Leg Cramps Tablet, Soluble
FDA Label NDC 54973-2956
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 Consumer Health Inc. for the product Leg Cramps (NDC 54973-2956). 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 drug facts, active ingredients, otc - purpose, uses, warnings, other, otc - keep out of reach of children, otc - do not use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients
Active ingredients | Purpose |
Aconitum Napellus 6X HPUS | pains in joints and legs |
Cinchona Officinalis 3X HPUS | pains in limbs and joints; cramping in legs |
Gnaphalium Polycephalum 3X HPUS | cramps in calves and feet |
Ledum Palustre 6X HPUS | pain and cramps in legs |
Magnesia Phosphorica 6X HPUS | muscle cramps |
Rhus Toxicodendron 6X HPUS | pain and stiffness |
Viscum Album 3X HPUS | pains in joints |
“HPUS” indicates that the active ingredients are in the official Homeopathic Pharmacopoeia of the United States.
Otc - Purpose
Relax Calf & Foot Cramps
Uses
Uses Temporarily relieves the symptoms of: • stiffness • pains in limbs, joints or legs • cramps in calves • feet or legs
Warnings
As with any drug, ask a doctor before use if pregnant or breast-feeding.
Other
Consult a physician if: • symptoms persist for more than 7 days or worsen.
• sensitive to quinine.
*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED. |
Otc - Keep Out Of Reach Of Children
Keep this and all medications out of the reach of children.
Otc - Do Not Use
In case of emergency or accidental overdose, contact a medical professional or
Poison Control Center immediately. Hyland's may also be contacted for emergency
information about our products 24 hours a day, 7 days per week at (800) 624-9659.
Directions
Adults and children 12 years and over | Dissolve 2–3 tablets under tongue every 4 hours. If the initial dosage is not providing relief, dissolve 2–3 tablets under tongue every 15 minutes, up to 6 doses. |
Under 12 years of age | Consult a physician. |
Other Information
- Do not use if imprinted "SEALED FOR YOUR PROTECTION" tamper-evident
bottle cap band is broken or missing.
Inactive Ingredients
Acacia Gum, Lactose.
Otc - Questions
(800) 624-9659
Indications And Usage Dosage And Administration
Uses
- Temporarily relieves the symptoms of:
- stiffness
- pain in limbs, joints or legs
- cramps in calves, feet or legs
Directions
Adults and children 12 years and over | Dissolve 2–3 tablets under tongue every 4 hours. If the initial dosage is not providing relief, dissolve 2–3 tablets under tongue every 15 minutes, up to 6 doses. |
Under 12 years of age | Consult a physician. |
Principal Display Panel - 100 Tablet Bottle Carton
HOMEOPATHIC
NDC 54973-2956-6
NATURAL
RELIEF
SINCE 1903
Hyland's
Leg
Cramps
Relax Calf &
Foot Cramps*
BOSTON ATHLETIC ASSOCIATION
BOSTON MARATHON
OFFICIAL
SPONSOR
100 QUICK-DISSOLVING TABLETS
*SEE NOTE ON BACK PANEL
BELOW DRUG FACTS
* Please review the disclaimer below.
