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Drug Facts
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Arnica Tablet, Soluble
FDA Label NDC 54973-3084
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Hyland's Inc. for the product Arnica (NDC 54973-3084). 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 other, active ingredients, purpose, uses, otc - ask doctor, otc - keep out of reach of children, otc - do not use, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients
Arnica Montana 30X HPUS
"HPUS" indicates that the active ingredients are in the official Homeopathic Pharmacopœia of the United States.
Purpose
bruising, swelling, stiffness, muscle soreness and pain
Uses
Temporarily relieves bruising, swelling, stiffness,pain and muscle soreness due to injuries or overexertion.
Otc - Ask Doctor
As with any drug, ask a doctor before use if pregnant or breast-feeding. Consult a physician if symptoms persist for more than 7 days or worsen.
Otc - Keep Out Of Reach Of Children
Keep this and all medications out of the reach of children. In case of accidental overdose, contact a medical professional or poison control center immediately.
Otc - Do Not Use
Do not use if imprinted tamper band is broken or missing.
Directions
| Adults and children 12 years and over | dissolve 1-2 tablets under tongue 4 times per day; 1-2 tablets may be taken in anticipation of strenuous activity or injury |
| Children ages 6-12 years | dissolve 1 tablet under tongue 4 times per day; 1 tablet may be taken in anticipation of strenuous activity or injury. |
Inactive Ingredients
Acacia Gum, Lactose
Principal Display Panel - 50 Tablet Bottle Carton
NDC 54973-3084-1
HOMEOPATHIC
Natural
Relief
SINCE 1903
Hyland's®
Arnica 30X
PAIN RELIEF FORMULA*
Safe and Effective Relief of:
- Bruising and Swelling
- Back, Shoulder and Neck Pain
- Muscle Soreness
50 Quick-Dissolving Tablets
ACTUAL SIZE 194 MG
* Please review the disclaimer below.
