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NDC 53499-1391-01 ALPHA SH 6; 3; 6; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 Details

ALPHA SH 6; 3; 6; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1

ALPHA SH is a SUBLINGUAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by Schwabe North America, Inc.. The primary component is GOLDENSEAL; POTASSIUM CHLORIDE; PULSATILLA VULGARIS; SANGUINARIA CANADENSIS ROOT; SILICON DIOXIDE.

Product Information

NDC	53499-1391
Product ID	53499-1391_99987865-e648-4746-ab77-ff24708d2a8e
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	ALPHA SH
Proprietary Name Suffix	n/a
Non-Proprietary Name	SANGUINARIA CANADENSIS ROOT, GOLDENSEAL, SILICON DIOXIDE, POTASSIUM CHLORIDE, PULSATILLA VULGARIS
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET
Route	SUBLINGUAL
Active Ingredient Strength	6; 3; 6; 6; 6
Active Ingredient Units	[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1
Substance Name	GOLDENSEAL; POTASSIUM CHLORIDE; PULSATILLA VULGARIS; SANGUINARIA CANADENSIS ROOT; SILICON DIOXIDE
Labeler Name	Schwabe North America, Inc.
Pharmaceutical 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]
DEA Schedule	n/a
Marketing Category	UNAPPROVED HOMEOPATHIC
Application Number	n/a
Listing Certified Through	n/a

Package

Package Images

NDC 53499-1391-01 (53499139101)

Pricing Information	N/A
NDC Package Code	53499-1391-1
Billing NDC	53499139101
Package	4 BLISTER PACK in 1 BOX (53499-1391-1) / 10 TABLET in 1 BLISTER PACK
Marketing Start Date	2011-08-18
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 94de9ce3-6ee9-4322-bda2-0b4391f09d87 Details

Active Ingedients

Hydrastis canadensis 6X

Kali muriaticum 3X

Pulsatilla 6X

Sanguinaria canadensis 6X

Silicea 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.

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.

PRINCIPAL DISPLAY PANEL

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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]

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:53499-1391-1	4 in 1 BOX	08/18/2011	01/31/2027
1		10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		08/18/2011	01/31/2027

Labeler - Schwabe North America, Inc. (831153908)

Name	Address	ID/FEI	Business Operations
Establishment
Schwabe Mexico, S.A. de C.V.		812805901	manufacture(53499-1391)

Revised: 3/2022

Document Id: 99987865-e648-4746-ab77-ff24708d2a8e

Set id: 94de9ce3-6ee9-4322-bda2-0b4391f09d87

Version: 10

Effective Time: 20220322