Alpha Sh

Sanguinaria Canadensis Root, Goldenseal, Silicon Dioxide, Potassium Chloride, Pulsatilla Vulgaris

Schwabe North America, Inc.
Human Otc Drug
NDC 53499-1391

Alpha Sh also known as Sanguinaria Canadensis Root, Goldenseal, Silicon Dioxide, Potassium Chloride, Pulsatilla Vulgaris is a human otc drug labeled by 'Schwabe North America, Inc.'. National Drug Code (NDC) number for Alpha Sh is 53499-1391. This drug is available in dosage form of Tablet. The names of the active, medicinal ingredients in Alpha Sh drug includes Goldenseal - 6 [hp_X]/1 Potassium Chloride - 3 [hp_X]/1 Pulsatilla Vulgaris - 6 [hp_X]/1 Sanguinaria Canadensis Root - 6 [hp_X]/1 Silicon Dioxide - 6 [hp_X]/1 . The currest status of Alpha Sh drug is Active.

Drug Information:

Drug NDC:	53499-1391
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name:	Alpha Sh
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type:	Human Otc Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name:	Sanguinaria Canadensis Root, Goldenseal, Silicon Dioxide, Potassium Chloride, Pulsatilla Vulgaris
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Schwabe North America, Inc.
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Tablet
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status:	Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:	GOLDENSEAL - 6 [hp_X]/1 POTASSIUM CHLORIDE - 3 [hp_X]/1 PULSATILLA VULGARIS - 6 [hp_X]/1 SANGUINARIA CANADENSIS ROOT - 6 [hp_X]/1 SILICON DIOXIDE - 6 [hp_X]/1
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:	SUBLINGUAL
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Marketing Category:	UNAPPROVED HOMEOPATHIC
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
Marketing Start Date:	18 Aug, 2011
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	31 Jan, 2027
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Listing Expiration Date:	10 May, 2026
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Manufacturer Name:	Schwabe North America, Inc.
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
Original Packager:	Yes
Whether or not the drug has been repackaged for distribution.
UPC:	0308078013909
UPC stands for Universal Product Code.
UNII:	ZW3Z11D0JV 660YQ98I10 I76KB35JEV N9288CD508 ETJ7Z6XBU4
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.
Pharmacologic Class:	Increased Large Intestinal Motility [PE] Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] Osmotic Activity [MoA] Osmotic Laxative [EPC] Potassium Compounds [CS] Potassium Salt [EPC]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDC	Description	Marketing Start Date	Marketing End Date	Sample Available
53499-1391-1	4 BLISTER PACK in 1 BOX (53499-1391-1) / 10 TABLET in 1 BLISTER PACK	18 Aug, 2011	31 Jan, 2027	No
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Other medicines with the same generic name

Alpha Sh

Sanguinaria Canadensis Root & more..

Tablet
Schwabe Mexico, S.A. de C.V.
NDC: 68466-4191

Alpha Sh

Sanguinaria Canadensis Root & more..

Tablet
Schwabe North America, Inc.
NDC: 53499-1391

Purpose:

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

Product Elements:

Alpha sh sanguinaria canadensis root, goldenseal, silicon dioxide, potassium chloride, pulsatilla vulgaris sanguinaria canadensis root sanguinaria canadensis root goldenseal goldenseal silicon dioxide silicon dioxide potassium chloride potassium cation pulsatilla vulgaris pulsatilla vulgaris lactose monohydrate magnesium stearate cellulose, microcrystalline b;t b;t b;t

Indications and 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).

Dosage and Administration:

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.

Stop Use:

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.

Overdosage:

Overdose in case of overdose, seek medical help or contact a poison control immediately.

Package Label Principal Display Panel:

Alpha sh_a01.jpg

Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.