Serenity Remedy No. 12
FDA Label NDC 55926-0012

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Speer Laboratories, Llc for the product Serenity Remedy No. 12 (NDC 55926-0012). 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, inactive ingredient, indications & usage, dosage & administration, otc - keep out of reach of children, warnings, other safety information, 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 HPUS:  Aconitum napellus, Apis mellifica, Arnica montana, Arsenicum album, Belladonna, Bellis perennis, Bryonia, Calendula officinalis, Chamomilla, Clematis erecta, Clematis vitalba, flos, Ferrum phosphoricum, Histaminum hydrochloricum, Hypericum perforatum, Ignatia amara, Impatiens glandulifera, flos, ornithogalum umbellatum, flos, Passiflora incarnata, Phosphorus, Prunus cerasifera, flos, Rhus toxicodendron, sulphur, symphytum officinale, Veratrum album.

Equal volumes of each ingredient in: 10X, 30X, LM1 potencies.

HPUS indicates that this ingredient is officially part of the Homeopathic Pharmacopia of the United States.

Inactive Ingredient

Inactive Ingredients: Citric acid, Potassium sorbate, Purified water.

Indications & Usage

Uses: Temporarily relieves symptoms of:

  • mental, physical or emotional stress
  • tension
  • apathy
  • oversensitivity
  • body pains
  • nervousness
  • irritability
  • fearfulness
  • sleepessness

Dosage & Administration

Directions: Hold close to mouth and spray directly into mouth. Use 3 times daily. Use additionally as needed. Adult Dose: 3 pump sprays. Children 2-12 years: 2 pump sprays.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Warnings

Warnings:

Stop use and ask a doctor if symptoms persist, worsen or if new symptoms occur. If pregnant or breastfeeding, consult a doctor before use.

Other Safety Information

Other Information: Tamper resistant for your protection. Use only if safety seal is still intact.

Otc - Purpose

Uses: Temporarily relieves symptoms of: mental, physical or emotional stress, tension, apathy, oversensitivity, body pains, nervousness, irritability, fearfulness, sleepessness

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Image Description (Serenity)

Image Description (Serenity)

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