ALPHA SH- sanguinaria canadensis root, goldenseal, silicon dioxide, potassium chloride, pulsatilla vulgaris tablet

ALPHA SH by

Drug Labeling and Warnings

ALPHA SH by is a Homeopathic medication manufactured, distributed, or labeled by Schwabe North America, Inc., Schwabe Mexico, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Inactive Ingredients

Microcrystalline cellulose

lactose monohydrate

magnesium sterate

INACTIVE INGREDIENT

INACTIVE INGREDIENT:

Lactose monohydrate

Magnesium stearate

Microcrystalline cellulose

PURPOSE

PURPOSE:

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

KEEP OUT OF REACH OF CHILDREN

Keep out of the reach of children.

INDICATIONS & USAGE

INDICATIONS AND USAGE:

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

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.

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.

PREGNANCY OR BREAST FEEDING

Pregnancy or Breast Feeding:

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

OVERDOSAGE

Overdosage:

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

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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANELBoericke and Tafel Alpha SH 21801390 40 tablets

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)