FDA.reportPublic FDA data

Restful Legs PM

Manufacturer
Hyland's Inc. | Hyland's Consumer Health Inc.
Effective date
2026-08-11
Label type
HUMAN OTC DRUG LABEL
Version
12
Source
daily-update
Hydrated at
2026-08-14 00:01:04

Label at a glance#

ProductRestful Legs PM
Active ingredientARSENIC TRIOXIDE, MATRICARIA CHAMOMILLA, SULFUR, ZINC, ARABICA COFFEE BEAN, LYCOPODIUM CLAVATUM SPORE, PULSATILLA PATENS WHOLE, TOXICODENDRON PUBESCENS LEAF
Label structure8 sections

Indications and uses

■ Helps temporarily relieve occasional sleeplessness or disrupted sleep due to: ■ agitation or compelling urge to jerk or move legs ■ itching, tingling, or crawling sensations in legs

Dosage and administration

■ Use as directed. 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.

Label contents#

Full prescribing information#

Drug Facts

SPL UNCLASSIFIED SECTION

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

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

OTC - PURPOSE SECTION

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

INDICATIONS & USAGE SECTION

■ Helps temporarily relieve occasional sleeplessness or disrupted sleep due to:

■ agitation or compelling urge to jerk or move legs

■ itching, tingling, or crawling sensations in legs

Warnings

WARNINGS SECTION

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

Restless Leg Syndrome.

Stop use and ask a doctor if

OTC - STOP USE SECTION

symptoms persist for more than 7 days or worsen.

If pregnant or breastfeeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

Ask a health professional before use

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

■ Use as directed.

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

INACTIVE INGREDIENT SECTION

Acacia Gum, Lactose.

Indications and Usage

RECENT MAJOR CHANGES SECTION

Added bullets

Updated to

■ Helps temporarily relieve occasional sleeplessness or disrupted sleep due to:

■ agitation or compelling urge to jerk or move legs

■ itching, tingling, or crawling sensations in legs

Principal Display Panel- Restful Legs PM 50 Count

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Hyland's

NATURALS™

RESTFUL

LEGS PM

FAST + EFFECTIVE RELIEF*

Helps calm

agitated legs

so you can sleep**

50

QUICK-DISSOLVING

TABLETS

HOMEOPATHIC

RLPM00000T50LBLH2RLPM00000T50LBLH2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54973-3352-1EA - Each54973-3352bc83e5a5-7163-475f-8466-c68a59ec896c12023-06-06

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54973-335254973-3352-1, 54973-3352-2, 54973-3352-3, 54973-3352-4, 54973-3352-5

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
ARSENIC TRIOXIDES7V92P67HOACTIB
MATRICARIA CHAMOMILLAG0R4UBI2ZZACTIB
SULFUR70FD1KFU70ACTIB
ZINCJ41CSQ7QDSACTIB
ARABICA COFFEE BEAN3SW678MX72ACTIB
LYCOPODIUM CLAVATUM SPOREC88X29Y479ACTIB
PULSATILLA PATENS WHOLE4M1169RWJDACTIB
TOXICODENDRON PUBESCENS LEAF6IO182RP7AACTIB
ACACIA5C5403N26OIACT
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
112025-04-10full-release2026-06-01 02:33:13

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Restful Legs PMANEMONE PATENS,MATRICARIA CHAMOMILLA,SULFUR,ZINC,TOXICODENDRON PUBESCENS LEAF,ARSENIC TRIOXIDE,ARABICA COFFEE BEAN,LYCOPODIUM CLAVATUM SPOREHyland's Inc.67667af8-b27b-1511-e053-2991aa0a39882026-08-11WarningsExact identifier
ndc (package): 54973-3352-2
ndc (package): 54973-3352-5
ndc (package): 54973-3352-1
ndc (package): 54973-3352-4
ndc (package): 54973-3352-3
ndc (product): 54973-3352
ndc11 (package): 54973335203
ndc11 (package): 54973335201
ndc11 (package): 54973335204
ndc11 (package): 54973335202
ndc11 (package): 54973335205
spl id: 58cd2939-aaf5-d50a-e063-6294a90aba67
spl set id: 67667af8-b27b-1511-e053-2991aa0a3988

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.