Sprayology Sleepease
FDA Label NDC 61096-1001

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Eight And Company for the product Sprayology Sleepease (NDC 61096-1001). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, warnings, otc - keep out of reach of children, indications & usage, dosage & administration, other safety information, inactive ingredient, otc - purpose, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredient: Aquilegia vulgaris 2X, Avena sativa 2X, Chamomilla 2X, Coffea cruda 200C, Cypripedium pubescens 3X, Humulus lupulus 3X, Kali phosphoricum 12X, Passiflora incarnata 2X, Valeriana officinalis 2X, Zincum metallicum 12X.

Warnings

Warnings: If sleeplessness persists continuously for more than 2 weeks, consult your doctor. Insomnia may be a symptom of serious underlying medical illness. If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. Contains alcohol, in case of overdose, get medical help or contact a Poison Control Center right away.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Indications & Usage

Temporarily relieves the common symptoms of sleeplessness, including:

  • wakefulness
  • restlessness
  • emotional stress and anxiety
  • caffeine sensitivity

Dosage & Administration

Directions:

  • Adults and children over 12: 2 sprays into the mouth at bedtime and if sleep is interrupted.
  • Ages 2 to 12: 1 spray into the mouth at bedtime and if sleep is interrupted.
  • Under age 2: consult a health care professional.

Other Safety Information

Other Information: Do not use if the transparent seal around spray bottle is broken or missing.

Inactive Ingredient

Inactive Ingredients: Glycerin 10%, v/v, non-GMO organic alcohol 9% v/v and purified water.

Otc - Purpose

Temporarily relieves the common symptoms of sleeplessness, including:

° wakefulness

° restlessness

° emotional stress and anxiety

° caffeine sensitivity

° natural

° gluten free

° no artifical flavors or colors

° vegan

° no known negative side effects

° no known negative drug interactions

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