Homeopathic Claims
*CLAIMS BASED ON TRADITIONAL HOMEOPATHICPRACTICE,
NOT ACCEPTED MEDICAL EVIDENCE, NOT FDA EVALUATED.
Hylands Leg Cramps With Arnica Tablet
FDA Label NDC 54973-4126
12 label sections · Submitted to the FDA by Hyland's Consumer Health Inc. · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Hyland's Consumer Health Inc. for the product Hylands Leg Cramps With Arnica (NDC 54973-4126). 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 homeopathic claims, drug facts, active ingredients, purpose*, uses*, directions, inactive ingredients, questions?, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Drug Facts
Drug Facts
Active Ingredients
ACONITUM NAPELLUS 5X HPUS
ARNICA MONTANA 5X HPUS
CINCHONA OFFICINALIS 2X HPUS
GNAPHALIUM POLYCEPHALIUM 2X HPUS
LEDUM PAULSTRE 5X HPUS
MAGNESIA PHOSPHORICA 5X HPUS
RHUS TOXICODENDRON 5X HPUS
"HPUS" is the Homeopathic Pharmacopeia of the United States
Purpose*
Pain in joints and legs
Leg muscle soreness and pain
Cramping in legs
Cramps in calves and feet
Pain and cramps in legs
Muscle cramps
Pain and stiffness
Uses*
Helps temporarily relieve symptoms of:
- Stiffness
- Pain in joints or legs
- Cramps in calves, feet or legs
- Residuall muscle soreness
Directions
Use as directed
Adults and children 12 and over:
At onset of symptoms, swallow 1-2 caplets with water every 4 hours as needed. If the initial dosage is not providing immediate relief, swallow 1-2 caplets with water every 30 minutes until relieved, up to 6 doses.
Children under 12 years of age:
Ask a doctor beofre use
Inactive Ingredients
Lactose, Magnesium Stearate, Microcrystalline Cellulose
Questions?
www.hylands.com or [email protected]
Dosage & Administration
Oral
Otc - Keep Out Of Reach Of Children
KEEP OUT OF REACH OF CHILDREN
Warnings
ASK A DOCTOR BEFORE USE IF:
SENSITIVE TO QUININE
PREGNANT OR BREASTFEEDING
Package Label.Principal Display Panel
Hylands Naturals
Leg Cramps*
+Arnica
Helps relieve leg
cramps and residual soreness
100
caplets
[product image]
Homeopathic
* Please review the disclaimer below.
