C14

C14
SPL v1
SPL
SPL Set ID 533c8124-d8bc-404a-9f1f-680d7ef8eb36
Route
ORAL
Published
Effective Date 2019-10-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Spongia Officinalis Skeleton, Roasted (2 [hp_X]) Amaryllis Belladonna Whole (3 [hp_X]) Ipecac (4 [hp_X]) Rumex Crispus Root (6 [hp_X]) Polygala Senega Whole (12 [hp_X]) Potassium Cation Mentha X Piperita Whole Pulsatilla Montana Whole Arsenic Cation (3+) Drosera Rotundifolia Whole Calcium Sulfide Sanguinaria Canadensis Root Bryonia Alba Root Dichromate Ion
Inactive Ingredients
Alcohol Water

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 1984-08-15

Description

Spongia tosta 2X Belladonna 3X Ipecacuanha 3X Rumex crispus 3X Senega officinalis 3X Kali sulphuricum 4X Mentha piperita 4X Pulsatilla 4X Arsenicum iodatum 6X Drosera rotundifolia 6X Hepar sulphuris calcareum 6X Sanguinaria canadensis 6X Bryonia 12X Kali bichromicum 12X


Medication Information

Description

Spongia tosta 2X Belladonna 3X Ipecacuanha 3X Rumex crispus 3X Senega officinalis 3X Kali sulphuricum 4X Mentha piperita 4X Pulsatilla 4X Arsenicum iodatum 6X Drosera rotundifolia 6X Hepar sulphuris calcareum 6X Sanguinaria canadensis 6X Bryonia 12X Kali bichromicum 12X

Label

Est 1985

Professional Formulas

Complementary Health

Cough 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

A persistent cough may be a sign of a serious condition. If cough persists, tends to recur, or is accompanied by a fever, rash, or other symptoms, consult 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 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

Temporarily reduces the intensity of coughing.*

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

Spongia tosta 2X

Belladonna 3X

Ipecacuanha 3X

Rumex crispus 3X

Senega officinalis 3X

Kali sulphuricum 4X

Mentha piperita 4X

Pulsatilla 4X

Arsenicum iodatum 6X

Drosera rotundifolia 6X

Hepar sulphuris calcareum 6X

Sanguinaria canadensis 6X

Bryonia 12X

Kali bichromicum 12X

Inactive Ingredients

20% ethanol, purified water.


Structured Label Content

Label (LABEL)

Est 1985

Professional Formulas

Complementary Health

Cough 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)

A persistent cough may be a sign of a serious condition. If cough persists, tends to recur, or is accompanied by a fever, rash, or other symptoms, consult 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 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)

Temporarily reduces the intensity of coughing.*

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)

Spongia tosta 2X

Belladonna 3X

Ipecacuanha 3X

Rumex crispus 3X

Senega officinalis 3X

Kali sulphuricum 4X

Mentha piperita 4X

Pulsatilla 4X

Arsenicum iodatum 6X

Drosera rotundifolia 6X

Hepar sulphuris calcareum 6X

Sanguinaria canadensis 6X

Bryonia 12X

Kali bichromicum 12X

Inactive Ingredients (INACTIVE INGREDIENTS)

20% ethanol, purified water.


Advanced Ingredient Data


Raw Label Data

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