C36

C36
SPL v1
SPL
SPL Set ID ae709e30-7b33-4300-b46c-ff649a16900e
Route
ORAL
Published
Effective Date 2019-10-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hawthorn Leaf With Flower (1 [hp_X]) Valerian (2 [hp_X]) Visnaga Daucoides Fruit (3 [hp_X]) Potassium Phosphate, Unspecified Form (4 [hp_X]) Leonurus Cardiaca Whole (6 [hp_X]) Cytisus Scoparius Flowering Top Spigelia Anthelmia Whole Nerium Oleander Whole Cinchona Officinalis Bark Digitalis Beef Heart Iberis Amara Seed Carbonate Ion Ferula Sumbul Root
Inactive Ingredients
Alcohol Water

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 1984-08-15

Description

Crataegus oxyacantha 1X Valeriana officinalis 1X Ammi visnaga 2X Kali phosphoricum 2X Leonurus cardiaca 2X Cytisus scoparius 3X Spigelia anthelmia 3X Oleander 4X Cinchona officinalis 6X Digitalis purpurea 6X Heart 6X Iberis amara 6X Kali carbonicum 6X Sumbul 6X


Medication Information

Description

Crataegus oxyacantha 1X Valeriana officinalis 1X Ammi visnaga 2X Kali phosphoricum 2X Leonurus cardiaca 2X Cytisus scoparius 3X Spigelia anthelmia 3X Oleander 4X Cinchona officinalis 6X Digitalis purpurea 6X Heart 6X Iberis amara 6X Kali carbonicum 6X Sumbul 6X

Label

Est 1985

Professional Formulas

Complementary Health

Irregular Pulse 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

An irregular heartbeat may be a sign of a serious condition. Consult a doctor promptly if symptoms persist or are accompanied by fluttering in the chest, chest pain, fainting, or dizziness. 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 a minor change in heartbeat due to stress, pain in other areas of the body, smoking, drinking alcohol or caffeine, or taking stimulants.*

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

Crataegus oxyacantha 1X

Valeriana officinalis 1X

Ammi visnaga 2X

Kali phosphoricum 2X

Leonurus cardiaca 2X

Cytisus scoparius 3X

Spigelia anthelmia 3X

Oleander 4X

Cinchona officinalis 6X

Digitalis purpurea 6X

Heart 6X

Iberis amara 6X

Kali carbonicum 6X

Sumbul 6X

Inactive Ingredients

20% ethanol, purified water.


Structured Label Content

Label (LABEL)

Est 1985

Professional Formulas

Complementary Health

Irregular Pulse 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)

An irregular heartbeat may be a sign of a serious condition. Consult a doctor promptly if symptoms persist or are accompanied by fluttering in the chest, chest pain, fainting, or dizziness. 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 a minor change in heartbeat due to stress, pain in other areas of the body, smoking, drinking alcohol or caffeine, or taking stimulants.*

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)

Crataegus oxyacantha 1X

Valeriana officinalis 1X

Ammi visnaga 2X

Kali phosphoricum 2X

Leonurus cardiaca 2X

Cytisus scoparius 3X

Spigelia anthelmia 3X

Oleander 4X

Cinchona officinalis 6X

Digitalis purpurea 6X

Heart 6X

Iberis amara 6X

Kali carbonicum 6X

Sumbul 6X

Inactive Ingredients (INACTIVE INGREDIENTS)

20% ethanol, purified water.


Advanced Ingredient Data


Raw Label Data

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