Restful Legs: Homeopathic Product Information

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

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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

*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

Carton
(click image for full-size original)
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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ARSENIC TRIOXIDE (ARSENIC CATION (3+)) ARSENIC TRIOXIDE 12 [hp_X]
LYCOPODIUM CLAVATUM SPORE (LYCOPODIUM CLAVATUM SPORE) LYCOPODIUM CLAVATUM SPORE 6 [hp_X]
PULSATILLA VULGARIS (PULSATILLA VULGARIS) PULSATILLA VULGARIS 6 [hp_X]
TOXICODENDRON PUBESCENS LEAF (TOXICODENDRON PUBESCENS LEAF) TOXICODENDRON PUBESCENS LEAF 6 [hp_X]
SULFUR (SULFUR) SULFUR 6 [hp_X]
ZINC (ZINC) ZINC 12 [hp_X]
Inactive Ingredients
Ingredient Name Strength
LACTOSE
Product Characteristics
Color white Score no score
Shape ROUND Size 9mm
Flavor Imprint Code NONE
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54973-3162-1 1 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC
1 50 TABLET, SOLUBLE in 1 BOTTLE, PLASTIC This package is contained within the CARTON (54973-3162-1)
2 NDC:54973-3162-2 4 TABLET, SOLUBLE in 1 PACKET None
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 Operations
Standard Homeopathic Company 008316655 manufacture (54973-3162)
Establishment
Name Address ID/FEI Operations
Standard Homeopathic Company 080253323 manufacture (54973-3162), pack (54973-3162), label (54973-3162)
Establishment
Name Address ID/FEI Operations
MeriCal, Inc. 118445308 manufacture (54973-3162)

Revised: 07/2020 Hyland’s

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