FDA.reportPublic FDA data

Relax AM-PM

Manufacturer
Foster Regal Laboratories | Dee Cee Laboratories
Effective date
2025-01-06
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 02:30:06

Label at a glance#

ProductRelax AM-PM
Active ingredientVALERIAN, PASSIFLORA INCARNATA FLOWER, MAGNESIUM CARBONATE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

EACH TABLET CONTAINS:
6 parts Valerian Root (Quad-Strength) 1X, 3 parts Passiflora (Quad-Strength) 1X, 1 part Magnesium Carbonate 1X.

OTC - PURPOSE SECTION

For Relief of Muscle Spasms
Tension and Stress

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN. In case of accidental overdose seek professional assistance or contact a poison control center immediately.

INDICATIONS & USAGE SECTION

INDICATIONS: For temporary relief of muscle spasms, tension and stress.

WARNINGS SECTION

Warning: Do not give to children under twelve except under the advice and supervision of a doctor. If you are pregnant or nursing a baby seek the advice of a health professional before using this product. Do not exceed recommended dosage. Consult a doctor if symptoms are more than mild or if they persist.

DOSAGE & ADMINISTRATION SECTION

Directions: Adults and children 12 or more years of age.

Muscle Spasms - Take 1 or 2 tablets every 3 hours, until relief is obtained. To help prevent recurrence of muscle spasms, continue to take 1 or 2 tablets every 4 hours as needed.

Tension and Stress - Take 1 or 2 tablets every 4 hours, preferably with meals and at bedtime. To help prevent tension and stress take 1 or 2 tablets every 4 hours as needed.

Dosage should not exceed 12 tablets in any 24 hour period.

INACTIVE INGREDIENT SECTION

Lactose Monohydrate, Maltodextrin, Sodium Starch Glycolate Type A Potato, Stearic Acid, Silica

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of LabelImage of Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64175-991-252023-12-18C16284748780-1f386c649-ed36-0266-e053-dadaa90a7c1aRelax AM-PM
64175-991-452023-12-18C16284748780-1f386c649-ed36-0266-e053-dadaa90a7c1aRelax AM-PM
64175-991-902023-12-18C16284748780-1f386c649-ed36-0266-e053-dadaa90a7c1aRelax AM-PM
64175-991-252023-01-30C16284748780-1f386c649-ed36-0266-e053-dadaa90a7c1aRelax AM-PM
64175-991-452023-01-30C16284748780-1f386c649-ed36-0266-e053-dadaa90a7c1aRelax AM-PM
64175-991-902023-01-30C16284748780-1f386c649-ed36-0266-e053-dadaa90a7c1aRelax AM-PM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64175-991-25Relax AM-PM250 in 1 BOTTLETABLET2505
64175-991-45Relax AM-PM45 in 1 BOTTLETABLET455
64175-991-90Relax AM-PM90 in 1 BOTTLETABLET905

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64175-991RELAX AM-PM (VALERIAN ROOT, PASSIFLORA, MAGNESIUM CARBONATE) TABLET [FOSTER REGAL LABORATORIES]5Current NDC, Legacy NDC, 3 package rows20250108_ea434cd3-e4d5-44c1-a9cf-5d1a45280e90.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
MAGNESIUM CARBONATEACTIVE INGREDIENT0E53J927NA1
PASSIFLORA INCARNATA FLOWERACTIVE INGREDIENTK8F3G29S6Z1
ValerianACTIVE INGREDIENTJWF5YAW3QW1
MagnesiumACTIVE MOIETYI38ZP9992A1
PASSIFLORA INCARNATA FLOWERACTIVE MOIETYK8F3G29S6Z1
ValerianACTIVE MOIETYJWF5YAW3QW1
Lactose MonohydrateINACTIVE INGREDIENTEWQ57Q8I5X1
MaltodextrinINACTIVE INGREDIENT7CVR7L4A2D1
Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU41
Sodium Starch Glycolate Type A PotatoINACTIVE INGREDIENT5856J3G2A21
Stearic AcidINACTIVE INGREDIENT4ELV7Z65AP1

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
64175-99164175-991-90, 64175-991-45, 64175-991-25

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
MALTODEXTRIN7CVR7L4A2DIACT
SODIUM STARCH GLYCOLATE TYPE A POTATO5856J3G2A2IACT
STEARIC ACID4ELV7Z65APIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
VALERIANJWF5YAW3QWACTIB
PASSIFLORA INCARNATA FLOWERK8F3G29S6ZACTIB
MAGNESIUM CARBONATE0E53J927NAACTIB
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT

Source Document#

Source XML · Source PDF

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 · 16 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
Lactose MonohydrateLACTOSE MONOHYDRATEEWQ57Q8I5XTABLET / ORAL4384 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
Stearic AcidSTEARIC ACID4ELV7Z65APTABLET / ORAL336 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
MaltodextrinMALTODEXTRIN7CVR7L4A2DTABLET / ORAL320 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
MaltodextrinMALTODEXTRIN7CVR7L4A2DTABLET / ORAL320 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
Stearic AcidSTEARIC ACID4ELV7Z65APTABLET / ORAL336 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
Silicon DioxideSILICON DIOXIDEETJ7Z6XBU4TABLET / ORAL750 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
MaltodextrinMALTODEXTRIN7CVR7L4A2DTABLET / ORAL320 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
Silicon DioxideSILICON DIOXIDEETJ7Z6XBU4TABLET / ORAL750 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
Silicon DioxideSILICON DIOXIDEETJ7Z6XBU4TABLET / ORAL750 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
MaltodextrinMALTODEXTRIN7CVR7L4A2DTABLET / ORAL320 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
Stearic AcidSTEARIC ACID4ELV7Z65APTABLET / ORAL336 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
Lactose MonohydrateLACTOSE MONOHYDRATEEWQ57Q8I5XTABLET / ORAL4384 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
Silicon DioxideSILICON DIOXIDEETJ7Z6XBU4TABLET / ORAL750 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
Lactose MonohydrateLACTOSE MONOHYDRATEEWQ57Q8I5XTABLET / ORAL4384 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
Stearic AcidSTEARIC ACID4ELV7Z65APTABLET / ORAL336 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
Lactose MonohydrateLACTOSE MONOHYDRATEEWQ57Q8I5XTABLET / ORAL4384 mgExact identifier — unii+route+dosage form
4 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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Relax AM-PMVALERIAN ROOT, PASSIFLORA, MAGNESIUM CARBONATEFoster Regal Laboratoriesea434cd3-e4d5-44c1-a9cf-5d1a45280e902025-01-06WarningsExact identifier
ndc (package): 64175-991-25
ndc (package): 64175-991-45
ndc (package): 64175-991-90
ndc (product): 64175-991
ndc11 (package): 64175099125
ndc11 (package): 64175099145
ndc11 (package): 64175099190
spl id: 2b0c7469-816a-b341-e063-6294a90a2bcc
spl set id: ea434cd3-e4d5-44c1-a9cf-5d1a45280e90

Reported adverse events (FAERS/openFDA)#

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