R246

R246
SPL v1
SPL
SPL Set ID fe79986b-7b2d-4cfd-8386-45de02115ca9
Route
ORAL
Published
Effective Date 2019-10-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Bromide Ion (4 [hp_X]) Strychnos Ignatii Seed (8 [hp_X]) Phosphoric Acid (12 [hp_X]) Sepia Officinalis Juice Valeric Acid Scabies Lesion Lysate (human)
Inactive Ingredients
Alcohol Water

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 1984-08-15

Description

Kali bromatum 4X Ignatia amara 4X Phosphoricum acidum 4X Sepia 4X Zincum valerianicum 8X Psorinum 12X


Medication Information

Description

Kali bromatum 4X Ignatia amara 4X Phosphoricum acidum 4X Sepia 4X Zincum valerianicum 8X Psorinum 12X

Label

Est 1985

Professional Formulas

Complementary Health

Sepia 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

Consult a doctor if condition worsens or if symptoms persist. 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 mental fatigue or exhaustion, anxiousness, or insomnia.*

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

Kali bromatum 4X

Ignatia amara 4X

Phosphoricum acidum 4X

Sepia 4X

Zincum valerianicum 8X

Psorinum 12X

Inactive Ingredients

40% ethanol, purified water.


Structured Label Content

Label (LABEL)

Est 1985

Professional Formulas

Complementary Health

Sepia 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)

Consult a doctor if condition worsens or if symptoms persist. 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 mental fatigue or exhaustion, anxiousness, or insomnia.*

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)

Kali bromatum 4X

Ignatia amara 4X

Phosphoricum acidum 4X

Sepia 4X

Zincum valerianicum 8X

Psorinum 12X

Inactive Ingredients (INACTIVE INGREDIENTS)

40% ethanol, purified water.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)