C138

C138
SPL v1
SPL
SPL Set ID 3e674c1e-c64b-416d-962f-c03493e80085
Route
ORAL
Published
Effective Date 2019-10-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Bos Taurus Hypothalamus (6 [hp_X]) Beef Liver (8 [hp_X]) Bos Taurus Ovary (9 [hp_X]) Bos Taurus Pituitary Gland, Posterior (12 [hp_X]) Bos Taurus Spleen (30 [hp_X]) Sus Scrofa Uterus Chaste Tree Fruit Coffea Arabica Seed, Roasted Calendula Officinalis Flowering Top Goldenseal Capsella Bursa-pastoris Whole Chamaelirium Luteum Root Silicon Dioxide Trifolium Pratense Flower Viburnum Opulus Bark Apis Mellifera Selenicereus Grandiflorus Stem Collinsonia Canadensis Root Gelsemium Sempervirens Root Strychnos Nux-vomica Seed Veratrum Album Root
Inactive Ingredients
Alcohol Water

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 1984-08-15

Description

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


Medication Information

Description

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

Label

Est 1985

Professional Formulas

Complementary Health

Dysfunctional Bleeding Drops

Homeopathic Remedy

2 FL. OZ. (59 mL)

Section 50565-1

Keep out of the reach of children.

Section 53414-9

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

Section 55105-1

*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.

Questions

Professional Formulas

PO Box 2034 Lake Oswego, OR 97035

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.

Indications

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

Other Information

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

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

Inactive Ingredients

20% ethanol, purified water.


Structured Label Content

Label (LABEL)

Est 1985

Professional Formulas

Complementary Health

Dysfunctional Bleeding Drops

Homeopathic Remedy

2 FL. OZ. (59 mL)

Section 50565-1 (50565-1)

Keep out of the reach of children.

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

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

Warnings (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.

Questions (QUESTIONS)

Professional Formulas

PO Box 2034 Lake Oswego, OR 97035

Directions (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.

Indications (INDICATIONS)

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

Other Information (OTHER INFORMATION)

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

Active Ingredients (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

Inactive Ingredients (INACTIVE INGREDIENTS)

20% ethanol, purified water.


Advanced Ingredient Data


Raw Label Data

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