ALPHA SH - sanguinaria canadensis root, goldenseal, silicon dioxide, potassium chloride and pulsatilla vulgaris tablet 
Nature's Way Products, 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.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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ACTIVE INGREDIENTS HPUS:

Sanguinaria canadensis 6X

Hydrastis canadensis 6X

Silicea 6X

Kali muriaticum 3X

Pulsatilla 3X


INACTIVE INGREDIENT:

Lactose

Magnesium stearate

Microcrystalline cellulose

PURPOSE:

Temporarily relieves the minor pain of sinus headache.  Shrinks swollen nasal membranes, helps decongest sinus openings and sinus passages, promotes sinus drainage.

Keep out of the reach of children


INDICATIONS AND USAGE:

Temporarily relieves the minor pain of sinus headache.  Shrinks swollen nasal membranes, helps decongest sinus openings and sinus passages, promotes sinus drainage.

Directions:

Sublingual medication. Place tablets under tongue at least 15 minutes before or half hour after eating, brushing teeth, or drinking anything except water.

WARNINGS:

Do not take this product for headache pain for more than 10 days (for adults) or 5 days (for children).  If symptoms persist, get worse, or are accompanied by a high fever, or if new symptoms occur, consult a doctor because these can be signs of a serious condition.  As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product.

DOSAGE:

Adults and children 12 years of age and older: 2 tablets every two hours until relieved.

Children 2 to 12: Half of the adult dose.

Children under 2: Consult a doctor.

Alpha SH Sinus Headache 21801390 Carton

Alpha SH Sinus Headache 21801390 Carton



ALPHA SH 
sanguinaria canadensis root, goldenseal, silicon dioxide, potassium chloride, pulsatilla vulgaris tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53499-1390
Route of AdministrationSUBLINGUALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SANGUINARIA CANADENSIS ROOT (SANGUINARIA CANADENSIS ROOT) SANGUINARIA CANADENSIS ROOT6 [hp_X]
GOLDENSEAL (GOLDENSEAL) GOLDENSEAL6 [hp_X]
SILICON DIOXIDE (SILICON DIOXIDE) SILICON DIOXIDE6 [hp_X]
POTASSIUM CHLORIDE (POTASSIUM CATION) POTASSIUM CHLORIDE3 [hp_X]
PULSATILLA VULGARIS (PULSATILLA VULGARIS) PULSATILLA VULGARIS3 [hp_X]
Inactive Ingredients
Ingredient NameStrength
LACTOSE 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
Product Characteristics
Colorwhite (B;T) Scoreno score
ShapeROUND (B;T) Size8mm
FlavorImprint Code B;T
Contains    
Packaging
#Item CodePackage Description
1NDC:53499-1390-14 in 1 BOX
110 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic08/18/2011
Labeler - Nature's Way Products, Inc. (153970520)
Establishment
NameAddressID/FEIBusiness Operations
Schwabe Mexico SA DE CV824412357manufacture

Revised: 08/2011
Document Id: 8a98401d-0afd-4895-83e4-37496ba91574
Set id: 94de9ce3-6ee9-4322-bda2-0b4391f09d87
Version: 2
Effective Time: 20110818
 
Nature's Way Products, Inc.