StressCalm

Manufacturer
Boiron | Boiron, Inc.
Effective date
2023-04-05
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:20:45

Label at a glance#

ProductStressCalm
Active ingredientACONITUM NAPELLUS, ATROPA BELLADONNA, CHELIDONIUM MAJUS, CALENDULA OFFICINALIS FLOWERING TOP, ABRUS PRECATORIUS SEED, VIBURNUM OPULUS BARK
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients** (in each pellet)

Aconitum napellus 6C HPUS (0.07 mg) (contains less than 10 -15 mg aconitine alkaloids)

Belladonna 6C HPUS (0.07 mg) (contains less than 10 -15 mg atropine alkaloids)

Calendula officinalis 6C HPUS (0.07 mg)

Chelidonium majus 6C HPUS (0.07 mg) (contains less than 10 -15 mg chelidonine alkaliods)

Jequirity 6C HPUS (0.07 mg) (contains less than 10 -14 indole alkaloids)

Viburnum opulus 6C HPUS (0.07 mg)

The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

OTC - PURPOSE SECTION

Purpose*

Relieves Occasional Stress Symptoms: Nervous Tension, Irritability, Fatigue, and Uneasiness

INDICATIONS & USAGE SECTION

Uses*

Temporarily relieves symptoms of occasional stress such as:

nervous tension

fatigue

digestive symptoms caused by stress

hypersensitivity to stress or noise

irritability

uneasiness

does not affect alertness

OTC - STOP USE SECTION

Stop use and ask a doctor if symptoms persist continuously for more than 2 weeks or worsen.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breastfeeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 12 years of age and older: Dissolve 5 pellets under the tongue 3 times a day until symptoms are relieved.
  • Children under 12 years of age: Ask a doctor.

INACTIVE INGREDIENT SECTION

lactose, sucrose

SPL UNCLASSIFIED SECTION

do not use if glued carton end flaps are open or if pellet dispenser seal is broken

contains 0.25 g of sugar per dose

Multi-Symptom

Stress Relief*

Plant-powered Relief

Meltaway Pellets

2 PORTABLE TUBES

APPROX. 80 PELLETS EACH

TOTAL 160 PELLETS

Tube - Contains approx. 80 pellets, 3.8 g (0.13 oz)

Turn tube upside down

Twist until 5 pellets are dispensed

Remove cap and pour pellets under the tongue

Do not use if pellet dispenser seal is broken.

*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.
**C,K,CK, and X are homeopathic dilutions: see BoironUSA.com/info for details.

OTC - QUESTIONS SECTION

BoironUSA.com

Info@Boiron.com

1-800-264-7661

Made in France

Disbributed by

Boiron, Inc.

Newtown Square, PA

19073

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabellabellabel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0220-9334-41StressCalm80 in 1 TUBEPELLET802
0220-9334-42StressCalm2 in 1 BOXPELLET22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0220-9334STRESSCALM (ACONITUM NAPELLUS, ATROPA BELLADONNA, CHELIDONIUM MAJUS, CALENDULA OFFICINALIS FLOWERING TOP, VIBURNUM OPULUS BARK, ABRUS PRECATORIUS SEED) PELLET [BOIRON]2Current NDC, Legacy NDC, 2 package rows20230406_ddcbbaae-ca20-9e18-e053-2a95a90a267f.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0220-93340220-9334-41, 0220-9334-42

Ingredients#

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

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

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
StressCalmACONITUM NAPELLUS, ATROPA BELLADONNA, CHELIDONIUM MAJUS, CALENDULA OFFICINALIS FLOWERING TOP, VIBURNUM OPULUS BARK, ABRUS PRECATORIUS SEEDBoironddcbbaae-ca20-9e18-e053-2a95a90a267f2023-04-05Exact identifier
ndc (package): 0220-9334-42
ndc (package): 0220-9334-41
ndc (product): 0220-9334
ndc11 (package): 00220933441
ndc11 (package): 00220933442
spl id: f89758d3-9391-56cc-e053-6394a90a94c6
spl set id: ddcbbaae-ca20-9e18-e053-2a95a90a267f

Reported adverse events (FAERS/openFDA)#

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