Otc - Purpose
Temporarily relieves the symptoms of stiffness, pains in limbs, joints, legs and cramps in calves, feet and legs.
Leg Cramps Tablet, Soluble
FDA Label NDC 54973-3114
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 Leg Cramps (NDC 54973-3114). 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 - purpose, drug facts, active ingredients, otc - pregnancy or breast feeding, otc - ask doctor, otc - keep out of reach of children, other, uses, 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
| 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 | Muscle cramps |
| Ledum Palustre 6X HPUS | pain and cramps in legs |
| Magnesia Phosphorica 6X HPUS | cramps in calves |
| Rhus Toxicodendron 6X HPUS | pain and stiffness |
| Viscum Album 3X HPUS | pains in joints |
"HPUS" indicates the active ingredients are in the official Homeopathic Pharmacopœia of the United States.
Otc - Pregnancy Or Breast Feeding
As with any drug, ask a doctor before use if pregnant or breast-feeding.
Otc - Ask Doctor
Consult a physician if: ■ symptoms persist for more than 7 days or worsen.
■ sensitive to quinine.
Otc - Keep Out Of Reach Of Children
Keep this and all medications out of the reach of children.
Other
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.
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 | Swallow 1-2 caplets with water every 4 hours. If the initial dosage is not providing relief, swallow 1-2 caplets with water 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
Lactose, Magnesium Stearate, Microcrystalline Cellulose.
Questions Or Comments?
(800) 624-9659
Dosage And Administration
Adults and children 12 years and over | Swallow 1-2 caplets with water every 4 hours. If the initial dosage is not providing relief, swallow 1-2 caplets with water every 15 minutes, up to 6 doses. |
Under 12 years of age | Consult a physician. |
Indications And Usage
■ Temporarily relieves the symptoms of:
■ stiffness ■ pain in limbs, joints or legs ■ cramps in calves, feet or legs
Principal Display Panel - 40 Caplet Bottle Carton
HOMEOPATHIC
NDC 54973-3114-2
Natural
Relief
SINCE 1903
Hyland's
Leg
Cramps
Relax Calf &
Foot Cramps
BOSTON ATHLETIC ASSOCIATION
BOSTON MARATHON
OFFICIAL
SPONSOR
40 CAPLETS
*SEE NOTE ON BACK PANEL
BELOW DRUG FACTS
* Please review the disclaimer below.
