Otc - Active Ingredient
Active ingredient** (in each tablet)
Arnica montana 9C HPUS (2.5 mg)
The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.
Arnicare Bruise Tablet
FDA Label NDC 0220-9083
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 Arnicare Bruise (NDC 0220-9083). 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 - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose*
Arnica montana 9C HPUS (2.5 mg) ... Relieves discoloration, pain, and swelling associated with bruising
Indications & Usage
Uses*
reduces symptoms of bruising such as: discoloration, pain, swelling
Otc - Ask Doctor
Ask a doctor before use if
- bruising limits the range of motion of your eyes, limbs, head
- pain is severe
- bruising is frequent.
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 breastfeeding, ask a health profession 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
Directions
Adults and children 6 years of age and older - As soon as bruising occurs, 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 bruising has faded.
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.
Other
- do not use if glued carton end flaps are open or if the blister seal is broken
- store below 86° F (30° C)
60 meltaway tablets
Bruise relief*
Discoloration, Pain, Swelling*
No Known Drug Interactions
Non-Drowsy
Gentle on the stomach
Convenient & Painless
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.
Inactive Ingredient
croscarmellose sodium, lactose, magnesium stearate
Otc - Questions
Arnicare.com
BoironUSA.com
1-800-BOIRON-1
(1-800-264-7661)
Made in France
Distributed by Boiron Inc.
Newtown Square, PA 19073
* Please review the disclaimer below.
