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
14 label sections · Submitted to the FDA by Hyland's Inc. · 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, otc - active ingredient, ask a doctor before use if you are, if pregnant or breastfeeding, stop use and ask a doctor if, keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Drug Facts
Otc - Active Ingredient
| 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 the active ingredients are in the official Homeopathic Pharmacopœia of the United States.
Ask A Doctor Before Use If You Are
sensitive to quinine.
If Pregnant Or Breastfeeding
ask a health professional before use.
Stop Use And Ask A Doctor If
symptoms persist for more than 7 days or worsen.
Keep Out Of Reach Of Children
Directions
■ Use as directed.
| Adults and children
12 years 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 15 minutes until relieved, up to 6 doses. |
| Children under
12 years of age | Ask a doctor before use. |
Inactive Ingredients
Lactose, Magnesium Stearate, Microcrystalline Cellulose.
Questions?
www.hylands.com or [email protected]
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
Uses
■ Helps temporarily relieve symptoms of:
■ stiness ■ pain in limbs, joints or legs ■ cramps in calves, feet or legs
Principal Display Panel
Hyland's
NATURALS
LEG
CRAMPS
EFFECTIVE RELIEF*
100
CAPLETS
HOMEOPATHIC
Carton. (Legcramps C100)
* Please review the disclaimer below.
