C124

C124
SPL v1
SPL
SPL Set ID d05bfbbe-d19d-4fd5-8679-bf17d0b61840
Route
ORAL
Published
Effective Date 2019-10-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Chaste Tree Fruit (3 [hp_X]) Caulophyllum Thalictroides Root (6 [hp_X]) Black Cohosh (15 [hp_X]) Magnesium Cation (30 [hp_X]) Bos Taurus Pituitary Gland, Posterior Pulsatilla Montana Whole Sepia Officinalis Juice Spongia Officinalis Skeleton, Roasted Thyroid, Unspecified Viburnum Opulus Bark Lachesis Muta Venom Estrogens, Conjugated Progesterone
Inactive Ingredients
Alcohol Water

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 1984-08-15

Description

Agnus castus 3X Caulophyllum thalictroides 6X Cimicifuga racemosa 6X Magnesia phosphorica 6X Pituitary 6X Pulsatilla 6X Sepia 6X Spongia tosta 6X Thyroid 6X Viburnum opulus 6X Lachesis mutus 15X Estrogen 30X Progesterone 30X


Medication Information

Description

Agnus castus 3X Caulophyllum thalictroides 6X Cimicifuga racemosa 6X Magnesia phosphorica 6X Pituitary 6X Pulsatilla 6X Sepia 6X Spongia tosta 6X Thyroid 6X Viburnum opulus 6X Lachesis mutus 15X Estrogen 30X Progesterone 30X

Label

Est 1985

Professional Formulas

Complementary Health

PMS 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

In case of overdose, get medical help or contact a poison control center right away.

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 for up to 6 weeks. For immediate onset of symptoms, take 10 to 15 drops every 15 minutes up to 3 hours. For less severe symptoms, take 10-15 drops hourly up to 8 hours. Consult a physician for use in children under 12 years of age.

Indications

For the temporary relief of cramping, lower abdominal or back pain, irritability, fatigue, or debility associated with pre-menstrual syndrome.*

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

Agnus castus 3X

Caulophyllum thalictroides 6X

Cimicifuga racemosa 6X

Magnesia phosphorica 6X

Pituitary 6X

Pulsatilla 6X

Sepia 6X

Spongia tosta 6X

Thyroid 6X

Viburnum opulus 6X

Lachesis mutus 15X

Estrogen 30X

Progesterone 30X

Inactive Ingredients

20% ethanol, purified water.


Structured Label Content

Label (LABEL)

Est 1985

Professional Formulas

Complementary Health

PMS 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)

In case of overdose, get medical help or contact a poison control center right away.

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 for up to 6 weeks. For immediate onset of symptoms, take 10 to 15 drops every 15 minutes up to 3 hours. For less severe symptoms, take 10-15 drops hourly up to 8 hours. Consult a physician for use in children under 12 years of age.

Indications (INDICATIONS)

For the temporary relief of cramping, lower abdominal or back pain, irritability, fatigue, or debility associated with pre-menstrual syndrome.*

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)

Agnus castus 3X

Caulophyllum thalictroides 6X

Cimicifuga racemosa 6X

Magnesia phosphorica 6X

Pituitary 6X

Pulsatilla 6X

Sepia 6X

Spongia tosta 6X

Thyroid 6X

Viburnum opulus 6X

Lachesis mutus 15X

Estrogen 30X

Progesterone 30X

Inactive Ingredients (INACTIVE INGREDIENTS)

20% ethanol, purified water.


Advanced Ingredient Data


Raw Label Data

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