Pms Relief
FDA Label NDC 47242-0051

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 Pms Relief (NDC 47242-0051). 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
Calcarea carbonica 30C, HPUSRelieves pain due to cramps
Kali-carbonica 30C, HPUSRelieves breast tenderness
Nux vomica 30C, HPUSRelieves irritability
Sepia 30C, HPUSRelieves irritability and cravings

"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: Analgesic.

Uses

For the relief of the painful symptoms of PMS, including pain, irritability and breast tenderness.

Warnings

  • Do not use if outer package seal is broken.
  • Stop use and consult a doctor if symptoms persist for more than 5 days, worsen, or are accompanied by fever.

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)

Chew two tablets thoroughly, allowing each to dissolve in the mouth, then swallow. Repeat every 4 hours as needed.

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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