FDA.reportPublic FDA data

STRAMONIUM

Manufacturer
Standard Homeopathic Company
Effective date
2021-12-06
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:24:39

Label at a glance#

ProductSTRAMONIUM
Active ingredientDATURA STRAMONIUM
Label structure9 sections

Label contents#

Full prescribing information#

OTC - PURPOSE SECTION

PURPOSE RESTLESSNESS OR SUN HEADACHE

INDICATIONS & USAGE SECTION

INDICATIONS RESTLESSNESS OR SUN HEADACHE

WARNINGS SECTION

WARNINGS Do not use if cap band is missing or broken. If you are pregnant or nursing, consult a licensed health care professional before using this product. If symptoms persist for 7 days or worsen, contact a licensed practitioner. To be used according to label indications and/or standard homeopathic indications.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN Keep this and all medicines out of the reach of children.

DOSAGE & ADMINISTRATION SECTION

DIRECTIONS: ADULTS: Dissolve 4 tablets under tongue 4 times a day. CHILDREN: 2 tablets as above.

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENT In a base of Acacia Gum and Lactose N.F.

OTC - QUESTIONS SECTION

QUESTIONS 800-624-9659

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENT STRAMONIUM 6X

PRINCIPAL DISPLAY PANEL - 250 TABLET LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Standard Homeopathic

Made in the USA Since 1903

NDC # 0360-0362-01

Homeopathic Medicine

STRAMONIUM

6X

RESTLESSNESS OR SUN HEADACHE

250 TABLETS

LabelLabel

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0360-03620360-0362-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
DATURA STRAMONIUMG6W4F0V8Z3ACTIB
ACACIA5C5403N26OIACT
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT

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
d27f93d3-6a35-2234-e053-2995a90a36b85cf01bed-da68-f046-e053-2a91aa0a21752021-12-06WarningsExact identifier
spl id: d27f93d3-6a35-2234-e053-2995a90a36b8
spl set id: 5cf01bed-da68-f046-e053-2a91aa0a2175

Reported adverse events (FAERS/openFDA)#

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