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  5. Label Information: Allergiemittel

FDA Label for Allergiemittel

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. INACTIVE INGREDIENT
    3. OTC - PURPOSE
    4. OTC - KEEP OUT OF REACH OF CHILDREN
    5. INDICATIONS & USAGE
    6. WARNINGS
    7. DOSAGE & ADMINISTRATION
    8. OTC - PREGNANCY OR BREAST FEEDING
    9. OVERDOSAGE
    10. OTC - ASK DOCTOR
    11. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Allergiemittel Product Label

The following document was submitted to the FDA by the labeler of this product Schwabe North America, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Active Ingredient



Boericke and Tafel Brand

ACTIVE INGREDIENTS:

Cardiospermum halicabum 3X

Galphimia glauca 3X

Luffa operculate 5X 


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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