Sleep Relief
FDA Label NDC 47242-0061

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Homeostasis Laboratories, Inc. for the product Sleep Relief (NDC 47242-0061). 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, uses, warnings, otc - pregnancy or breast feeding, otc - keep out of reach of children, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active IngredientsPurpose
Arsenicum album 30C, HPUSRelieves anxiety and restlessness
Coffea cruda 30C, HPUSRelaxes the mind
Nitricum acidum 30C, HPUSRelieves frequent waking
Rhus toxicodendron 30C, HPUSRelieves restlessness
Selenium 30C, HPUSRelieves light sleeping
Zincum metallicum 30C, HPUSRelieves restlessness

"HPUS" indicates that the ingredient is officially included in the Homeopathic Pharmacopeia of the United States and the manufacturer has followed all guidelines set forth.

Statement of Identity: Nighttime sleep aid.

Uses

For the relief of sleeplessness and to reduce the difficulty of falling asleep.

Warnings

  • Do not use if outer package seal is broken.
  • If sleeplessness persists for more than 2 weeks or worsens, consult a doctor. Insomnia may be a symptom of a serious underlying illness.
  • Do not give to children under 12 years of age.

Otc - Pregnancy Or Breast Feeding

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

Otc - Keep Out Of Reach Of Children

  • Keep out of reach of children.

Directions

(adults and children 12 years of age and older)

Before bedtime chew two tablets thoroughly, allowing each to dissolve in the mouth, then swallow.

Other Information

  • Safe to take with all other medications.
  • Store at 68-77°F (20-25°C) and keep out of direct sunlight.
  • Avoid humid or damp storage conditions. Close well when not in use.

Inactive Ingredients

Lactose, magnesium stearate (vegetable source), stevia leaf extract.

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