FDA.reportPublic FDA data

Relaxing Legs

Manufacturer
The Magni Company | Apotheca Company
Effective date
2024-02-08
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 02:26:01

Label at a glance#

ProductRelaxing Legs
Active ingredientACONITUM NAPELLUS WHOLE, PSEUDOGNAPHALIUM OBTUSIFOLIUM WHOLE, RHODODENDRON TOMENTOSUM LEAFY TWIG, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, TOXICODENDRON PUBESCENS LEAF, VISCUM ALBUM FRUITING TOP
Label structure10 sections

Indications and uses

Temporary relief of leg discomfort with accompanying sleeplessness.

Dosage and administration

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.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

Aconitum Napellus 6X, Gnaphalium Polycephalum 4X, Ledum Palustre 6X, Magnesia Phosphorica 6X, Rhus Tox, 6X, Viscum Album 4X.

USES:

OTC - PURPOSE SECTION

Temporary relief of leg discomfort with accompanying sleeplessness.

WARNINGS:

WARNINGS SECTION

• 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:

OTHER SAFETY INFORMATION

• Store tightly closed in a dry place.

• Tamper sealed: Sealed for your protection. Do not use if seal is broken or missing

• The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopeia of the United

   States

• These statements are supported by the traditional homeopathic principles

KEEP OUT OF REACH OF CHILDREN:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

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.

INDICATIONS:

INDICATIONS & USAGE SECTION

Temporary relief of leg discomfort with accompanying sleeplessness.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Lactose, Magnesium Stearate, Microcrystalline Cellulose

QUESTIONS:

OTC - QUESTIONS SECTION

Dist. by: The Magni Group, Inc. McKinney, TX 75071 USA
www.magnilife.com      1-800-645-9199

PACKAGE DISPLAY LABEL:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MAGNILIFE Homeopathic

NDC 43689-0021-1

RELAXING LEGS

Pain Reliever

Nighttime Sleep Aid

√ Unpleasant Sensations

√ Difficulty Falling Asleep

√ Restlessness

√ Pain

√ Discomfort

125 Dissolving Tablets

Relaxing Legs lblRelaxing Legs lbl

Relaxing Legs ctnRelaxing Legs ctn

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6e3c022f-0786-43f1-8857-edff89d5153fProduct name120260309
95250459-30e4-45c1-b08a-993044f49109Product name220250805
efd58652-cb8f-4018-91ca-4b0eb2ff729fProduct name720240226
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
2641ccb3-721d-4fbf-9f2f-ca2f18157a62Product name320210309
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
e7e58cd3-cacb-49df-8d34-1ee335614abbProduct name120150609
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43689-0021-22024-02-08C16284748780-1ba0f9c33-3d11-a910-e053-dadaa90a0b85DRUG FACTS:
43689-0021-22024-01-30C16284748780-1ba0f9c33-3d11-a910-e053-dadaa90a0b85DRUG FACTS:
43689-0021-22022-01-10C16284748780-1ba0f9c33-3d11-a910-e053-dadaa90a0b85DRUG FACTS:
43689-0021-22021-01-29C16284748780-1ba0f9c33-3d11-a910-e053-dadaa90a0b85DRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43689-0021-1Relaxing Legs125 in 1 BOTTLELIQUID1255
43689-0021-2Relaxing Legs1 in 1 CARTONLIQUID15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43689-0021RELAXING LEGS (ACONITUM NAPELLUS, GNAPHALIUM POLYCEPHALUM, LEDUM PALUSTRE, MAGNESIA PHOSPHORICA, RHUS TOX, VISCUM ALBUM) LIQUID [THE MAGNI COMPANY]5Current NDC, Legacy NDC, 2 package rows20240209_800257d9-c0fb-4c71-a2c7-20602523e4ac.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43689-002143689-0021-1, 43689-0021-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACONITUM NAPELLUS WHOLEU0NQ8555JDACTIB
PSEUDOGNAPHALIUM OBTUSIFOLIUM WHOLE36XQ854NWWACTIB
RHODODENDRON TOMENTOSUM LEAFY TWIG877L01IZ0PACTIB
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATEHF539G9L3QACTIB
TOXICODENDRON PUBESCENS LEAF6IO182RP7AACTIB
VISCUM ALBUM FRUITING TOPBK9092J5MPACTIB
LACTOSEJ2B2A4N98GIACT
MAGNESIUM STEARATE70097M6I30IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT

Source Document#

Source XML

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
Relaxing LegsACONITUM NAPELLUS, GNAPHALIUM POLYCEPHALUM, LEDUM PALUSTRE, MAGNESIA PHOSPHORICA, RHUS TOX, VISCUM ALBUMThe Magni Company800257d9-c0fb-4c71-a2c7-20602523e4ac2024-02-08WarningsExact identifier
ndc (package): 43689-0021-1
ndc (package): 43689-0021-2
ndc (product): 43689-0021
ndc11 (package): 43689002101
ndc11 (package): 43689002102
spl id: 03549715-f48c-4fc5-a824-2725dfea3f47
spl set id: 800257d9-c0fb-4c71-a2c7-20602523e4ac

Reported adverse events (FAERS/openFDA)#

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