FDA Label for Leg Cramps Pm
View Indications, Usage & Precautions
Leg Cramps Pm Product Label
The following document was submitted to the FDA by the labeler of this product Hyland's Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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.
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.