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  5. Label Information: Arnica Montana

FDA Label for Arnica Montana

View Indications, Usage & Precautions

Table of Contents

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

Arnica Montana 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



Active Ingredient:

Arnica Montana 30C


Inactive Ingredient



Inactive Ingredients:

CELLULOSE

CROSCARMELLOSE SODIUM

LACTOSE MONOHYDRATE

MAGNESIUM STEARATE


Dosage & Administration



Dosage and Administration:

Boericke and Tafel Brand

Directions: Adults or children over 2 years:  Take 3 tablets 1-3 times a day.

Allow to dissolve under tongue. 


Indications & Usage



Indications and Usage: 

Temporarily relieves minor muscle or joint aches and pans from strains, sprains, bruises, bachache, over extertion.


Otc - Purpose



Purpose:

For the temporary relief of minor muscle or joint aches and pains from strains, sprains, bruises, bachacke and over exertion.


Warnings



Warnings:

Do not use this product for pain for more than 10 days (adult) or 5 days (children) unless directed by a doctor. 

When using this product, if pain persists or gets worse, if new symptoms occur, or if redness or swelling is present, consult a doctor because these could be signs of a serious condition.


Otc - Pregnancy Or Breast Feeding



Pregnancy or Breast Feeding:

If pregnant or breast-feeding, ask a health professional before use.


Otc - Keep Out Of Reach Of Children



Keep Out of Reach of Children:

Keep out of reach of children.


Otc - Ask Doctor




Ask the Doctor:

Do not take product for pain for more than 10 days (adult) or 5 days (children) unless directed by a doctor. 

If pain persists or gets worse, if new symptoms occur, or if redness or swelling is present, consult a doctor because these could be signs of a serious condition.


Overdosage



Overdosage:

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


Package Label.Principal Display Panel



Borieck and Tafel Brand
Arnica Montana 30C 250 tabs

21203574_Arnica montana-30C_05


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