Otc - Purpose
Temporarily relieves the symptoms of pain and cramps in lower body, legs,calves, feet and toes with accompanying occasional sleeplessness and disrupted sleep.
Leg Cramps Pm Tablet, Soluble
FDA Label NDC 54973-3093
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 Pm (NDC 54973-3093). 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, other, otc - active ingredient, uses, otc - pregnancy or breast feeding, otc - keep out of reach of children, otc - do not use, in case of emergency, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Other
Drug Facts
Otc - Active Ingredient
| Active Ingredients | Purpose |
| Calcarea Carbonica 12X HPUS | cramps in legs, calves, feet and toes |
| Causticum 12X HPUS | occasional nocturnal sleeplessness |
| Chamomilla 6X HPUS | occasional sleeplessness |
| Cinchona Officinalis 3X HPUS | pain in limbs and joints; cramping in legs |
| Cuprum Metallicum 12X HPUS | cramps of limbs, charley horse cramps |
| Lycopodium 12X HPUS | disturbed, restless sleep |
| Magnesia Phosphorica 6X HPUS | muscle cramps |
| Rhus Toxicodendron 6X HPUS | pain and stiffness |
| Silicea 12X HPUS | not being able to sleep again after waking |
| Sulphur 6X HPUS | occasional sleeplessness, frequent waking during night |
“HPUS” indicates that the active ingredients are in the official Homeopathic Pharmacopœia of the United States.
Uses
Temporarily relieves the symptoms of pain and cramps in lower body, legs,calves, feet and toes with accompanying occasional sleeplessness and disrupted sleep.
Otc - Pregnancy Or Breast Feeding
As with any drug, ask a doctor before use if pregnant or breast-feeding. Consult a physician if:
- Symptoms percist 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. In case of accidental overdose, contact a medical professional or a poison control center immediately.
Otc - Do Not Use
Do not use if imprinted tamper band is broken or missing.
In Case Of Emergency
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 older: Dissolve 2-3 tablets under tongue before bed to fall asleep, stay asleep and relieve leg cramps. If the initial dosage is not providing relief, dissolve 2-3 tablets under tongue every 15 minutes, for up to 6 doses. Under 12 years of age: Consult a physician.
Inactive Ingredients
Acacia Gum, Lactose.
Otc - Questions
(800) 624-9659 www.hylands.com
Principal Display Panel - 50 Tablet Carton
NDC 54973-3093-1
HOMEOPATHIC
Natural
Relief
NON-HABIT
FORMING
SINCE 1903
Hyland's®
Leg
Cramps
PM
Nighttime
Cramp Relief *
#1 PHARMACIST
RECOMENDED
& WORLD REPORT
U.S. News
Parmacy
Times
LEG CRAMP RELIEF
ACTUAL SIZE
194 MG
50
QUICK-DISSOLVING
TABLETS
* Please review the disclaimer below.
