The following Structured Product Label (SPL) was submitted to the FDA by Liddell Laboratories, Inc. for the product Problen Estrogen And Progesterone (NDC 50845-0138). 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, otc - purpose, warnings, dosage & administration, inactive ingredient, otc - keep out of reach of children, indications & usage, otc - questions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
ACTIVE INGREDIENTS: Agnus castus 3X, Angelica sinensis, radix 3X, Apis mellifica 6X, Arnica montana 6X, Cimicifuga racemosa 3X, Estradiol 9C, Estriol 9C, Folliculinum 9C, Galium aparine 3X, Glycyrrhiza glabra 3X, Korean ginseng 3X, Oophorinum bovinum 30C, Progesterone 6X, Sepia 30C, Thuja occidentalis 6X, Viscum album 3X.
INDICATIONS: Temporarily supports the body to rebalance estrogen output. Symptoms may include: mood swings, hot flashes, irritability, lack of energy.
WARNINGS: Not for use on children. If symptoms continue to recur, or if sleeplessness persists continuously for more than two weeks, consult a physician. Insomnia may be a symptom of a serious underlying medical illness.
As with all medicines, if you are pregnant or breast feeding, consult a health professional before using this product.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
TAMPER EVIDENT: There is a seal around the neck of the bottle. Do not use if this seal is broken or missing.
DIRECTIONS: Adults: Hold the spray-top close to your open mouth and spray twice directly under your tongue, three times a day. Some people notice improvement within two or three weeks, others take longer.
INACTIVE INGREDIENTS: Organic alcohol 30% v/v, Purified water.
KEEP OUT OF REACH OF CHILDREN. In case of overdose, get medical help or contact a Poison Control Center right away.
INDICATIONS: Temporarily supports the body to rebalance estrogen output. Symptoms may include: mood swings, hot flashes, irritability, lack of energy.
Distributed by ProBLEN
(888) 326-2121
www.problen.com
2850 Shoreline Trail
Rockwall, TX 75032
Estrogen and Progesterone
HOMEOPATHIC
ORGANOTHERAPY
1.0 FL OZ (30 ML)
Estrogen And Progesterone (Mm1)
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