Sprayology Pms Support
FDA Label NDC 61096-0031

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 Pms Support (NDC 61096-0031). 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, dosage & administration, otc - purpose, other safety information, inactive ingredient, indications & usage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Otc - Active Ingredient

Active Ingredients: Apis mellifica 200C, Chamomilla 6X, Cimicifuga racemosa 6X, Cuprum metallicum 12X, Ignatia amara 6X, Kali iodatum 200C, Magnesia phosphorica 9X, Oophorinum 30C, Platinum metallicum 12X, Sepia 9X, Thuja occidentalis 200C.

Warnings

Warnings: If symptoms persist or worsen, stop use and seek advice of physician. 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.

Dosage & Administration

Directions:

  • Females over 12: 2 sprays into the mouth 3 times per day or as needed when experiencing symptoms.
  • Females who are under the age of 12: please consult a health care professional.

Otc - Purpose

Temporarily relieves common symptoms of pre-menstrual syndrome, including:

  • cramps
  • emotional fluctuations
  • fluid retention
  • irregular menstruation

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.

Indications & Usage

Temporarily relieves common symptoms of pre-menstrual syndrome, including:

° cramps

° emotional fluctuations

° fluid retention

° irregular menstruation

° natural

° gluten free

° no artificial flavors or colors

° no known negative drug interactions

* Please review the disclaimer below.