Otc - Active Ingredient
Active ingredients** (in each tablet)
Arnica montana 30X HPUS (2.5 mg)
The letters HPUS indicate that the component in this product is officially monographed in the Homeopathic Pharmacopoeia of the United States.
Arnica Tablet
FDA Label NDC 0220-9089
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Boiron for the product Arnica (NDC 0220-9089). 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, otc - purpose, indications & usage, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose*
Relieves muscle pain & stiffness, swelling from injuries, discoloration from bruises
Indications & Usage
Uses*
temporarily relieves muscle pain and stiffness due to: minor injuries overexertion falls
reduces symptoms of bruising such as: pain swelling discoloration
Otc - Stop Use
Stop use and ask a doctor if symptoms persist for more than 7 days or worsen, new symptoms occur, or if redness or swelling is present. These could be signs of a serious condition.
Otc - 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. In case of overdose, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Adults and children 6 years for 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 5 years of age: Dissolve 2 tablets in 1 tablespoon of water for easier intake. Follow directions above.
Children under 2 years of age: Ask a doctor.
Inactive Ingredient
croscarmellose sodium, lactose, magnesium stearate
Otc - Questions
Questions or comments?
Arnicare.com
BoironUSA.com
1-800-BOIRON-1
(1-800-264-7661)
Made in France
Distributed by Boiron Inc.
Newtown Square, PA 19073
Other
do not use if glued carton ends flaps are open or if the blister seal is broken
store below 86°F (30°C)
PAIN RELIEF*
Swelling & Bruises from Injuries Muscle Pain*
60 Meltaway Tablets, unflavored
Gentle on the stomach
NSAID-Free
No Known Drug Interactions
Non-Drowsy
Meltaway Tablets Require No Food or Water
*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.
**C,K,CK, and X are homeopathic dilutions: see BoironUSA.com/info for details.
* Please review the disclaimer below.
