R229

R229
SPL v1
SPL
SPL Set ID 7301c44c-2460-43ad-9cb2-dffdc8ee423c
Route
ORAL
Published
Effective Date 2019-10-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Sanguinaria Canadensis Root (3 [hp_X]) Simaba Cedron Whole (4 [hp_X]) Strychnos Ignatii Seed (6 [hp_X]) Sepia Officinalis Juice (12 [hp_X]) Sulfur Lachesis Muta Venom Tin
Inactive Ingredients
Alcohol Water

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 1984-08-15

Description

Sanguinaria canadensis 3X Cedron 4X Ignatia amara 4X Sepia 4X Sulphur 6X Lachesis mutus 12X Stannum metallicum 12X


Medication Information

Description

Sanguinaria canadensis 3X Cedron 4X Ignatia amara 4X Sepia 4X Sulphur 6X Lachesis mutus 12X Stannum metallicum 12X

Label

Est 1985

Professional Formulas

Complementary Health

Lachesis 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 hot flashes, irritability, fatigue, or debility associated with pre-menstrual syndrome.*

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

Sanguinaria canadensis 3X

Cedron 4X

Ignatia amara 4X

Sepia 4X

Sulphur 6X

Lachesis mutus 12X

Stannum metallicum 12X

Inactive Ingredients

40% ethanol, purified water.


Structured Label Content

Label (LABEL)

Est 1985

Professional Formulas

Complementary Health

Lachesis 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 hot flashes, irritability, fatigue, or debility associated with pre-menstrual syndrome.*

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)

Sanguinaria canadensis 3X

Cedron 4X

Ignatia amara 4X

Sepia 4X

Sulphur 6X

Lachesis mutus 12X

Stannum metallicum 12X

Inactive Ingredients (INACTIVE INGREDIENTS)

40% ethanol, purified water.


Advanced Ingredient Data


Raw Label Data

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