RESTFUL LEGS- arsenic trioxide, lycopodium clavatum spore, pulsatilla vulgaris, toxicodendron pubescens leaf, sulfur, and zinc tablet, soluble

Restful Legs by

Drug Labeling and Warnings

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

Drug Details [pdf]

Drug Facts

Active ingredients

Arsenicum Album 12X 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

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 symptoms of: agitation or compelling urge to jerk or move legs itching, tingling, or crawling sensations in the 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 persist for more than 7 days or worsen or you think you may have Restless Leg Syndrome.

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

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 days per week at (800) 624-9659.

Directions

• Adults and Children 12 years and over:

  Dissolve 2-3 tablets under tongue every 4 hours, for up to 6 doses.

• Children 6 years to under 12 years:

  Dissolve 1-2 tablets under tongue every 4 hours, for up tp 6 doses.

Inactive Ingredients

Acacia Gum, Lactose.

Questions or comments?

(800) 624-9659

SPL UNCLASSIFIED SECTION

*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE,

NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.

PRINCIPAL DISPLAY PANEL - 50 Tablet Bottle Carton

NDC: 54973-3162-1

HOMEOPATHIC

Natural
Relief

SINCE 1903

Hyland's

Restful Legs™

Calms agitated legs to help you rest*

ACTUAL SIZE

194 MG

Relieves**

Itching, Crawling,

Tingling Sensation in Legs

Urge to Move Legs

Leg Jerks

50
QUICK-DISSOLVING
TABLETS

INGREDIENTS AND APPEARANCE

RESTFUL LEGS 
arsenic trioxide, lycopodium clavatum spore, pulsatilla vulgaris, toxicodendron pubescens leaf, sulfur, and zinc tablet, soluble

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54973-3162
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]
LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479)	LYCOPODIUM CLAVATUM SPORE	6 [hp_X]
PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV)	PULSATILLA VULGARIS	6 [hp_X]
TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A)	TOXICODENDRON PUBESCENS LEAF	6 [hp_X]
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	6 [hp_X]
ZINC (UNII: J41CSQ7QDS) (ZINC - UNII:J41CSQ7QDS)	ZINC	12 [hp_X]

Inactive Ingredients
Ingredient Name	Strength
LACTOSE (UNII: J2B2A4N98G)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	9mm
Flavor		Imprint Code	NONE
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54973-3162-1	1 in 1 CARTON	07/17/2006
1		50 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC: 54973-3162-2	4 in 1 PACKET; Type 0: Not a Combination Product	07/17/2006

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		07/17/2006

Labeler - Hyland's (028570695)

Establishment
Name	Address	ID/FEI	Business Operations
Standard Homeopathic Company		008316655	manufacture(54973-3162)

Establishment
Name	Address	ID/FEI	Business Operations
MeriCal, Inc.		118445308	manufacture(54973-3162)