RESTFUL LEGS PM- anemone patens,matricaria chamomilla,sulfur,zinc,toxicodendron pubescens leaf,arsenic trioxide,arabica coffee bean,lycopodium clavatum spore tablet

Restful Legs PM by

Drug Labeling and Warnings

Restful Legs PM by is a Homeopathic medication manufactured, distributed, or labeled by Hyland's Inc., Hyland's Consumer Health Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Arsenicum Album 12X HPUS

Chamomilla 3X HPUS

Coffea Cruda 3X HPUS

Lycopodium 6X HPUS

Pulsatilla 6X HPUS

Rhus Toxicodendron 6X HPUS

Sulphur 6X HPUS

Zincum Metallicum 12X HPUS

“HPUS” indicates that the active ingredients are in the official Homeopathic Pharmacopœia of the United States.

Purpose

creeping, crawling itch

occasional sleeplessness, disrupted sleep

occasional sleeplessness

feeling of agitation while lying down

constant urge to move legs

agitation, better with activity

itching, tingling, and urge to move legs

twitching and jerking of legs while sitting

Uses

Temporarily relieves occasional sleeplessness or dirupted sleep due to: agitation or compelling urge to jerk or move legs

itching, tingling, or crawling sensations in legs

Warnings

As with any drug, ask doctor before use if pregnant or breast-feeding.

Do not use more than directed

Consult a physician if symptoms persis for more than 7 days or worsen or you think you may have Restless Leg Syndrone.

Keep this and all medications out of the reach of children.

Do not use if imprinted tamper-evident bottle cap band is broken or missing.

In case of emergency, or accidental overdose, 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 at bedtime and

  every 4 hours during the night until relieved.

• Children 6 years to under 12 years:

  Dissolve 1-2 tablets under tongue at bedtime and

  every 4 hours during the night until relieved.

Inactive Ingredients

Acacia Gum, Lactose.

Questions or comments?

(800) 624-9659

SPL UNCLASSIFIED SECTION

*CLAIMS ON TRADITIONAL HOMEOPATHIC PRACTICE,

NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.

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

Relieves**

Itching, Crawling,

Tingling Sensation in Legs

Urge to Move Legs

Occasional Sleeplessness

50

QUICK-DISSOLVING

TABLETS ACTUAL SIZE 194 MG

INGREDIENTS AND APPEARANCE

RESTFUL LEGS PM 
anemone patens,matricaria chamomilla,sulfur,zinc,toxicodendron pubescens leaf,arsenic trioxide,arabica coffee bean,lycopodium clavatum spore tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54973-3352
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV)	ARSENIC TRIOXIDE	12 [hp_X]
MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ)	MATRICARIA CHAMOMILLA	3 [hp_X]
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	6 [hp_X]
ZINC (UNII: J41CSQ7QDS) (ZINC - UNII:J41CSQ7QDS)	ZINC	12 [hp_X]
ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72)	ARABICA COFFEE BEAN	3 [hp_X]
LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479)	LYCOPODIUM CLAVATUM SPORE	6 [hp_X]
ANEMONE PATENS (UNII: 4M1169RWJD) (ANEMONE PATENS - UNII:4M1169RWJD)	ANEMONE PATENS	6 [hp_X]
TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A)	TOXICODENDRON PUBESCENS LEAF	6 [hp_X]

Inactive Ingredients
Ingredient Name	Strength
ACACIA (UNII: 5C5403N26O)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)

Product Characteristics
Color	white (Off-White to Light Beige)	Score	no score
Shape	ROUND	Size	9mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54973-3352-1	1 in 1 CARTON	03/14/2018
1		50 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC: 54973-3352-2	4 in 1 PACKET; Type 0: Not a Combination Product	03/14/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		03/14/2018

Labeler - Hyland's (028570695)

Establishment
Name	Address	ID/FEI	Business Operations
Standard Homeopathic Campany		008316655	manufacture(54973-3352) , pack(54973-3352) , label(54973-3352)