSIUM CATION) POTASSIUM CHLORIDE 3 [hp_X]
PULSATILLA VULGARIS (PULSATILLA VULGARIS) PULSATILLA VULGARIS 6 [hp_X]
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
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 Multilevel Packaging
1 NDC:53499-1391-1 4 BLISTER PACK in 1 BOX contains a BLISTER PACK
1 10 TABLET in 1 BLISTER PACK This package is contained within the BOX (53499-1391-1)
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 Operations
Schwabe Mexico, S.A. de C.V. 812805901 manufacture (53499-1391)

Revised: 10/2020 Schwabe North America, Inc.

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