FDA.reportPublic FDA data

Calm Plus

Manufacturer
MediNatura Inc
Effective date
2022-08-18
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:55:14

Label at a glance#

ProductCalm Plus
Active ingredientAVENA SATIVA FLOWERING TOP, MATRICARIA RECUTITA, PASSIFLORA INCARNATA FLOWERING TOP, TRIBASIC CALCIUM PHOSPHATE, DIBASIC POTASSIUM PHOSPHATE, POTASSIUM SULFATE, MAGNESIUM PHOSPHATE, DIBASIC, SODIUM CHLORIDE, SODIUM SULFATE, ZINC VALERATE DIHYDRATE, ARABICA COFFEE BEAN, STRYCHNOS NUX-VOMICA SEED, SULFUR
Label structure8 sections

Indications and uses

For the temporary relief of: • Simple nervous tension • Restlessness • Trouble sleeping

Dosage and administration

Dosage: Adults 18 and over: 1 tablet sublingually or dissolved completely in mouth 2 to 3 times per day or as directed by a physician.

Label contents#

Full prescribing information#

WARNINGS

WARNINGS SECTION

WARNINGS: If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children.

If symptoms persist or worsen, or if sleeplessness persists continuously for more than 2 weeks, consult your doctor.

Insomnia may be a symptom of serious underlying medical illness.

Do not use if sensitivity to Calm Plus or any of its ingredients exists. In case of accidental overdose, contact a Poison Control Center immediately.

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN

USES

INDICATIONS & USAGE SECTION

For the temporary relief of:

• Simple nervous tension

• Restlessness

• Trouble sleeping

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients:

Each tablet contains equal parts of Avena sativa 2X; Chamomilla 2X; Humulus lupulus 2X; Passiflora incarnata 2X; Calcarea phosphorica 6X; Kali phosphoricum 6X; Kali sulphuricum 6X; Magnesia phosphorica 6X; Natrum muriaticum 6X; Natrum sulphuricum 6X; Zincum valerianicum 6X; Coffea cruda 12X; Nux vomica 12X; Sulphur 12X

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Inactive Ingredients:

Lactose, Magnesium stearate

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Dosage: Adults 18 and over: 1 tablet sublingually or dissolved completely in mouth 2 to 3 times per day or as directed by a physician.

PURPOSE

OTC - PURPOSE SECTION

For the temporary relief of:

• Simple nervous tension

• Restlessness

• Trouble sleeping

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Dr. Hendel Calm PlusDr. Hendel Calm Plus

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DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62795-1115CALM PLUS (AVENA SATIVA FLOWERING TOP, MATRICARIA RECUTITA, PASSIFLORA INCARNATA FLOWERING, TRIBASIC CALCIUM PHOSPHATE, DIBASIC POTASSIUM PHOSPHATE, POTASSIUM SULFATE, MAGNESIUM PHOSPHATE, DIBASIC, SODIUM CHLORIDE, SODIUM SULFATE, ZINC VALERATE DIHYDRATE, ARABICA COFFEE BEAN, STRYCHNOS NUX-VOMICA SEED, AND SULFUR) TABLET [MEDINATURA INC]3Legacy NDC20220820_23b540c5-ed00-4858-b23e-33537969a03e.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62795-1115-2EA - Each62795-1115d8324841-0901-477c-bf7e-2381e304744b12017-04-05

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62795-111562795-1115-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
AVENA SATIVA FLOWERING TOPMA9CQJ3F7FACTIB
MATRICARIA RECUTITAG0R4UBI2ZZACTIB
PASSIFLORA INCARNATA FLOWERING TOPCLF5YFS11OACTIB
TRIBASIC CALCIUM PHOSPHATE91D9GV0Z28ACTIM
DIBASIC POTASSIUM PHOSPHATECI71S98N1ZACTIB
POTASSIUM SULFATE1K573LC5TVACTIB
MAGNESIUM PHOSPHATE, DIBASICA1Y870209ZACTIB
SODIUM CHLORIDE451W47IQ8XACTIB
SODIUM SULFATE0YPR65R21JACTIB
ZINC VALERATE DIHYDRATEMN0RX54EQAACTIB
ARABICA COFFEE BEAN3SW678MX72ACTIB
STRYCHNOS NUX-VOMICA SEED269XH13919ACTIB
SULFUR70FD1KFU70ACTIB
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
MAGNESIUM STEARATE70097M6I30IACT

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
c0eeb7b9-388c-410e-a8d0-00e2860b16e023b540c5-ed00-4858-b23e-33537969a03e2022-08-18WarningsExact identifier
spl id: c0eeb7b9-388c-410e-a8d0-00e2860b16e0
spl set id: 23b540c5-ed00-4858-b23e-33537969a03e

Reported adverse events (FAERS/openFDA)#

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