Simply Dreams

Manufacturer
Nartex Laboratorios Homeopaticos, S.A. De C.V.
Effective date
2021-12-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:15:13

Label at a glance#

ProductSimply Dreams
Active ingredientPASSIFLORA INCARNATA FLOWERING TOP, VALERIAN
Label structure9 sections

Indications and uses

Reduces time to fall asleep if you have difficulty falling asleep. For relief of occasional sleeplessness or intermittent awakening. Helps to reduce difficulty falling asleep. Claims based on traditional homeopathic practice, not accepted medical evidence. These uses have not been evaluated by FDA, and product has not been clinically tested.

Dosage and administration

adults and children 12 years and older: take 2 tablets every 24 hours. Dissolves slowly in mouth. children under 12 years, do not use.

Storage and handling

store in a cool and dry place. do not use if container seal is broken.

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Passiflora incarnata 1X HPUS*

Valeriana officinalis 1X HPUS*

Purpose

OTC - PURPOSE SECTION

Passiflora incarnata 1X HPUS*...................Sleeplessness from worries and restlessness

Valeriana officinalis 1X HPUS*....................Restless sleep

*The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States. "X" is a homeopathic dilution. See www.nartexlabsusa.com for more information.

Uses

INDICATIONS & USAGE SECTION

Reduces time to fall asleep if you have difficulty falling asleep. For relief of occasional sleeplessness or intermittent awakening. Helps to reduce difficulty falling asleep. Claims based on traditional homeopathic practice, not accepted medical evidence. These uses have not been evaluated by FDA, and product has not been clinically tested.

Warnings

WARNINGS SECTION

If sleeplessness persists continuously for more than 2 weeks, consult your doctor. Insomnia may be a symptom of serious underlying medical illness.

OTC - DO NOT USE SECTION

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.

OTC - STOP USE SECTION

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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast feeding, consult a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 12 years and older: take 2 tablets every 24 hours. Dissolves slowly in mouth.
  • children under 12 years, do not use.

Other information

STORAGE AND HANDLING SECTION

  • store in a cool and dry place.
  • do not use if container seal is broken.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Gelatin, Lactosa USP, Magnesium stearate, Potato starch, Purified water, Sodium benzoate, Talc USP

Questions or comments?

OTC - QUESTIONS SECTION

informacion@nartexlabs.com or call 1-877-248-1970 between 9am and 5pm CST. Active ingredients are prepared in accordance with the Homeopathic Pharmacopoeia of the United States, and are therefore non-toxic and have no known side effects.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 34666-402-01

SIMPLY Dreams

Nighttime Sleep Aid

  • Helps falling asleep naturally
  • No day-time grogginess
  • Calms restless sleep

Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated and not clinically tested.

Homeopathic

80 Tablets

11

22

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
34666-402-01Simply Dreams80 in 1 BOTTLETABLET801
34666-402-01Simply Dreams1 in 1 CARTONTABLET11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
34666-402SIMPLY DREAMS (PASSIFLORA INCARNATA, VALERIANA OFFICINALIS) TABLET [NARTEX LABORATORIOS HOMEOPATICOS, S.A. DE C.V.]1Current NDC, Legacy NDC, 2 package rows20211216_d2439b65-3875-c1a6-e053-2a95a90a40aa.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
34666-40234666-402-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 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
Simply DreamsPASSIFLORA INCARNATA, VALERIANA OFFICINALISNartex Laboratorios Homeopaticos, S.A. De C.V.d2439b65-3875-c1a6-e053-2a95a90a40aa2021-12-03WarningsExact identifier
ndc (package): 34666-402-01
ndc (product): 34666-402
ndc11 (package): 34666040201
spl id: d2439b65-3876-c1a6-e053-2a95a90a40aa
spl set id: d2439b65-3875-c1a6-e053-2a95a90a40aa

Reported adverse events (FAERS/openFDA)#

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