Simply Dreams

Simply Dreams
SPL v1
SPL
SPL Set ID d2439b65-3875-c1a6-e053-2a95a90a40aa
Route
ORAL
Published
Effective Date 2021-12-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Passiflora Incarnata Flowering Top (1 [hp_X]) Valerian
Inactive Ingredients
Sodium Benzoate Gelatin Starch, Potato Talc Magnesium Stearate Water Lactose, Unspecified Form

Identifiers & Packaging

Pill Appearance
Imprint: LogoNartex Shape: round Color: white Size: 9 mm
Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2021-12-03

Description

Passiflora incarnata 1X HPUS* Valeriana officinalis 1X HPUS*

Purpose

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.


Medication Information

Purpose

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.

Description

Passiflora incarnata 1X HPUS* Valeriana officinalis 1X HPUS*

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.

Section 50565-1

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

Section 50566-9

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.
Section 50570-1

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.
Section 51945-4

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

Section 53414-9

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

Warnings

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

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

Passiflora incarnata 1X HPUS*

Valeriana officinalis 1X HPUS*

Inactive Ingredients

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

Questions Or Comments?

[email protected] 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.


Structured Label Content

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.

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

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.
Section 50570-1 (50570-1)

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.
Section 51945-4 (51945-4)

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

Section 53414-9 (53414-9)

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

Purpose

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.

Warnings

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

Directions
  • 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 (Other information)
  • store in a cool and dry place.
  • do not use if container seal is broken.
Active Ingredients (Active ingredients)

Passiflora incarnata 1X HPUS*

Valeriana officinalis 1X HPUS*

Inactive Ingredients (Inactive ingredients)

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

Questions Or Comments? (Questions or comments?)

[email protected] 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.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)