Otc - Active Ingredient
Arnica Montana 9C
Arnicare Arnica Tablet
FDA Label NDC 0220-9059
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Laboratoires Boiron for the product Arnicare Arnica (NDC 0220-9059). 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, indications & usage, inactive ingredient, how supplied, otc - purpose, storage and handling, otc - questions, otc - ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Indications & Usage
Temporary relieves muscle pain and stiffness due to minor injuries, overexertion and falls.
Reduces pain, swelling and discoloration from bruises.
Inactive Ingredient
Croscarmellose sodium, lactose, magnesium, stearate.
How Supplied
60 tablets
Otc - Purpose
Arnica Montana 9C Trauma, muscle pain and stiffness, swelling from injuries, discoloration from bruising.
Storage And Handling
Store at 68-77 o F (20-25 o C)
Otc - Questions
Questions, Comments
www.boironusa.com
[email protected] 1-800-BOIRON-1
(1-800-264-7661)
Boiron Information Center
6 campus Bouelvard
Newtown Square, PA
19073-3267
Otc - Ask Doctor
Otc - Stop Use
Stop use and ask a doctor if symptoms persist continuously for more than 7 days or worsen, if new symptoms occur, or if redness or swelling is present because these could be signs of a serious illness.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children
Otc - When Using
Drug Interactions
Non drowsy, no side effects, no drug interactions, works naturally with your body
Warnings
Do not use if glued carton end flaps or if the blister seal is broken.
Dosage & Administration
Adults and children 6 years of age and older: At the onset of symptoms dissolve 2 tablets in the mouth and repeat every hour for 2 more hours. Then, dissolve 2 tablets in the mouth every 6 hours until symptoms are relieved.
Children 2 to 6 years of age: Dissolve 2 tablets in 1 tablespoon of water for easier intake. Follow directions above.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before us.
* Please review the disclaimer below.
