Dysfunctional Bleeding Drops Liquid
FDA Label NDC 63083-2138

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Professional Complementary Health Formulas for the product Dysfunctional Bleeding Drops (NDC 63083-2138). 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, questions, indications, otc - purpose, warnings, otc - keep out of reach of children, otc - pregnancy or breast feeding, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Hypothalamus 6X
Liver 6X
Ovary 6X
Pituitary 6X
Spleen 6X
Uterus 6X
Agnus castus 8X
Coffea tosta 8X
Calendula officinalis 9X
Hydrastis canadensis 9X
Capsella bursa-pastoris 12X
Endometritis tuberculosa 12X
Helonias luteum 12X
Silicea 12X
Trifolium pratense 12X
Viburnum opulus 12X
Apis mellifica 30X
Cactus grandiflorus 30X
Collinsonia canadensis 30X
Gelsemium sempervirens 30X
Nux vomica 30X
Veratrum album 30X

Questions

Professional Formulas

PO Box 2034 Lake Oswego, OR 97035

Indications

For the temporary relief of occasional mild spotting or menstrual irregularity.*

Otc - Purpose

*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Warnings

Any significant vaginal bleeding or change in menstrual pattern requires evaluation by a doctor. Keep out of the reach of children. In case of overdose, get medical help or contact a poison control center right away. If pregnant or breastfeeding, ask a healthcare professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of the reach of children.

Otc - Pregnancy Or Breast Feeding

If pregnant or breastfeeding, ask a healthcare professional before use.

Directions

Place drops under tongue 30 minutes before/after meals. Adults and children 12 years and over: Take 10 drops up to 3 times per day. Consult a physician for use in children under 12 years of age.

Other Information

Tamper resistant. If seal is broken, do not use. After opening, close container tightly and store at room temperature away from heat.

Inactive Ingredients

20% ethanol, purified water.

Label

Est 1985

Professional Formulas

Complementary Health

Dysfunctional Bleeding Drops

Homeopathic Remedy

2 FL. OZ. (59 mL)

Label Image (C138 Thumb)

Label Image (C138 Thumb)

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