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

Allergiemittel by

Drug Labeling and Warnings

Allergiemittel by is a Homeopathic medication manufactured, distributed, or labeled by Schwabe North America, Inc., Schwabe Mexico S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Cardiospermum halicacabum 3X

Galphimia glauca 3X

Luffa operculata 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 years of age:  Consult a doctor.

WarningsStop 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 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 Center immediately.

PRINCIPAL DISPLAY PANEL

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INGREDIENTS AND APPEARANCE

ALLERGIEMITTEL 
cardiospermum halicacabum flowering top, galphimia glauca flowering top, luffa operculata fruit tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53499-3590
Route of Administration	SUBLINGUAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CARDIOSPERMUM HALICACABUM FLOWERING TOP (UNII: MZP2508BRR) (CARDIOSPERMUM HALICACABUM FLOWERING TOP - UNII:MZP2508BRR)	CARDIOSPERMUM HALICACABUM FLOWERING TOP	3 [hp_X]
GALPHIMIA GLAUCA FLOWERING TOP (UNII: 93PH5Q8M7E) (GALPHIMIA GLAUCA FLOWERING TOP - UNII:93PH5Q8M7E)	GALPHIMIA GLAUCA FLOWERING TOP	3 [hp_X]
LUFFA OPERCULATA FRUIT (UNII: C4MO6809HU) (LUFFA OPERCULATA FRUIT - UNII:C4MO6809HU)	LUFFA OPERCULATA FRUIT	5 [hp_X]

Inactive Ingredients
Ingredient Name	Strength
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)

Product Characteristics
Color	white (BT)	Score	no score
Shape	ROUND (BT)	Size	10mm
Flavor		Imprint Code	B;T
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53499-3590-1	4 in 1 CARTON	04/28/2020
1		10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		04/28/2020

Labeler - Schwabe North America, Inc. (831153908)

Establishment
Name	Address	ID/FEI	Business Operations
Schwabe Mexico S.A. de C.V.		812805901	manufacture(53499-3590)