Simply Dreams

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
Simply Dreams
Generic name
PASSIFLORA INCARNATA, VALERIANA OFFICINALIS
Manufacturer
Nartex Laboratorios Homeopaticos, S.A. De C.V.
Product type
HUMAN OTC DRUG
SPL set ID
d2439b65-3875-c1a6-e053-2a95a90a40aa
SPL ID
d2439b65-3876-c1a6-e053-2a95a90a40aa
Version
1
Effective date
2021-12-03
Source export date
2026-09-28
Source partition
13
Source file
https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/e78bf8aa9f90ab13e640d254dfbd4fe5bfeca4995ec5f9d51bce3356e249cab7/drug-label-0013-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:33:55
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 sleeplessness persists continuously for more than 2 weeks, consult your doctor. Insomnia may be a symptom of serious underlying medical illness. Do not use if you have an allergy or hypersensitivity to the components of the formula or have had a prior reaction to this product. for children under 12 years of age. Stop use and ask a doctor if condition worsens. symptoms persist for more than 7 days or clear up and occur again within a few days. rash develops. If pregnant or breast feeding, consult a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Reported adverse events (FAERS/openFDA)#

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