Allergiemittel: Homeopathic Product Information

ALLERGIEMITTEL- cardiospermum halicacabum flowering top, galphimia glauca flowering top and luffa operculata fruit tablet
Schwabe Mexico S.A. de C.V.

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.

Active Ingredient

Cardiospermum halicabum 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 & 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 per day until relieved.
Children 6 to 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.

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.

Overdose

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

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

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68466-3590 Route of Administration SUBLINGUAL, SUBLINGUAL, SUBLINGUAL, SUBLINGUAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CARDIOSPERMUM HALICACABUM FLOWERING TOP (CARDIOSPERMUM HALICACABUM FLOWERING TOP) CARDIOSPERMUM HALICACABUM FLOWERING TOP 3 [hp_X] GALPHIMIA GLAUCA FLOWERING TOP (GALPHIMIA GLAUCA FLOWERING TOP) GALPHIMIA GLAUCA FLOWERING TOP 3 [hp_X] LUFFA OPERCULATA FRUIT (LUFFA OPERCULATA FRUIT) LUFFA OPERCULATA FRUIT 5 [hp_X]

Inactive Ingredients Ingredient Name Strength LACTOSE MONOHYDRATE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE

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

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:68466-3590-4 4 BLISTER PACK in 1 CARTON contains a BLISTER PACK 1 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (68466-3590-4)

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

Labeler — Schwabe Mexico S.A. de C.V. (812805901)

Establishment
Name	Address	ID/FEI	Operations
Schwabe Mexico S.A. de C.V.		812805901	manufacture (68466-3590)

Revised: 10/2022 Schwabe Mexico S.A. de C.V.