FDA Label for Restful Legs Pm
View Indications, Usage & Precautions
Restful Legs 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
Active Ingredients | Purpose |
Arsenicum Album 12X HPUS | creeping, crawling itch |
Chamomilla 3X HPUS | occasional sleeplessness, disrupted sleep |
Coffea Cruda 3X HPUS | occasional sleeplessness |
Lycopodium 6X HPUS | feeling of agitation while lying down |
Pulsatilla 6X HPUS | constant urge to move legs |
Rhus Toxicodendron 6X HPUS | agitation, better with activity |
Sulphur 6X HPUS | itching, tingling, and urge to move legs |
Zincum Metallicum 12X HPUS | twitching and jerking of legs while sitting |
“HPUS” indicates that the active ingredients are in the official Homeopathic Pharmacopœia of the United States.
Uses
Temporarily relieves occasional symptoms of agitation and compelling urge to jerk or move legs to relieve itching, tingling, crawling sensations in the legs, with accompanying occasional sleeplessness and disrupted sleep.
Otc - Pregnancy Or Breast Feeding
As with any drug, ask doctor before use if pregnant or breast-feeding.
Otc - Do Not Use
Do not use: • more than directed • if you have a known allergy to any ingredient in this product
Do not use if imprinted tamper evident bottle band is broken or missing.
Otc - Ask Doctor
Consult a physician if symptoms persis for more than 7 days or worsen or you think you may have Restless Leg Syndrone.
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 Poison Control Center immediately.
Other
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 day per week at (800) 624-9659.
Directions
Adults and Children 12 years and over | Dissolve 2-3 tablets under tongue before bed to fall asleep, stay asleep, and relieve agitation of legs. If initial dose is not providing relief, dissolve 2-3 tablets under tongue every 15 minutes, for up to 6 doses. |
Children under 12 years of age | Consult a physician. |
Inactive Ingredients
Acacia Gum, Lactose.
Questions Or Comments?
(800) 624-9659
Principal Display Panel - 50 Tablet Bottle Carton
NDC 54973-3352-1
HOMEOPATHIC
Natural
Relief
SINCE 1903
Hyland's
Restful Legs™
Calms agitated legs so you can sleep*
PM
Safe&
Effective
Relief
Relieves**
Itching, Crawling,
Tingling Sensation in Legs
Urge to Move Legs
Occasional Sleeplessness
50
QUICK-DISSOLVING
TABLETS ACTUAL SIZE 194 MG
* Please review the disclaimer below.