DYSFUNCTIONAL BLEEDING DROPS 2138- dysfunctional bleeding drops liquid

Dysfunctional Bleeding Drops by

Drug Labeling and Warnings

Dysfunctional Bleeding Drops by is a Homeopathic medication manufactured, distributed, or labeled by Professional Complementary Health Formulas, Natural Pharmaceutical Manufacturing LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.*

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.

Keep out of the reach of children.

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)

INGREDIENTS AND APPEARANCE

DYSFUNCTIONAL BLEEDING DROPS  2138
dysfunctional bleeding drops liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63083-2138
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BOS TAURUS HYPOTHALAMUS (UNII: S6G2NLH4Y7) (BOS TAURUS HYPOTHALAMUS - UNII:S6G2NLH4Y7)	BOS TAURUS HYPOTHALAMUS	6 [hp_X]  in 59 mL
BEEF LIVER (UNII: W8N8R55022) (BEEF LIVER - UNII:W8N8R55022)	BEEF LIVER	6 [hp_X]  in 59 mL
BOS TAURUS OVARY (UNII: 66LZN1C747) (BOS TAURUS OVARY - UNII:66LZN1C747)	BOS TAURUS OVARY	6 [hp_X]  in 59 mL
BOS TAURUS PITUITARY GLAND, POSTERIOR (UNII: 7JM57I419K) (BOS TAURUS PITUITARY GLAND, POSTERIOR - UNII:7JM57I419K)	BOS TAURUS PITUITARY GLAND, POSTERIOR	6 [hp_X]  in 59 mL
BOS TAURUS SPLEEN (UNII: 190Q9MB3U3) (BOS TAURUS SPLEEN - UNII:190Q9MB3U3)	BOS TAURUS SPLEEN	6 [hp_X]  in 59 mL
SUS SCROFA UTERUS (UNII: 2595C75F1P) (SUS SCROFA UTERUS - UNII:2595C75F1P)	SUS SCROFA UTERUS	6 [hp_X]  in 59 mL
CHASTE TREE FRUIT (UNII: 433OSF3U8A) (CHASTE TREE FRUIT - UNII:433OSF3U8A)	CHASTE TREE FRUIT	8 [hp_X]  in 59 mL
COFFEA ARABICA SEED, ROASTED (UNII: 9H58JRT35E) (COFFEA ARABICA SEED, ROASTED - UNII:9H58JRT35E)	COFFEA ARABICA SEED, ROASTED	8 [hp_X]  in 59 mL
CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ)	CALENDULA OFFICINALIS FLOWERING TOP	9 [hp_X]  in 59 mL
GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV)	GOLDENSEAL	9 [hp_X]  in 59 mL
CAPSELLA BURSA-PASTORIS WHOLE (UNII: W0X9457M59) (CAPSELLA BURSA-PASTORIS WHOLE - UNII:W0X9457M59)	CAPSELLA BURSA-PASTORIS WHOLE	12 [hp_X]  in 59 mL
CHAMAELIRIUM LUTEUM ROOT (UNII: DQV54Y5H3U) (CHAMAELIRIUM LUTEUM ROOT - UNII:DQV54Y5H3U)	CHAMAELIRIUM LUTEUM ROOT	12 [hp_X]  in 59 mL
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4)	SILICON DIOXIDE	12 [hp_X]  in 59 mL
TRIFOLIUM PRATENSE FLOWER (UNII: 4JS0838828) (TRIFOLIUM PRATENSE FLOWER - UNII:4JS0838828)	TRIFOLIUM PRATENSE FLOWER	12 [hp_X]  in 59 mL
VIBURNUM OPULUS BARK (UNII: T1UG6H6805) (VIBURNUM OPULUS BARK - UNII:T1UG6H6805)	VIBURNUM OPULUS BARK	12 [hp_X]  in 59 mL
APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z)	APIS MELLIFERA	30 [hp_X]  in 59 mL
SELENICEREUS GRANDIFLORUS STEM (UNII: 7114SV0MYK) (SELENICEREUS GRANDIFLORUS STEM - UNII:7114SV0MYK)	SELENICEREUS GRANDIFLORUS STEM	30 [hp_X]  in 59 mL
COLLINSONIA CANADENSIS ROOT (UNII: O2630F3XDR) (COLLINSONIA CANADENSIS ROOT - UNII:O2630F3XDR)	COLLINSONIA CANADENSIS ROOT	30 [hp_X]  in 59 mL
GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q)	GELSEMIUM SEMPERVIRENS ROOT	30 [hp_X]  in 59 mL
STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919)	STRYCHNOS NUX-VOMICA SEED	30 [hp_X]  in 59 mL
VERATRUM ALBUM ROOT (UNII: QNS6W5US1Z) (VERATRUM ALBUM ROOT - UNII:QNS6W5US1Z)	VERATRUM ALBUM ROOT	30 [hp_X]  in 59 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63083-2138-2	59 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	08/15/1985

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		08/15/1984

Labeler - Professional Complementary Health Formulas (167339027)

Registrant - Natural Pharmaceutical Manufacturing LLC (015624923)

Establishment
Name	Address	ID/FEI	Business Operations
Natural Pharmaceutical Manufacturing LLC		015624923	manufacture(63083-2138)