Label: ALLERGIEMITTEL- cardiospermum halicacabum flowering top, galphimia glauca flowering top, luffa operculata fruit tablet
- NDC Code(s): 68466-3590-4
- Packager: Schwabe Mexico S.A. de C.V.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
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.
Drug Label Information
Updated October 31, 2023
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- Official Label (Printer Friendly)
- Active Ingredient
- Inactive Ingredients
- Purpose
- Indications & Usage
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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 of age 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. - WarningsStop use
- Pregnancy or Breast Feeding
- Keep out of reach of children.
- Overdose
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ALLERGIEMITTEL
cardiospermum halicacabum flowering top, galphimia glauca flowering top, luffa operculata fruit tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68466-3590 Route of Administration SUBLINGUAL, SUBLINGUAL, SUBLINGUAL, 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:68466-3590-4 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 Mexico S.A. de C.V. (812805901) Establishment Name Address ID/FEI Business Operations Schwabe Mexico S.A. de C.V. 812805901 manufacture(68466-3590)
