Restful Legs Pm Tablet
FDA Label NDC 54973-3352

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 Restful Legs Pm (NDC 54973-3352). 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, uses, otc - pregnancy or breast feeding, otc - do not use, otc - ask doctor, otc - keep out of reach of children, other, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Otc - Purpose

→ Uses

→ Otc - Pregnancy Or Breast Feeding

→ Otc - Do Not Use

→ Otc - Ask Doctor

→ Otc - Keep Out Of Reach Of Children

→ Other

→ Directions

→ Inactive Ingredients

→ Questions Or Comments?

→ Principal Display Panel - 50 Tablet Bottle Carton

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*

Safe&

Effective

Relief

Relieves**

Itching, Crawling,

Tingling Sensation in Legs

Urge to Move Legs

Occasional Sleeplessness

QUICK-DISSOLVING

TABLETS ACTUAL SIZE 194 MG

* Please review the disclaimer below.

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