R420

R420
SPL v1
SPL
SPL Set ID f107e47e-4176-411f-83ac-bb2d0096b3b3
Route
ORAL
Published
Effective Date 2019-10-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Colchicum Autumnale Bulb (4 [hp_X]) Fucus Vesiculosus (6 [hp_X]) Spongia Officinalis Skeleton, Roasted (8 [hp_X]) Oxogluric Acid (10 [hp_X]) Fumaric Acid (12 [hp_X]) Malic Acid Diethyl Oxalacetate Pulsatilla Montana Whole Hyssopus Officinalis Whole Fluoride Ion Thyroid, Unspecified
Inactive Ingredients
Alcohol Water

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 1984-08-15

Description

Colchicum autumnale 4X Fucus vesiculosus 6X Spongia tosta 6X a-Ketoglutaricum acidum 8X Fumaricum acidum 8X Malicum acidum 8X Natrum oxalaceticum 8X Pulsatilla 8X Thymus 8X Calcarea fluorica 10X Thyroidinum 12X


Medication Information

Description

Colchicum autumnale 4X Fucus vesiculosus 6X Spongia tosta 6X a-Ketoglutaricum acidum 8X Fumaricum acidum 8X Malicum acidum 8X Natrum oxalaceticum 8X Pulsatilla 8X Thymus 8X Calcarea fluorica 10X Thyroidinum 12X

Label

Est 1985

Professional Formulas

Complementary Health

Thyroid Nosode 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

Persistent symptoms may be a sign of a serious condition. If symptoms persist or are accompanied by a fever, rash, or persistent headache, 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 to 15 drops once weekly or monthly. If mild symptoms are present, 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, cough, minor abdominal or back pain, flatulence, nausea, or dry, itchy skin.*

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

Colchicum autumnale 4X

Fucus vesiculosus 6X

Spongia tosta 6X

a-Ketoglutaricum acidum 8X

Fumaricum acidum 8X

Malicum acidum 8X

Natrum oxalaceticum 8X

Pulsatilla 8X

Thymus 8X

Calcarea fluorica 10X

Thyroidinum 12X

Inactive Ingredients

40% ethanol, purified water.


Structured Label Content

Label (LABEL)

Est 1985

Professional Formulas

Complementary Health

Thyroid Nosode 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)

Persistent symptoms may be a sign of a serious condition. If symptoms persist or are accompanied by a fever, rash, or persistent headache, 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 to 15 drops once weekly or monthly. If mild symptoms are present, 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, cough, minor abdominal or back pain, flatulence, nausea, or dry, itchy skin.*

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)

Colchicum autumnale 4X

Fucus vesiculosus 6X

Spongia tosta 6X

a-Ketoglutaricum acidum 8X

Fumaricum acidum 8X

Malicum acidum 8X

Natrum oxalaceticum 8X

Pulsatilla 8X

Thymus 8X

Calcarea fluorica 10X

Thyroidinum 12X

Inactive Ingredients (INACTIVE INGREDIENTS)

40% ethanol, purified water.


Advanced Ingredient Data


Raw Label Data

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