R309

R309
SPL v1
SPL
SPL Set ID f777015f-1df6-4821-af63-543175313aba
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 (12 [hp_X]) Carbonate Ion (16 [hp_X]) Dimpylate Malaoxon Silicon Dioxide Thuja Occidentalis Leaf Dichlorvos Phosfolan
Inactive Ingredients
Alcohol Water

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 1984-08-15

Description

Cimicifuga racemosa 3X Gelsemium sempervirens 3X Natrum carbonicum 3X Diazinon 12X Malathion 12X Silicea 12X Thuja occidentalis 12X Dichlorvos (DDVP) 16X Phospholan 16X


Medication Information

Description

Cimicifuga racemosa 3X Gelsemium sempervirens 3X Natrum carbonicum 3X Diazinon 12X Malathion 12X Silicea 12X Thuja occidentalis 12X Dichlorvos (DDVP) 16X Phospholan 16X

Label

Est 1985

Professional Formulas

Complementary Health

Organophosphate 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, nausea or vomiting, abdominal cramps, watery eyes, runny nose, coughing, or weakness.*

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

Natrum carbonicum 3X

Diazinon 12X

Malathion 12X

Silicea 12X

Thuja occidentalis 12X

Dichlorvos (DDVP) 16X

Phospholan 16X

Inactive Ingredients

40% ethanol, purified water.


Structured Label Content

Label (LABEL)

Est 1985

Professional Formulas

Complementary Health

Organophosphate 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, nausea or vomiting, abdominal cramps, watery eyes, runny nose, coughing, or weakness.*

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

Natrum carbonicum 3X

Diazinon 12X

Malathion 12X

Silicea 12X

Thuja occidentalis 12X

Dichlorvos (DDVP) 16X

Phospholan 16X

Inactive Ingredients (INACTIVE INGREDIENTS)

40% ethanol, purified water.


Advanced Ingredient Data


Raw Label Data

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