R258

R258
SPL v1
SPL
SPL Set ID 938dd5da-74f4-4f2a-bfc1-e54163473dc7
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 (2 [hp_X]) Conium Maculatum Flowering Top (3 [hp_X]) Aviscumine (4 [hp_X]) Arnica Montana Whole (6 [hp_X]) Kalmia Latifolia Leaf (8 [hp_X]) Amaryllis Belladonna Whole (10 [hp_X]) Lycopodium Clavatum Spore Rauwolfia Serpentina Artichoke Melilotus Officinalis Top Gold Monoiodide Sulfur
Inactive Ingredients
Alcohol Water

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 1984-08-15

Description

Crataegus oxyacantha 2X Conium maculatum 3X Viscum album 3X Arnica montana 4X Kalmia latifolia 4X Belladonna 6X Lycopodium clavatum 6X Rauwolfia serpentina 6X Cynara scolymus 8X Melilotus officinalis 8X Aurum iodatum 10X Sulphur 10X


Medication Information

Description

Crataegus oxyacantha 2X Conium maculatum 3X Viscum album 3X Arnica montana 4X Kalmia latifolia 4X Belladonna 6X Lycopodium clavatum 6X Rauwolfia serpentina 6X Cynara scolymus 8X Melilotus officinalis 8X Aurum iodatum 10X Sulphur 10X

Label

Est 1985

Professional Formulas

Complementary Health

Rauwolfia 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

In case of overdose, get medical help or contact a poison control center right away.

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 headache, dizziness, or vertigo particularly with smoking, excessive drinking of alcohol, obesity, or a poor diet.*

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 2X

Conium maculatum 3X

Viscum album 3X

Arnica montana 4X

Kalmia latifolia 4X

Belladonna 6X

Lycopodium clavatum 6X

Rauwolfia serpentina 6X

Cynara scolymus 8X

Melilotus officinalis 8X

Aurum iodatum 10X

Sulphur 10X

Inactive Ingredients

40% ethanol, purified water.


Structured Label Content

Label (LABEL)

Est 1985

Professional Formulas

Complementary Health

Rauwolfia 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)

In case of overdose, get medical help or contact a poison control center right away.

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 headache, dizziness, or vertigo particularly with smoking, excessive drinking of alcohol, obesity, or a poor diet.*

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 2X

Conium maculatum 3X

Viscum album 3X

Arnica montana 4X

Kalmia latifolia 4X

Belladonna 6X

Lycopodium clavatum 6X

Rauwolfia serpentina 6X

Cynara scolymus 8X

Melilotus officinalis 8X

Aurum iodatum 10X

Sulphur 10X

Inactive Ingredients (INACTIVE INGREDIENTS)

40% ethanol, purified water.


Advanced Ingredient Data


Raw Label Data

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