Otc - Active Ingredient
Boericke and Tafel Brand
ACTIVE INGREDIENTS:
Cardiospermum halicabum 3X
Galphimia glauca 3X
Luffa operculate 5X
Allergiemittel Tablet
FDA Label NDC 53499-3590
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Schwabe North America, Inc. for the product Allergiemittel (NDC 53499-3590). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, inactive ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Inactive Ingredient
Inactive Ingredients:
Lactose monohydrate
Magnesium stearate
Microcrystalline cellulose
Otc - Purpose
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
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
Otc - 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.
Otc - 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.
Package Label.Principal Display Panel
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