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.

----------

Allergiemittel Tablets

Active Ingredients

Cardiospermum halicacabum 3X

Galphimia glauca 3X

Luffa operculate 5X 

Inactive Ingredients

Cellulose

Lactose Monohydrate

Magnesium Stearate

Purpose

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

Indications and Usage

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

Dosage & Administration

Directions:

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

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

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

Warnings
Stop use

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. 

Pregnancy or Breast Feeding

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

Keep out of reach of children.

Keep out of reach of children.

Overdosage

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

21812590_A01 Allergiemittel.jpg

Add image transcription here...

ALLERGIEMITTEL 
cardiospermum halicacabum flowering top, galphimia glauca flowering top, luffa operculata fruit tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53499-3590
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 FRUIT5 [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:53499-3590-14 in 1 CARTON04/28/2020
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic04/28/2020
Labeler - Schwabe North America, Inc. (831153908)
Establishment
NameAddressID/FEIBusiness Operations
Schwabe Mexico S.A. de C.V.812805901manufacture(53499-3590)

Revised: 10/2023
Document Id: 6d1cbd34-3766-4351-8567-db3113d6f168
Set id: 8aa3cd06-5a3a-4a16-9784-fbac3fc9c97b
Version: 5
Effective Time: 20231030
 
Schwabe North America, Inc.