Otc - Active Ingredient
Active Ingredient: Arnica Montana HPUS 30c
Arnica Montana
FDA Label NDC 42681-0508
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Whole Foods Market for the product Arnica Montana (NDC 42681-0508). 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, dosage & administration, uses, warnings, otc - pregnancy or breast feeding, otc - keep out of reach of children, other safety information, otc - do not use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Dosage & Administration
Directions: (adults and children 12 years and older) Dissolve 5 pellets under the tongue 3 times per day until symptoms are relieved or as directed by a doctor.
Uses
For the conditions listed under purposes or as directed by a doctor.
Warnings
Warnings: Stop use and ask a doctor if symptoms persist for more than 3 days or worsen.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health care professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Other Safety Information
Store at room temperature.
Otc - Do Not Use
other information: Do not use if pellet dispenser seal is broken.
Inactive Ingredient
Inactive Ingredients: Lactose, sucrose.
Otc - Purpose
Purposes: relief of muscle aches and soreness, swelling, stiffness and bruising.
Package Label.Principal Display Panel
365_arnicapellettube-1052011 (365 Arnicapellettube 1052011)
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