Sleepy Time Cp Liquid
FDA Label NDC 43406-0675

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Natural Creations, Inc for the product Sleepy Time Cp (NDC 43406-0675). 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, indications & usage, otc - purpose, dosage & administration, otc - keep out of reach of children, warnings, inactive ingredient, otc - questions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

ACTIVE INGREDIENTS (HPUS*) - equal amounts of: Aconitum 30X, Arsenicum Alb 30X, Calc Carb 30X, Coffea Cruda 30X, Magnesium Met 30X, Nux Vom 30X, Pulsatilla 30X, Sepia 30X, Sulphur 30X

Indications & Usage

USES: Temporarily relieves occasional sleeplessness.**

Otc - Purpose

USES: Temporarily relieves occasional sleeplessness.**

Dosage & Administration

DIRECTIONS: Adults & children above 12 years: 10 drops orally 3 times daily, or as directed by a health care professional.

Otc - Keep Out Of Reach Of Children

KEEP OUT OF THE REACH OF CHILDREN. In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center right away.

Warnings

WARNINGS:

  • IF PREGNANT OR BREAST-FEEDING, ask a health care professional before use.
  • KEEP OUT OF THE REACH OF CHILDREN. In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center right away.
  • Do not use if TAMPER EVIDENT seal is broken or missing.

Inactive Ingredient

INACTIVE INGREDIENTS: Citric Acid, Glycerin USP, Natural Cherry Flavor, Potassium Sorbate, Purified Water

Otc - Questions

QUESTIONS & COMMENTS?

Natural Creations, Inc. / Woodbine, IA 51579 / 712-647-1600

References

*The letters "HPUS" indicate the components in the product are officially monographed in the Homeopathic Pharmacopeia of the United States.

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Package Label.Principal Display Panel

NDC:43406-0675-1

Sleepy Time CP

HOMEOPATHIC

1 fl oz (30mL) / Alcohol Free

* Please review the disclaimer below.