Allergiemittel Tablets

Manufacturer
Schwabe North America, Inc. | Schwabe Mexico S.A. de C.V.
Effective date
2020-04-30
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 23:22:58

Label at a glance#

ProductAllergiemittel
Active ingredientCARDIOSPERMUM HALICACABUM FLOWERING TOP, GALPHIMIA GLAUCA FLOWERING TOP, LUFFA OPERCULATA FRUIT
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Boericke and Tafel Brand

ACTIVE INGREDIENTS:

Cardiospermum halicabum 3X

Galphimia glauca 3X

Luffa operculate 4X 

INACTIVE INGREDIENT SECTION


Inactive Ingredients:

Lactose monohydrate

Magnesium stearate

Microcrystalline cellulose

OTC - PURPOSE SECTION

OTC Purpose

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

INDICATIONS & USAGE SECTION

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 SECTION

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 SECTION

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

Pregnancy or Breast Feeding:

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

OVERDOSAGE SECTION

Overdosage:

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

OTC - ASK DOCTOR SECTION

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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53499-959053499-9590-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
9fbfba4a-99d0-4a0f-99ba-09aa05b2a135a54aacfb-3dc6-4c96-a82c-c1dcb6fa1ab12020-04-30WarningsExact identifier
spl id: 9fbfba4a-99d0-4a0f-99ba-09aa05b2a135
spl set id: a54aacfb-3dc6-4c96-a82c-c1dcb6fa1ab1

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.