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 INGREDIENT

Boericke and Tafel Brand

ACTIVE INGREDIENTS:

Cardiospermum halicabum 3X

Galphimia glauca 3X

Luffa operculate 4X 

INACTIVE INGREDIENT

Inactive Ingredients:

Lactose monohydrate

Magnesium stearate

Microcrystalline cellulose

PURPOSE

OTC Purpose

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

INDICATIONS & USAGE

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

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 & ADMINISTRATION

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

Pregnancy or Breast Feeding:

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

OVERDOSAGE

Overdosage:

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

ASK DOCTOR

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.

PRINCIPAL DISPLAY PANEL

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: 53499-9590
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	4 [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: 53499-9590-1	4 in 1 CARTON	04/01/2017
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		04/01/2017

Labeler - Schwabe North America, Inc. (831153908)

Establishment
Name	Address	ID/FEI	Business Operations
Schwabe Mexico S.A. de C.V.		812805901	manufacture(53499-9590)