FDA.reportPublic FDA data

Stress Less

Manufacturer
Stress Less, Inc. | Newton Laboratories, Inc.
Effective date
2018-01-10
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:09:09

Label at a glance#

ProductStress Less
Active ingredientACONITUM NAPELLUS, AMBERGRIS, SEMECARPUS ANACARDIUM JUICE, SILVER NITRATE, ASAFETIDA, BRYONIA ALBA ROOT, MATRICARIA RECUTITA, BLACK COHOSH, ARABICA COFFEE BEAN, CYPRIPEDIUM PARVIFOLUM ROOT, GELSEMIUM SEMPERVIRENS ROOT, HYOSCYAMUS NIGER, HYPERICUM PERFORATUM, STRYCHNOS IGNATII SEED, POTASSIUM PHOSPHATE, DIBASIC, STRYCHNOS NUX-VOMICA SEED, SAMBUCUS NIGRA FLOWERING TOP, STRYCHNINE, THERIDION CURASSAVICUM, VALERIAN, PASSIFLORA INCARNATA FLOWERING TOP
Label structure10 sections

Label contents#

Full prescribing information#

QUESTIONS SECTION

OTC - QUESTIONS SECTION

Manuractured for Stress Less, Inc., Atlanta, GA 30319

​Questions? 800-555-3783

INDICATIONS & USAGE SECTION

Stress Less: Formulated for associated symptoms such as nervous discomfort, irritability, racing thoughts, restlessness, tension and worry.

DOSAGE & ADMINISTRATION SECTION

Directions: Ages 12 and up, take 6 drops by mouth (ages 0 to 11, give 3 drops) as needed or as directed by a health professional. Sensitive persons begin with 1 drop and gradually increase to full dose.

OTC - ACTIVE INGREDIENT SECTION

Equal parts of Passiflora 3x, Valeriana 3x Aconitum nap. 15x, Ambra 15x, Anacard. or. 15x, Arg. nit. 15x, Asafoetida 15x, Bryonia 15x, Chamomilla 15x, Cimicifuga 15x, Coffea cruda 15x, Cypripedium 15x, Gelsemium 15x, Hyoscyamus 15x, Hypericum 15x, Ignatia 15x, Kali phos. 15x, Nux vom. 15x, Sambucus nig. 15x, Strychninum 15x, Theridion 15x, Valeriana 15x, .

OTC - PURPOSE SECTION

Formulated for associated symptoms such as nervous discomfort, irritability, racing thoughts, restlessness, tension and worry.

INACTIVE INGREDIENT SECTION

Inactive Ingredients: USP Purified Water; USP Gluten-free, non-GMO, organic cane alcohol 20%.

WARNINGS SECTION

Warning: Keep ou of reach of children. Do not use ​if tamper-evident seal is broken or missing. If symptoms worsen or persist for more than a few days, consult a doctor. If ​pregnant or breast-feeding,​ ask a doctor before use.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If ​pregnant or breast-feeding,​ ask a doctor before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

PACKAGE LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

package labelpackage label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
4b7700e3-6e0e-45e5-9d22-6f754d61386eProduct name220250304
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
6cca4355-1206-91f7-02de-17eef38a8622Product name120140508
751c581a-bf64-2fd7-b3ec-ca02c83e4a00Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67840-0001-12020-01-31C16284748780-19d75b9d0-1789-f424-e053-dadaa90a57ceStress Less

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67840-0001-1Stress Less30 mL in 1 BOTTLE, GLASSLIQUID301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67840-0001STRESS LESS (ACONITUM NAP., AMBRA, ANACARDIUM ORIENTALE, ARG. NIT., ASAFOETIDA, BRYONIA, CHAMOMILLA, CIMICIFUGA, COFFEA CRUDA, CYPRIPEDIUM, GELSEMIUM, HYOSCYAMUS, HYPERICUM, IGNATIA, KALI PHOS., NUX VOM., SAMBUCUS NIG., STRYCHNINUM, THERIDION, VALERIANA, PASSIFLORA) LIQUID [STRESS LESS, INC.]1Legacy NDC, 1 package rows20180115_626f6019-93f2-6818-e053-2991aa0a33f0.zip

Products#

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

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67840-000167840-0001-1

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
ALCOHOL3K9958V90MIACT
ACONITUM NAPELLUSU0NQ8555JDACTIB
AMBERGRISXTC0D02P6CACTIB
SEMECARPUS ANACARDIUM JUICEY0F0BU8RDUACTIB
SILVER NITRATE95IT3W8JZEACTIB
ASAFETIDAW9FZA51AS1ACTIB
BRYONIA ALBA ROOTT7J046YI2BACTIB
MATRICARIA RECUTITAG0R4UBI2ZZACTIB
BLACK COHOSHK73E24S6X9ACTIB
ARABICA COFFEE BEAN3SW678MX72ACTIB
CYPRIPEDIUM PARVIFOLUM ROOT21Y9GZ1LZAACTIB
GELSEMIUM SEMPERVIRENS ROOT639KR60Q1QACTIB
HYOSCYAMUS NIGER4WRK2153H3ACTIB
HYPERICUM PERFORATUMXK4IUX8MNBACTIB
STRYCHNOS IGNATII SEED1NM3M2487KACTIB
POTASSIUM PHOSPHATE, DIBASICCI71S98N1ZACTIB
STRYCHNOS NUX-VOMICA SEED269XH13919ACTIB
SAMBUCUS NIGRA FLOWERING TOPCT03BSA18UACTIB
STRYCHNINEH9Y79VD43JACTIB
THERIDION CURASSAVICUM9Z8D3HEM8LACTIB
VALERIANJWF5YAW3QWACTIB
PASSIFLORA INCARNATA FLOWERING TOPCLF5YFS11OACTIB

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
626f4e66-a9ad-3769-e053-2a91aa0a7116626f6019-93f2-6818-e053-2991aa0a33f02018-01-10WarningsExact identifier
spl id: 626f4e66-a9ad-3769-e053-2a91aa0a7116
spl set id: 626f6019-93f2-6818-e053-2991aa0a33f0

Reported adverse events (FAERS/openFDA)#

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