ALLERGIEMITTEL- cardiospermum halicacabum flowering top, galphimia glauca flowering top, luffa operculata fruit  tablet 
Schwabe North America, 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.

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Allergiemittel Tablets

Boericke and Tafel Brand

ACTIVE INGREDIENTS:

Cardiospermum halicabum 3X

Galphimia glauca 3X

Luffa operculate 4X 


Inactive Ingredients:

Lactose monohydrate

Magnesium stearate

Microcrystalline cellulose

OTC Purpose

Temporarily relieves minor allergic symptoms:  sneezing, runny, stuffy, itchy nose, red, itchy, watery eyes, scratchy throat.

Keep out of reach of children.

Indications and Usage:

For temporary relief of minor allergic symptoms such as sneezing; runny, stuffy, itchy nose; red, watery, or itching eyes; scratchy throat.

WARNINGS:

Stop use and ask a doctor if symptoms worsen, do not improve, are accompanied by a fever, or if new symptoms occur..

In the event of severe allergic reactions, consult a doctor immediately.

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 after eating, brushing teeth, or drinking anything except water.

Adults and Children 12 Years and older: Take 1 tablet every hour until symptoms subside, then 1 tablet 3 times per day until relieved.
Children 6 to 12:  Take 1/2 tablet every hour until symptoms subside, then 1/2 tablet 2 times a day until relieved.
Children under 2:  Consult a doctor.

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

Pregnancy or Breast Feeding:

If pregnany or breastfeeding, ask a healthcare professional before use.

Overdosage:

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

Ask the Doctor:

Stop use and ask a doctor if symptoms worsen, do not improve, are accompanied by a fever, or if new symptoms occur.
In the event of severe allergic reactions, consult a doctor immediately.

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ALLERGIEMITTEL 
cardiospermum halicacabum flowering top, galphimia glauca flowering top, luffa operculata fruit tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53499-9590
Route of AdministrationSUBLINGUAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CARDIOSPERMUM HALICACABUM FLOWERING TOP (UNII: MZP2508BRR) (CARDIOSPERMUM HALICACABUM FLOWERING TOP - UNII:MZP2508BRR) CARDIOSPERMUM HALICACABUM FLOWERING TOP3 [hp_X]
GALPHIMIA GLAUCA FLOWERING TOP (UNII: 93PH5Q8M7E) (GALPHIMIA GLAUCA FLOWERING TOP - UNII:93PH5Q8M7E) GALPHIMIA GLAUCA FLOWERING TOP3 [hp_X]
LUFFA OPERCULATA FRUIT (UNII: C4MO6809HU) (LUFFA OPERCULATA FRUIT - UNII:C4MO6809HU) LUFFA OPERCULATA FRUIT4 [hp_X]
Inactive Ingredients
Ingredient NameStrength
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
Product Characteristics
Colorwhite (BT) Scoreno score
ShapeROUND (BT) Size10mm
FlavorImprint Code B;T
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53499-9590-14 in 1 CARTON04/01/201701/30/2025
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic04/01/201701/30/2025
Labeler - Schwabe North America, Inc. (831153908)
Establishment
NameAddressID/FEIBusiness Operations
Schwabe Mexico S.A. de C.V.812805901manufacture(53499-9590)

Revised: 4/2020
Document Id: 9fbfba4a-99d0-4a0f-99ba-09aa05b2a135
Set id: a54aacfb-3dc6-4c96-a82c-c1dcb6fa1ab1
Version: 4
Effective Time: 20200430
 
Schwabe North America, Inc.