FDA Label for Arnica
View Indications, Usage & Precautions
Arnica Product Label
The following document was submitted to the FDA by the labeler of this product Laboratoires Boiron. 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** (in each pellet)
Arnica montana 30C HPUS (0.443 mg)
The letters "HPUS" indicate that the component in this product is officially monographed in Homeopathic Pharmacopoeia of the United States.
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
- pain
- swelling
- discoloration
reduces symptoms of bruising such as:
Warnings
Otc - Stop Use
Stop use and ask a doctor if symptoms persist for more than 3 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 breastfeeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Directions Adults and children: At the onset of symptoms, dissolve 5 pellets under the tongue 3 times a day until symptoms are relieved or as directed by a doctor.
Inactive Ingredient
lactose, sucrose.
Other
Pain Relief"
Muscle Pain & Stiffness, Swelling from Injuries, Bruises*
Do not use if glued carton end flaps are open or if the pellet dispenser seal is broken.
No Known Drug Interactions
Plant-Powered Relief
No Artificial Colors, Flavors, Sweeteners, or Preservatives
How to dispense pellets? Turn tube upside down Twist until 5 pellets are dispensed Remove the cap and pour pellets under the tongue.
16 Doses per Tube
3 Tubes approx. 80 quick dissolving pellets per tube
Total 240 Pellets
*Claims are 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.
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 19073-3267
* Please review the disclaimer below.