ALLERGIEMITTEL - cardiospermum halicacabum flowering top, galphimia glauca flowering top and luffa operculata fruit 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:

Cardiospermum 3X

Galphimia glauca 3X

Luffa Operculate 4X


Inactive Ingredients:

Lactose,

Magneisum Stearate

Microcrystalline cellulose

OTC Purpose

For temporary relief of minor allergic symptoms such as sneezing, runny, stuffy, itchy, or tickling nose, red, watery, or itching eyes; scratchy throat; wheezing, or shortness of breath cause by allergies.


Keep out of reach of children



Indications and Usage

For temporary relief of minor allergic symptoms such as sneezing, runny, stuffy, itchy, or tickling nose, red, watery, or itching eyes; scratchy throat; wheezing, or shortness of breath cause by allergies.

WARNINGS:

If symptoms worsen, do not improve, are accompanied by a fever, or if new symptoms occur, consult a doctor.  In the event of severe allergic reactions, consult a doctor immediately.  As with any drug, if you are pregnant or nursing a baby, seek the advise of a health professional before using this product.

Dosage and Administration:

Sublingual medication:  Place under tongue and let dissolve.  Take before exposure to allergen or as soon after symptoms appear as possible, at least 15 minutes before or half an hour fer eating, brushing teeth, or drinking anything except water.

ADULTS and CHILDREN 12 Years and older:  1 tablet every hour until symptoms subside, then 1 tablet 3 times per day until relieved.
CHILDREN 2 TO 12:  Half of the adult dose
CHILDREN UNDER 2:  Consult a doctor

Preventative use:  Take 4-6 weeks before allergy season starts;  1 tablet 3 times per day



Alergiemittel 21812590 Carton

Alergiemittel 21812590 Carton

ALLERGIEMITTEL 
cardiospermum halicacabum flowering top, galphimia glauca flowering top, luffa operculata fruit tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53499-2590
Route of AdministrationSUBLINGUALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CARDIOSPERMUM HALICACABUM FLOWERING TOP (CARDIOSPERMUM HALICACABUM FLOWERING TOP) CARDIOSPERMUM HALICACABUM FLOWERING TOP3 [hp_X]
GALPHIMIA GLAUCA FLOWERING TOP (GALPHIMIA GLAUCA FLOWERING TOP) GALPHIMIA GLAUCA FLOWERING TOP3 [hp_X]
LUFFA OPERCULATA FRUIT (LUFFA OPERCULATA FRUIT) LUFFA OPERCULATA FRUIT4 [hp_X]
Inactive Ingredients
Ingredient NameStrength
LACTOSE 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
Product Characteristics
Colorwhite (BT) Scoreno score
ShapeROUND (BT) Size10mm
FlavorImprint Code B;T
Contains    
Packaging
#Item CodePackage Description
1NDC:53499-2590-14 in 1 CARTON
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
 
Nature's Way Products, Inc.