Restful Legs

Manufacturer: Hyland's Inc. | MeriCal, Inc.
Effective date: 2026-08-11
Label type: HUMAN OTC DRUG LABEL
Version: 10
Source: daily-update
Hydrated at: 2026-08-14 00:01:05

Label at a glance#

ProductRestful Legs

Active ingredientARSENIC TRIOXIDE, LYCOPODIUM CLAVATUM SPORE, PULSATILLA VULGARIS, TOXICODENDRON PUBESCENS LEAF, SULFUR, ZINC

Label structure10 sections

Indications and uses

■ Helps temporarily relieves occasional symptoms of: ■ agitation or compelling urge to jerk or move legs ■ itching, tingling, or crawling sensations in the legs

Dosage and administration

■ Use as directed. Adults and children 12 years and over At onset of symptoms, dissolve 2-3 tablets under tongue every 4 hours until relieved. Children 6 years to under 12 years At onset of symptoms, dissolve 1-2 tablets under tongue every 4 hours until relieved.

Contacts and useful links#

Websitewww.hylands.com

www.hylands.com

Label contents#

Full prescribing information#

OTC - PURPOSE SECTION

Temporarily relieves occasional symptoms of: agitation or compelling urge to jerk or move legs, creeping, crawling, itching, twitching or tingling sensation in legs.

Drug Facts

SPL UNCLASSIFIED SECTION

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

*Active ingredients*	*Purpose*
Arsenicum Album 12X HPUS (0.000000000076% Arsenic, calculated)	creeping, crawling itch
Lycopodium 6X HPUS	feeling of agitation while lying down
Pulsatilla 6X HPUS	constant urge to move legs
Rhus Toxicodendron 6X HPUS	agitation, better with activity
Sulphur 6X HPUS	itching, tingling and urge to move legs
Zincum Metallicum 12X HPUS	twitching and jerking of legs while sitting

"HPUS" is the Homeopathic Pharmacopoeia of the United States.

Uses

INDICATIONS & USAGE SECTION

■ Helps temporarily relieves occasional symptoms of:

■ agitation or compelling urge to jerk or move legs

■ itching, tingling, or crawling sensations in the legs

Directions

DOSAGE & ADMINISTRATION SECTION

■ Use as directed.

Adults and children 12 years and over	At onset of symptoms, dissolve 2-3 tablets under tongue every 4 hours until relieved.
Children 6 years to under 12 years	At onset of symptoms, dissolve 1-2 tablets under tongue every 4 hours until relieved.

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Acacia Gum, Lactose.

Questions?

OTC - QUESTIONS SECTION

www.hylands.com or care@hylands.com

Dosage and Administration

RECENT MAJOR CHANGES SECTION

added bullets

Indications and Usage

RECENT MAJOR CHANGES SECTION

Uses

Helps temporarily relieve occasional symptoms of:
agitation or compelling urge to jerk or move legs
creeping, crawling, itching, twitching or tingling sensation in legs

PRINCIPAL DISPLAY PANEL- Restful Legs 50 Count

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Hyland's

^NATURALS™

RESTFUL

LEGS

FAST + EFFECTIVE RELIEF*

Calms agitated

legs so you

can rest**

^{QUICK-DISSOLVING}

^TABLETS

HOMEOPATHIC

HRES00000T50LBLH2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
63f39a63-5cd1-4016-bd86-2bbb0f6c3139	Product name	3	20240506
e5a77e9c-c528-733a-173d-914a234c024b	Product name	5	20240506

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
54973-3162-1	2022-11-07	C162847	48780-1	e4f33bdf-a678-d8a0-e053-dadaa90a6e4e	Restful Legs
54973-3162-1	2022-11-07	C162847	48780-1	e4f33bdf-a678-d8a0-e053-dadaa90a6e4e	Restful Legs
54973-3162-2	2022-11-07	C162847	48780-1	e4f33bdf-a678-d8a0-e053-dadaa90a6e4e	Restful Legs
54973-3162-2	2022-11-07	C162847	48780-1	e4f33bdf-a678-d8a0-e053-dadaa90a6e4e	Restful Legs
54973-3162-1	2022-07-29	C162847	48780-1	e4f33bdf-a678-d8a0-e053-dadaa90a6e4e	Restful Legs
54973-3162-1	2022-07-29	C162847	48780-1	e4f33bdf-a678-d8a0-e053-dadaa90a6e4e	Restful Legs
54973-3162-2	2022-07-29	C162847	48780-1	e4f33bdf-a678-d8a0-e053-dadaa90a6e4e	Restful Legs
54973-3162-2	2022-07-29	C162847	48780-1	e4f33bdf-a678-d8a0-e053-dadaa90a6e4e	Restful Legs

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
54973-3162-1	EA - Each	54973-3162	a0a89851-6903-40fc-bf53-8e57eb20f662	1	2023-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
ARSENIC TRIOXIDE	ACTIVE INGREDIENT	S7V92P67HO	1
LYCOPODIUM CLAVATUM SPORE	ACTIVE INGREDIENT	C88X29Y479	1
PULSATILLA VULGARIS	ACTIVE INGREDIENT	I76KB35JEV	1
SULFUR	ACTIVE INGREDIENT	70FD1KFU70	1
TOXICODENDRON PUBESCENS LEAF	ACTIVE INGREDIENT	6IO182RP7A	1
ZINC	ACTIVE INGREDIENT	J41CSQ7QDS	1
ARSENIC CATION (3+)	ACTIVE MOIETY	C96613F5AV	1
LYCOPODIUM CLAVATUM SPORE	ACTIVE MOIETY	C88X29Y479	1
PULSATILLA VULGARIS	ACTIVE MOIETY	I76KB35JEV	1
SULFUR	ACTIVE MOIETY	70FD1KFU70	1
TOXICODENDRON PUBESCENS LEAF	ACTIVE MOIETY	6IO182RP7A	1
ZINC	ACTIVE MOIETY	J41CSQ7QDS	1
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	1

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

Restful Legs
arsenic trioxide, lycopodium clavatum spore, pulsatilla vulgaris, toxicodendron pubescens leaf, sulfur, and zinc
ARSENIC TRIOXIDE
ARSENIC CATION (3+)
LYCOPODIUM CLAVATUM SPORE
PULSATILLA VULGARIS
TOXICODENDRON PUBESCENS LEAF
SULFUR
ZINC
LACTOSE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
54973-3162	54973-3162-1, 54973-3162-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ARSENIC TRIOXIDE	S7V92P67HO	ACTIB
LYCOPODIUM CLAVATUM SPORE	C88X29Y479	ACTIB
PULSATILLA VULGARIS	I76KB35JEV	ACTIB
TOXICODENDRON PUBESCENS LEAF	6IO182RP7A	ACTIB
SULFUR	70FD1KFU70	ACTIB
ZINC	J41CSQ7QDS	ACTIB
LACTOSE	J2B2A4N98G	IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
Version	Effective date	Source	Hydrated
9	2025-02-06	full-release	2026-06-01 02:31:47

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 54 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
LACTOSE	LACTOSE	J2B2A4N98G	CAPSULE, COATED PELLETS / ORAL	135.2 mg		Exact identifier — unii+route 54 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET, DELAYED RELEASE / ORAL		160 mg	Exact identifier — unii+route 54 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET, COATED / ORAL	332.05 mg		Exact identifier — unii+route 54 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET, EXTENDED RELEASE / ORAL	400 mg		Exact identifier — unii+route 54 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	CONCENTRATE / ORAL	NA		Exact identifier — unii+route 54 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET, DELAYED RELEASE / ORAL		160 mg	Exact identifier — unii+route 54 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii+route 54 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET, EFFERVESCENT / ORAL	96.5 mg		Exact identifier — unii+route 54 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	CAPSULE, COATED PELLETS / ORAL	135.2 mg		Exact identifier — unii+route 54 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	CAPSULE, EXTENDED RELEASE / ORAL	120 mg		Exact identifier — unii+route 54 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET, CHEWABLE / ORAL		1412 mg	Exact identifier — unii+route 54 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		620 mg	Exact identifier — unii+route 54 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	POWDER, FOR SOLUTION / ORAL	NA		Exact identifier — unii+route 54 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	CAPSULE, COATED PELLETS / ORAL	135.2 mg		Exact identifier — unii+route 54 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		620 mg	Exact identifier — unii+route 54 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	CAPSULE, DELAYED RELEASE / ORAL	231.84 mg		Exact identifier — unii+route 54 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET, EFFERVESCENT / ORAL	96.5 mg		Exact identifier — unii+route 54 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET, COATED / ORAL	332.05 mg		Exact identifier — unii+route 54 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET, COATED / ORAL	332.05 mg		Exact identifier — unii+route 54 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET / ORAL	2500 mg		Exact identifier — unii+route 54 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET, CHEWABLE / ORAL		1412 mg	Exact identifier — unii+route 54 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii+route 54 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET, DELAYED RELEASE / ORAL		160 mg	Exact identifier — unii+route 54 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	SOLUTION / ORAL	1682 mg/15ml		Exact identifier — unii+route 54 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	CONCENTRATE / ORAL	NA		Exact identifier — unii+route 54 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	CAPSULE, EXTENDED RELEASE / ORAL	120 mg		Exact identifier — unii+route 54 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET, SUGAR COATED / ORAL	NA		Exact identifier — unii+route 54 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	GRANULE, FOR SUSPENSION / ORAL	512.5 mg/5ml		Exact identifier — unii+route 54 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	SOLUTION / ORAL	1682 mg/15ml		Exact identifier — unii+route 54 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		620 mg	Exact identifier — unii+route 54 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	CAPSULE, EXTENDED RELEASE / ORAL	120 mg		Exact identifier — unii+route 54 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET, SUGAR COATED / ORAL	NA		Exact identifier — unii+route 54 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET, SUGAR COATED / ORAL	NA		Exact identifier — unii+route 54 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET, FILM COATED / ORAL	590 mg		Exact identifier — unii+route 54 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET, EFFERVESCENT / ORAL	96.5 mg		Exact identifier — unii+route 54 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	GRANULE, FOR SUSPENSION / ORAL	512.5 mg/5ml		Exact identifier — unii+route 54 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	SOLUTION / ORAL	1682 mg/15ml		Exact identifier — unii+route 54 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET, EXTENDED RELEASE / ORAL	400 mg		Exact identifier — unii+route 54 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii+route 54 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	CONCENTRATE / ORAL	NA		Exact identifier — unii+route 54 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	POWDER, FOR SOLUTION / ORAL	NA		Exact identifier — unii+route 54 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	CAPSULE, DELAYED RELEASE / ORAL	231.84 mg		Exact identifier — unii+route 54 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	CAPSULE / ORAL	530 mg		Exact identifier — unii+route 54 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET, CHEWABLE / ORAL		1412 mg	Exact identifier — unii+route 54 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	CAPSULE / ORAL	530 mg		Exact identifier — unii+route 54 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	POWDER, FOR SOLUTION / ORAL	NA		Exact identifier — unii+route 54 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	CAPSULE / ORAL	530 mg		Exact identifier — unii+route 54 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET / ORAL	2500 mg		Exact identifier — unii+route 54 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET, FILM COATED / ORAL	590 mg		Exact identifier — unii+route 54 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	CAPSULE, DELAYED RELEASE / ORAL	231.84 mg		Exact identifier — unii+route 54 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET, EXTENDED RELEASE / ORAL	400 mg		Exact identifier — unii+route 54 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET / ORAL	2500 mg		Exact identifier — unii+route 54 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET, FILM COATED / ORAL	590 mg		Exact identifier — unii+route 54 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	GRANULE, FOR SUSPENSION / ORAL	512.5 mg/5ml		Exact identifier — unii+route 54 equally ranked IID candidates

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Restful Legs	ARSENIC TRIOXIDE, LYCOPODIUM CLAVATUM SPORE, PULSATILLA VULGARIS, TOXICODENDRON PUBESCENS LEAF, SULFUR, AND ZINC	Hyland's Inc.	36e5843c-916a-425c-becc-15674cda7a65	2026-08-11	Warnings	Exact identifier ndc (package): 54973-3162-2 ndc (package): 54973-3162-1 ndc (product): 54973-3162 ndc11 (package): 54973316201 ndc11 (package): 54973316202 spl id: 58cd6c9a-33fc-24eb-e063-6394a90a6984 spl set id: 36e5843c-916a-425c-becc-15674cda7a65

Reported adverse events (FAERS/openFDA)#

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