Restful Legs PM: Homeopathic Product Information

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

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

*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

Carton
(click image for full-size original)
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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ARSENIC TRIOXIDE (ARSENIC CATION (3+)) ARSENIC TRIOXIDE 12 [hp_X]
MATRICARIA CHAMOMILLA (MATRICARIA CHAMOMILLA) MATRICARIA CHAMOMILLA 3 [hp_X]
SULFUR (SULFUR) SULFUR 6 [hp_X]
ZINC (ZINC) ZINC 12 [hp_X]
ARABICA COFFEE BEAN (ARABICA COFFEE BEAN) ARABICA COFFEE BEAN 3 [hp_X]
LYCOPODIUM CLAVATUM SPORE (LYCOPODIUM CLAVATUM SPORE) LYCOPODIUM CLAVATUM SPORE 6 [hp_X]
PULSATILLA PATENS WHOLE (PULSATILLA PATENS WHOLE) PULSATILLA PATENS WHOLE 6 [hp_X]
TOXICODENDRON PUBESCENS LEAF (TOXICODENDRON PUBESCENS LEAF) TOXICODENDRON PUBESCENS LEAF 6 [hp_X]
Inactive Ingredients
Ingredient Name Strength
ACACIA
LACTOSE MONOHYDRATE (ANHYDROUS LACTOSE)
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 Multilevel Packaging
1 NDC:54973-3352-1 1 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC
1 50 TABLET in 1 BOTTLE, PLASTIC This package is contained within the CARTON (54973-3352-1)
2 NDC:54973-3352-2 4 TABLET in 1 PACKET None
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 Operations
Standard Homeopathic Campany 008316655 pack (54973-3352), label (54973-3352), manufacture (54973-3352)
Establishment
Name Address ID/FEI Operations
Standard Homeopathic Company 080253323 manufacture (54973-3352), pack (54973-3352), label (54973-3352)

Revised: 07/2020 Hyland’s

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