R209

R209
SPL v1
SPL
SPL Set ID cca7da01-b28b-46c3-b025-d0bd12074aa1
Route
ORAL
Published
Effective Date 2019-10-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Arnica Montana Whole (4 [hp_X]) Datura Stramonium (6 [hp_X]) Semecarpus Anacardium Juice (8 [hp_X]) Barium Cation (12 [hp_X]) Causticum Strychnos Ignatii Seed Calcium Cation Potassium Phosphate, Unspecified Form Aconitum Napellus Whole
Inactive Ingredients
Alcohol Water

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 1984-08-15

Description

Arnica montana 4X Stramonium 4X Anacardium orientale 6X Baryta muriatica 6X Causticum 6X Ignatia amara 6X Calcarea iodata 8X Kali phosphoricum 8X Aconitum napellus 12X Baryta carbonica 12X


Medication Information

Description

Arnica montana 4X Stramonium 4X Anacardium orientale 6X Baryta muriatica 6X Causticum 6X Ignatia amara 6X Calcarea iodata 8X Kali phosphoricum 8X Aconitum napellus 12X Baryta carbonica 12X

Label

Est 1985

Professional Formulas

Complementary Health

Baryta 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

If symptoms do not improve or are accompanied by a fever, 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 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 minor sore throat, cough, sneezing, runny nose, or nasal congestion.*

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

Arnica montana 4X

Stramonium 4X

Anacardium orientale 6X

Baryta muriatica 6X

Causticum 6X

Ignatia amara 6X

Calcarea iodata 8X

Kali phosphoricum 8X

Aconitum napellus 12X

Baryta carbonica 12X

Inactive Ingredients

40% ethanol, purified water.


Structured Label Content

Label (LABEL)

Est 1985

Professional Formulas

Complementary Health

Baryta 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)

If symptoms do not improve or are accompanied by a fever, 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 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 minor sore throat, cough, sneezing, runny nose, or nasal congestion.*

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)

Arnica montana 4X

Stramonium 4X

Anacardium orientale 6X

Baryta muriatica 6X

Causticum 6X

Ignatia amara 6X

Calcarea iodata 8X

Kali phosphoricum 8X

Aconitum napellus 12X

Baryta carbonica 12X

Inactive Ingredients (INACTIVE INGREDIENTS)

40% ethanol, purified water.


Advanced Ingredient Data


Raw Label Data

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