Otc - Active Ingredient
Active ingredient** (in each pellet)
Arnica montana 30X HPUS (0.443 mg)
The letter "HPUS" indicate that the component in this product is officially monographed in the Homeopathic Pharmacopoeia of the United States.
Arnica Montana 30x Bonus Pack Pellet
FDA Label NDC 0220-9053
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 Montana 30x Bonus Pack (NDC 0220-9053). 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 - ask doctor, 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 and 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:
Otc - Ask Doctor
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
Do not use if glued carton end flaps are open or if pellet dispenser seal is broken.
How to dispense pellets? Turn tube upside down. Twist until 5 pellets are dispensed Remove cap and pour pellets under the tongue
3 Tubes
Approx. 80 pellets each
Total 240 pellets
16 Doses per tube
Pain relief*
Muscle Pain & Stiffness Swelling from injuries Bruises*
No Know Drug Interactions
Plant-Powered Relief
*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.
Otc - Questions
Arnicare.com
BoironUSA.com
1-800-BOIRON-1 (1-800-264-7661)
Distributed by Boiron, Inc.
Newtown Square, PA 19073
Made in France
* Please review the disclaimer below.
