Cct

Cct
SPL v1
SPL
SPL Set ID 71d46da9-9e1d-43da-8664-b5579e9fd4e3
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]) Aconitum Napellus Whole (3 [hp_X]) Amaryllis Belladonna Whole (4 [hp_X]) Bryonia Alba Root (5 [hp_X]) Pulsatilla Montana Whole (6 [hp_X]) Ipecac Arsenic Cation (3+) Drosera Rotundifolia Whole
Inactive Ingredients
Alcohol Water

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 1984-08-15

Description

Spongia tosta 2X Aconitum napellus 3X Belladonna 3X Bryonia 3X Pulsatilla 4X Ipecacuanha 5X Arsenicum album 6X Drosera rotundifolia 6X


Medication Information

Description

Spongia tosta 2X Aconitum napellus 3X Belladonna 3X Bryonia 3X Pulsatilla 4X Ipecacuanha 5X Arsenicum album 6X Drosera rotundifolia 6X

Label

Est 1985

Professional Formulas

Complementary Health

Cough Tonic

Homeopathic Remedy

4 FL. OZ. (118 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 liquid under tongue 30 minutes before/after meals. Adults and children 12 years and over: Take one teaspoon up to 2 times per day. Consult a physician for use in children under 12 years of age.

Indications

Temporarily reduces the intensity of coughing and congestion.*

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

Aconitum napellus 3X

Belladonna 3X

Bryonia 3X

Pulsatilla 4X

Ipecacuanha 5X

Arsenicum album 6X

Drosera rotundifolia 6X

Inactive Ingredients

Glycyrrhiza glabra root extract (1:1), polygala tenuifolia root extract (1:1), grindelia camporum aerial parts extract (1:1), inula helenium root extract (1:1), thymus vulgaris leaves extract (1:1), verbascum thapsus leaves extract (1:2), asclepias tuberosa root extract (1:1), zingiber officinale root extract (1:1), pimpinella anisum seed extract (1:1), 15% vegetable glycerin (from soy), 10% ethanol, 5% cherry extract, purified water.


Structured Label Content

Label (LABEL)

Est 1985

Professional Formulas

Complementary Health

Cough Tonic

Homeopathic Remedy

4 FL. OZ. (118 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 liquid under tongue 30 minutes before/after meals. Adults and children 12 years and over: Take one teaspoon up to 2 times per day. Consult a physician for use in children under 12 years of age.

Indications (INDICATIONS)

Temporarily reduces the intensity of coughing and congestion.*

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

Aconitum napellus 3X

Belladonna 3X

Bryonia 3X

Pulsatilla 4X

Ipecacuanha 5X

Arsenicum album 6X

Drosera rotundifolia 6X

Inactive Ingredients (INACTIVE INGREDIENTS)

Glycyrrhiza glabra root extract (1:1), polygala tenuifolia root extract (1:1), grindelia camporum aerial parts extract (1:1), inula helenium root extract (1:1), thymus vulgaris leaves extract (1:1), verbascum thapsus leaves extract (1:2), asclepias tuberosa root extract (1:1), zingiber officinale root extract (1:1), pimpinella anisum seed extract (1:1), 15% vegetable glycerin (from soy), 10% ethanol, 5% cherry extract, purified water.


Advanced Ingredient Data


Raw Label Data

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