R317

R317
SPL v1
SPL
SPL Set ID 01a1b313-3edb-4907-9d9b-bb1d1061b4ef
Route
ORAL
Published
Effective Date 2019-10-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Black Cohosh (3 [hp_X]) Gelsemium Sempervirens Root (6 [hp_X]) Strychnos Nux-vomica Seed (10 [hp_X]) Berberis Vulgaris Root Bark (12 [hp_X]) Chelidonium Majus Whole (14 [hp_X]) Aniline Cyclohexanol Estradiol Mercuric Cation Toluene Musk Xylene Benzene
Inactive Ingredients
Alcohol Water

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 1984-08-15

Description

Cimicifuga racemosa 3X Gelsemium sempervirens 3X Nux vomica 6X Berberis vulgaris 10X Chelidonium majus 10X Anilinum 12X Cyclohexanol 12X Estradiol benzoate 12X Phenylmercuric nitrate 12X Toluol 12X Xylol 12X Benzinum 14X


Medication Information

Description

Cimicifuga racemosa 3X Gelsemium sempervirens 3X Nux vomica 6X Berberis vulgaris 10X Chelidonium majus 10X Anilinum 12X Cyclohexanol 12X Estradiol benzoate 12X Phenylmercuric nitrate 12X Toluol 12X Xylol 12X Benzinum 14X

Label

Est 1985

Professional Formulas

Complementary Health

Solvent/Small Ring Combination

Homeopathic Remedy

1 FL. OZ. (29.5 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

Consult a doctor if condition worsens or if symptoms persist. 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 headache, cough, minor sore throat, red or irritated skin or eyes, weakness, nausea, or vomiting.*

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

Cimicifuga racemosa 3X

Gelsemium sempervirens 3X

Nux vomica 6X

Berberis vulgaris 10X

Chelidonium majus 10X

Anilinum 12X

Cyclohexanol 12X

Estradiol benzoate 12X

Phenylmercuric nitrate 12X

Toluol 12X

Xylol 12X

Benzinum 14X

Inactive Ingredients

40% ethanol, purified water.


Structured Label Content

Label (LABEL)

Est 1985

Professional Formulas

Complementary Health

Solvent/Small Ring Combination

Homeopathic Remedy

1 FL. OZ. (29.5 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)

Consult a doctor if condition worsens or if symptoms persist. 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 headache, cough, minor sore throat, red or irritated skin or eyes, weakness, nausea, or vomiting.*

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)

Cimicifuga racemosa 3X

Gelsemium sempervirens 3X

Nux vomica 6X

Berberis vulgaris 10X

Chelidonium majus 10X

Anilinum 12X

Cyclohexanol 12X

Estradiol benzoate 12X

Phenylmercuric nitrate 12X

Toluol 12X

Xylol 12X

Benzinum 14X

Inactive Ingredients (INACTIVE INGREDIENTS)

40% ethanol, purified water.


Advanced Ingredient Data


Raw Label Data

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