R204

R204
SPL v1
SPL
SPL Set ID 312cac13-2009-4b8f-a09b-9be2d2801df5
Route
ORAL
Published
Effective Date 2019-10-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Saw Palmetto (2 [hp_X]) Berberis Vulgaris Root Bark (3 [hp_X]) Chondrodendron Tomentosum Root (4 [hp_X]) Lytta Vesicatoria (6 [hp_X]) Causticum (12 [hp_X]) Nitric Acid Aluminum Oxide Lead
Inactive Ingredients
Alcohol Water

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 1984-08-15

Description

Sabal serrulata 2X Berberis vulgaris 3X Pareira brava 3X Cantharis 4X Causticum 4X Nitricum acidum 6X Alumina 12X Plumbum aceticum 12X


Medication Information

Description

Sabal serrulata 2X Berberis vulgaris 3X Pareira brava 3X Cantharis 4X Causticum 4X Nitricum acidum 6X Alumina 12X Plumbum aceticum 12X

Label

Est 1985

Professional Formulas

Complementary Health

Alumina 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, if symptoms persist, or are accompanied by fever, vomiting, or bloody or cloudy urine. 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 constipation, mild abdominal pain, or urinary discomfort.*

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

Sabal serrulata 2X

Berberis vulgaris 3X

Pareira brava 3X

Cantharis 4X

Causticum 4X

Nitricum acidum 6X

Alumina 12X

Plumbum aceticum 12X

Inactive Ingredients

40% ethanol, purified water.


Structured Label Content

Label (LABEL)

Est 1985

Professional Formulas

Complementary Health

Alumina 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, if symptoms persist, or are accompanied by fever, vomiting, or bloody or cloudy urine. 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 constipation, mild abdominal pain, or urinary discomfort.*

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)

Sabal serrulata 2X

Berberis vulgaris 3X

Pareira brava 3X

Cantharis 4X

Causticum 4X

Nitricum acidum 6X

Alumina 12X

Plumbum aceticum 12X

Inactive Ingredients (INACTIVE INGREDIENTS)

40% ethanol, purified water.


Advanced Ingredient Data


Raw Label Data

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