Active Ingredients:
Progesterone 6X, 12X, 30X, 12C, 30C.
Progesterone Phenolic Liquid
FDA Label NDC 44911-0047
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Energique, Inc. for the product Progesterone Phenolic (NDC 44911-0047). 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 active ingredients:, indications:, warnings:, directions:, inactive ingredients:, keep out of reach of children:, questions:, package label display:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Indications:
May temporarily relieve symptoms associated with reactions to progesterone such as mood swings, painful menses, breast tenderness, headaches, hot flashes, and nervousness.**
**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
May temporarily relieve symptoms associated with reactions to progesterone such as mood swings, painful menses, breast tenderness, headaches, hot flashes, and nervousness.**
**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
Warnings:
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Do not use if tamper evident seal is broken or missing. Store in a cool, dry place.
Directions:
Adults and children 5 to 10 drops orally, 1 time daily or as otherwise directed by a health care professional. If symptoms persist, consult your health care professional. Consult a physician for use in children under 12 years of age.
Inactive Ingredients:
Demineralized water, 20% Ethanol.
Keep Out Of Reach Of Children:
If pregnant or breast-feeding, In case of overdose, get medical help or contact a Poison Control Center right away.
Questions:
Dist. by Energique, Inc. 201 Apple Blvd.
Woodbine, IA 51579 800-869-8078
Package Label Display:
ENERGIQUE
SINCE 1987
HOMEOPATHIC REMEDY
PROGESTERONE
PHENOLIC
1 fl. oz. (30 ml)
* Please review the disclaimer below.
