FDA.reportPublic FDA data

Calm Anxiety and Stress

Manufacturer
Pro Weight Loss Inc. | Apotheca Company
Effective date
2023-01-10
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:19:32

Label at a glance#

ProductCalm Anxiety and Stress
Active ingredientCLEMATIS VITALBA FLOWER, HELIANTHEMUM NUMMULARIUM FLOWER, IMPATIENS GLANDULIFERA FLOWER, ORNITHOGALUM UMBELLATUM FLOWERING TOP, PASSIFLORA INCARNATA FLOWERING TOP, ANGELICA SINENSIS ROOT, SILVER NITRATE, COCOA, LITHIUM CARBONATE, PRUNUS CERASIFERA FLOWER, VALERIAN, MACROPIPER METHYSTICUM ROOT, SUS SCROFA ADRENAL GLAND, ACONITUM NAPELLUS WHOLE, SEMECARPUS ANACARDIUM JUICE, ARSENIC TRIOXIDE, OYSTER SHELL CALCIUM CARBONATE, CRUDE, ANAMIRTA COCCULUS SEED, STRYCHNOS IGNATII SEED, GELSEMIUM SEMPERVIRENS ROOT
Label structure9 sections

Dosage and administration

1-10 drops under the tongue, 3 times a day or as directed by your health professional. Consult a physician for use in children under 12 years of age.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

Clematis Vitalba, Flos 3X, Helianthemum Nummularium, Flos 3X, Impatiens Glandulifera, Flos 3X, Ornithogalum Umbellatum, Flos 3X, Passiflora Incarnata 3X, Angelica Sinensis 6X, Argentum Nitricum 6X, Cacao 6X, Lithium Carbonicum 6X, Prunus Cerasifera, Flos 6X, Valeriana Officinalis 6X, Piper Methysticum 7X, Glandula Suprarenalis Suis 8X, Aconitum Napellus 12X, Anacardium Orientale 12X, Arsenicum Album 12X, Calcarea Carbonica 12X, Cocculus Indicus 12X, Ignatia Amara 12X, Gelsemium Sempervirens 12X, 30X.

HOMEOPATHIC INDICATIONS:

OTC - PURPOSE SECTION

For temporary relief of symptoms related to stress including mild anxiousness, worry, overwhelm, and mild fear.**

**These statements are based upon traditional homeopathic principles. They have not been reviewed by the Food and Drug Administration.

WARNINGS:

WARNINGS SECTION

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

If pregnant or breast-feeding, ask a healthcare professional before use.

Tamper seal: sealed for your protection.

Do not use if seal is broken or missing.

KEEP OUT OF REACH OF CHILDREN:

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.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

1-10 drops under the tongue, 3 times a day or as directed by your health professional. Consult a physician for use in children under 12 years of age.

HOMEOPATHIC INDICATIONS:

INDICATIONS & USAGE SECTION

For temporary relief of symptoms related to stress including mild anxiousness, worry, overwhelm, and mild fear.**

**These statements are based upon traditional homeopathic principles. They have not been reviewed by the Food and Drug Administration.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

demineralized water, 25% ethanol

QUESTIONS:

OTC - QUESTIONS SECTION

Distributed by

Pro Weight Loss Inc., 94 Boylston Cir.

Shrewsbury, MA 01545 • 877-323-0107

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70558-0010-1
Pro Weight Loss
HOMEOPATHIC
Calm 

Anxiety and Stress

1 FL OZ (30 ml)

Calm Anxiety and StressCalm Anxiety and Stress

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b3053bb1-353b-4a0b-bca5-28fe7228957cProduct name220250124
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506
8ce6e144-236f-b7be-f690-f06e0c8c6bd3Product name220170725
f09af6ee-c6dd-d0ce-77ad-93508bcdacedProduct name420161205
6cca4355-1206-91f7-02de-17eef38a8622Product name120140508
751c581a-bf64-2fd7-b3ec-ca02c83e4a00Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70558-0010-1Calm Anxiety and Stress30 mL in 1 BOTTLE, DROPPERLIQUID302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70558-0010CALM ANXIETY AND STRESS (CLEMATIS VITALBA, FLOS, HELIANTHEMUM NUMMULARIUM, FLOS, IMPATIENS GLANDULIFERA, FLOS, ORNITHOGALUM UMBELLATUM, FLOS, PASSIFLORA INCARNATA, ANGELICA SINENSIS, ARGENTUM NITRICUM, CACAO, LITHIUM CARBONICUM, PRUNUS CERASIFERA, FLOS, VALERIANA OFFICINALIS, PIPER METHYSTICUM, GLANDULA SUPRARENALIS SUIS, ACONITUM NAPELLUS, ANACARDIUM ORIENTALE, ARSENICUM ALBUM, CALCAREA CARBONICA, COCCULUS INDICUS, IGNATIA AMARA, GELSEMIUM SEMPERVIRENS) LIQUID [PRO WEIGHT LOSS INC.]2Current NDC, Legacy NDC, 1 package rows20230111_f5fb248f-e078-4dba-9bee-be0e803b6a13.zip

Products#

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

DailyMed product names page 1 of 1 · 28 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70558-001070558-0010-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
CLEMATIS VITALBA FLOWER7SCP4N87CIACTIB
HELIANTHEMUM NUMMULARIUM FLOWER51BRR32WPPACTIB
IMPATIENS GLANDULIFERA FLOWERAJU5O1A5ZVACTIB
ORNITHOGALUM UMBELLATUM FLOWERING TOPCZD6M4PY4BACTIB
PASSIFLORA INCARNATA FLOWERING TOPCLF5YFS11OACTIB
ANGELICA SINENSIS ROOTB66F4574UGACTIB
SILVER NITRATE95IT3W8JZEACTIB
COCOAD9108TZ9KGACTIB
LITHIUM CARBONATE2BMD2GNA4VACTIB
PRUNUS CERASIFERA FLOWER0KD7R09EASACTIB
VALERIANJWF5YAW3QWACTIB
MACROPIPER METHYSTICUM ROOTBOW48C81XPACTIB
SUS SCROFA ADRENAL GLAND398IYQ16YVACTIB
ACONITUM NAPELLUS WHOLEU0NQ8555JDACTIB
SEMECARPUS ANACARDIUM JUICEY0F0BU8RDUACTIB
ARSENIC TRIOXIDES7V92P67HOACTIB
OYSTER SHELL CALCIUM CARBONATE, CRUDE2E32821G6IACTIB
ANAMIRTA COCCULUS SEED810258W28UACTIB
STRYCHNOS IGNATII SEED1NM3M2487KACTIB
GELSEMIUM SEMPERVIRENS ROOT639KR60Q1QACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT

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
Calm Anxiety and StressCLEMATIS VITALBA, FLOS, HELIANTHEMUM NUMMULARIUM, FLOS, IMPATIENS GLANDULIFERA, FLOS, ORNITHOGALUM UMBELLATUM, FLOS, PASSIFLORA INCARNATA, ANGELICA SINENSIS, ARGENTUM NITRICUM, CACAO, LITHIUM CARBONICUM, PRUNUS CERASIFERA, FLOS, VALERIANA OFFICINALIS, PIPER METHYSTICUM, GLANDULA SUPRARENALIS SUIS, ACONITUM NAPELLUS, ANACARDIUM ORIENTALE, ARSENICUM ALBUM, CALCAREA CARBONICA, COCCULUS INDICUS, IGNATIA AMARA, GELSEMIUM SEMPERVIRENSPro Weight Loss Inc.f5fb248f-e078-4dba-9bee-be0e803b6a132023-01-10WarningsExact identifier
ndc (package): 70558-0010-1
ndc (product): 70558-0010
ndc11 (package): 70558001001
spl id: 706ae87e-d4ae-4132-a930-23598e0fa7fe
spl set id: f5fb248f-e078-4dba-9bee-be0e803b6a13

Reported adverse events (FAERS/openFDA)#

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