FDA.reportPublic FDA data

PMS

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name
PMS
Generic name
ANGELICA ARCHANGELICA, CIMICIFUGA RACEMOSA, FUCUS VESICULOSUS, HYPOTHALAMUS SUIS, MAGNESIUM GLUCONICUM DIHYDRICUM, OOPHORINUM (SUIS) PYRIDOXINUM HYDROCHLORICUM, BOVISTA, CUPRUM METALLICUM, SEPIA, ZINCUM METALLICUM, LACHESIS MUTUS
Manufacturer
BioActive Nutritional, Inc.
Product type
HUMAN OTC DRUG
SPL set ID
85304d4f-78b9-499e-8e1d-9202d9cde33d
SPL ID
a95c2a6d-b962-43bd-84b0-d9f8812364f4
Version
5
Effective date
2025-04-02
Source export date
2026-10-12
Source partition
8
Source file
https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/fa098e7c5cff0b1ab653ce934059d1f4b90b860bafc0383a1f66223ce1037518/drug-label-0008-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:14:50
Harmonized routes table
Harmonized routes
ORAL

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

WARNINGS: If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Do not use if tamper evident seal is broken or missing. Store in a cool, dry place.

Reported adverse events (FAERS/openFDA)#

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