Otc - Active Ingredient
Active Ingredient:
Arnica Montana 30C
Arnica Montana Tablet
FDA Label NDC 53499-3571
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 Arnica Montana (NDC 53499-3571). 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, dosage & administration, indications & usage, otc - purpose, warnings, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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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