Restless Legs Relief
- Manufacturer
- Apotheca Company
- Effective date
- 2011-05-16
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-06-01 02:03:09
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
ACTIVE INGREDIENTS: Gnaphalium polycephalum 4X, Viscum album 4X, Aconitum napellus 6X, Ledum palustre 6X, Magnesia phosphorica 6X, Rhus toxicodendron 6X.
OTC - PURPOSE SECTION
USES: Temporarily relieves uncomfortable sensations in the legs that urge one to move during periods of inactivity, such as sleep.
WARNINGS SECTION
WARNINGS: If pregnant or breastfeeding, ask a health professional before use.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
OTHER INFORMATION: Tamper Sealed: Sealed for your protection. Do not use if seal is broken or missing.
Store tightly closed in a cool, dry place. (59-86 degrees f).
The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopeia of the United States.
DOSAGE & ADMINISTRATION SECTION
DIRECTIONS: Adults and children 12 years and above: Dissolve 2 tablets under tongue 2 to 3 times daily or as directed by a physician.
Children under 12 years: Consult a physician.
INACTIVE INGREDIENT SECTION
INACTIVE INGREDIENTS: Lactose, Magnesium stearate, Microcrystalline cellulose.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
KEEP OUT OF REACH OF CHILDREN. In case of overdose, get medical help or contact a Poison Control Center right away.
INDICATIONS & USAGE SECTION
USES: Temporarily relieves uncomfortable sensations in the legs that urge one to move during periods of inactivity, such as sleep.
OTC - QUESTIONS SECTION
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
MAGNILIFE
NDC 57520-0424-1
Homeopathic
RESTLESS LEGS RELIEF
For Uncontrollable Urges to Move the Legs
125 Tablets
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 57520-0424-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-70b7-f424-e053-dadaa90a57ce | Restless Legs Relief |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 57520-0424-1 | Restless Legs Relief | 125 in 1 BOTTLE | TABLET | 125 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 57520-0424 | RESTLESS LEGS RELIEF (GNAPHALIUM POLYCEPHALUM, VISCUM ALBUM, ACONITUM NAPELLUS, LEDUM PALUSTRE, MAGNESIA PHOSPHORICA, RHUS TOXICODENDRON,) TABLET [APOTHECA COMPANY] | 2 | Legacy NDC, 1 package rows | 20110517_256fba47-1a4d-475f-84be-a6b36d63a096.zip |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| ACONITUM NAPELLUS | ACTIVE INGREDIENT | U0NQ8555JD | 2 | |
| LEDUM PALUSTRE TWIG | ACTIVE INGREDIENT | 877L01IZ0P | 2 | |
| MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE | ACTIVE INGREDIENT | HF539G9L3Q | 2 | |
| PSEUDOGNAPHALIUM OBTUSIFOLIUM | ACTIVE INGREDIENT | 36XQ854NWW | 2 | |
| TOXICODENDRON PUBESCENS LEAF | ACTIVE INGREDIENT | 6IO182RP7A | 2 | |
| VISCUM ALBUM FRUITING TOP | ACTIVE INGREDIENT | BK9092J5MP | 2 | |
| ACONITUM NAPELLUS | ACTIVE MOIETY | U0NQ8555JD | 2 | |
| LEDUM PALUSTRE TWIG | ACTIVE MOIETY | 877L01IZ0P | 2 | |
| MAGNESIUM CATION | ACTIVE MOIETY | T6V3LHY838 | 2 | |
| PSEUDOGNAPHALIUM OBTUSIFOLIUM | ACTIVE MOIETY | 36XQ854NWW | 2 | |
| TOXICODENDRON PUBESCENS LEAF | ACTIVE MOIETY | 6IO182RP7A | 2 | |
| VISCUM ALBUM FRUITING TOP | ACTIVE MOIETY | BK9092J5MP | 2 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | 2 | |
| LACTOSE | INACTIVE INGREDIENT | J2B2A4N98G | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | 2 |
Products#
Every source-derived product name is available through these pages.
- Restless Legs Relief
- Gnaphalium polycephalum, Viscum album, Aconitum napellus, Ledum palustre, Magnesia phosphorica, Rhus toxicodendron,
- PSEUDOGNAPHALIUM OBTUSIFOLIUM
- VISCUM ALBUM FRUITING TOP
- ACONITUM NAPELLUS
- LEDUM PALUSTRE TWIG
- MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE
- MAGNESIUM CATION
- TOXICODENDRON PUBESCENS LEAF
- CELLULOSE, MICROCRYSTALLINE
- LACTOSE
- MAGNESIUM STEARATE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 57520-0424 | 57520-0424-1 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| PSEUDOGNAPHALIUM OBTUSIFOLIUM | 36XQ854NWW | ACTIB |
| VISCUM ALBUM FRUITING TOP | BK9092J5MP | ACTIB |
| ACONITUM NAPELLUS | U0NQ8555JD | ACTIB |
| LEDUM PALUSTRE TWIG | 877L01IZ0P | ACTIB |
| MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE | HF539G9L3Q | ACTIB |
| TOXICODENDRON PUBESCENS LEAF | 6IO182RP7A | ACTIB |
| CELLULOSE, MICROCRYSTALLINE | OP1R32D61U | IACT |
| LACTOSE | J2B2A4N98G | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
Source Document#
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.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| LACTOSE | LACTOSE | J2B2A4N98G | POWDER, FOR SOLUTION / ORAL | NA | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 53 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, FILM COATED / ORAL | 992 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | POWDER / TOPICAL | 104 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | SUPPOSITORY / VAGINAL | NA | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | DROPS / ORAL | NA | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET / BUCCAL | 17.5 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | OINTMENT / TOPICAL | NA | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | CAPSULE / ORAL | 2169 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | WAFER / ORAL | 66 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET / ORAL | 6184 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | PELLET / ORAL | 24 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, COATED / ORAL | 184 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, DELAYED RELEASE / ORAL | 144 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, EXTENDED RELEASE / ORAL | 173 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, FOR SUSPENSION / ORAL | 20100 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | POWDER / RESPIRATORY (INHALATION) | 0.13 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | POWDER, FOR SUSPENSION / ORAL | 120 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, CHEWABLE / ORAL | 127 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET / SUBLINGUAL | 43.2 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | TABLET / ORAL | 2500 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TROCHE / ORAL | 300 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | TABLET, COATED / ORAL | 332.05 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, ORALLY DISINTEGRATING / ORAL | 1800 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | TABLET, CHEWABLE / ORAL | 1412 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | CAPSULE / ORAL | 530 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 1576 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, DELAYED RELEASE PARTICLES / ORAL | 580 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | POWDER / VAGINAL | 430 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | FILM, EXTENDED RELEASE / TRANSDERMAL | 675 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | CAPSULE, DELAYED RELEASE / ORAL | 366 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | CREAM / TOPICAL | NA | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, ORALLY DISINTEGRATING / ORAL | 187 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | TABLET / RECTAL | 20 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | CAPSULE, EXTENDED RELEASE / ORAL | 1246 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | TABLET / SUBLINGUAL | 352 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | TABLET, SUGAR COATED / ORAL | NA | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | POWDER, FOR SOLUTION / ORAL | 690 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, COATED / ORAL | 920 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | GRANULE, FOR SUSPENSION / ORAL | 512.5 mg/5ml | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, EXTENDED RELEASE / ORAL | 5119 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | IMPLANT / SUBCUTANEOUS | 0.5 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, DELAYED RELEASE / ORAL | 2210 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR | 133 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, FILM COATED / ORAL | 96 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TROCHE / ORAL | 315 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | LOZENGE / ORAL | 420 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | CREAM / VAGINAL | 3 %w/w | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | CAPSULE, DELAYED RELEASE / ORAL | 1060 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IMPLANT / INTRAVITREAL | 1.66 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | CONCENTRATE / ORAL | NA | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | CAPSULE, COATED PELLETS / ORAL | 456 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | GRANULE, FOR SUSPENSION / ORAL | 278 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET / BUCCAL | 18 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS | 133 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, FOR SUSPENSION / ORAL | 131 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, CHEWABLE / ORAL | 1725 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | INSERT / VAGINAL | 69 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | POWDER / RESPIRATORY (INHALATION) | 90 mg |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| a434d123-4144-40a0-8914-0cdbf3eeea31 | 256fba47-1a4d-475f-84be-a6b36d63a096 | 2011-05-16 | Warnings | a434d123-4144-40a0-8914-0cdbf3eeea31 256fba47-1a4d-475f-84be-a6b36d63a096 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
