R236

R236
SPL v1
SPL
SPL Set ID b24596b6-8e15-40d4-8800-39c8160e61f3
Route
ORAL
Published
Effective Date 2019-10-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Populus Tremuloides Bark (1 [hp_X]) Saw Palmetto (3 [hp_X]) Apis Mellifera (4 [hp_X]) Baptisia Tinctoria Whole (5 [hp_X]) Camphor (natural) (6 [hp_X]) Capsicum (12 [hp_X]) Piper Cubeba Fruit Equisetum Hyemale Whole Ononis Repens Whole Rubia Tinctorum Root Scrophularia Nodosa Whole Solidago Virgaurea Flowering Top Urtica Urens Whole Arctostaphylos Tomentosa Whole Petroselinum Crispum Root Berberis Vulgaris Root Bark Lytta Vesicatoria Agathosma Betulina Leaf Wood Creosote Drimia Maritima Bulb Turpentine Oil Mercuric Cation
Inactive Ingredients
Alcohol Water

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 1984-08-15

Description

Populus tremuloides 1X Sabal serrulata 1X Apis mellifica 3X Baptisia tinctoria 3X Camphora 3X Capsicum annuum 3X Cubeba officinalis 3X Equisetum hyemale 3X Ononis spinosa 3X Rubia tinctorum 3X Scrophularia nodosa 3X Solidago virgaurea 3X Urtica urens 3X Uva-ursi 3X Petroselinum sativum 4X Berberis vulgaris 5X Cantharis 5X Barosma crenata 6X Kreosotum 6X Scilla maritima 6X Terebinthina 6X Mercurius corrosivus 12X


Medication Information

Description

Populus tremuloides 1X Sabal serrulata 1X Apis mellifica 3X Baptisia tinctoria 3X Camphora 3X Capsicum annuum 3X Cubeba officinalis 3X Equisetum hyemale 3X Ononis spinosa 3X Rubia tinctorum 3X Scrophularia nodosa 3X Solidago virgaurea 3X Urtica urens 3X Uva-ursi 3X Petroselinum sativum 4X Berberis vulgaris 5X Cantharis 5X Barosma crenata 6X Kreosotum 6X Scilla maritima 6X Terebinthina 6X Mercurius corrosivus 12X

Label

Est 1985

Professional Formulas

Complementary Health

Populus 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 constipation, diarrhea, or frequent urination.*

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

Populus tremuloides 1X

Sabal serrulata 1X

Apis mellifica 3X

Baptisia tinctoria 3X

Camphora 3X

Capsicum annuum 3X

Cubeba officinalis 3X

Equisetum hyemale 3X

Ononis spinosa 3X

Rubia tinctorum 3X

Scrophularia nodosa 3X

Solidago virgaurea 3X

Urtica urens 3X

Uva-ursi 3X

Petroselinum sativum 4X

Berberis vulgaris 5X

Cantharis 5X

Barosma crenata 6X

Kreosotum 6X

Scilla maritima 6X

Terebinthina 6X

Mercurius corrosivus 12X

Inactive Ingredients

40% ethanol, purified water.


Structured Label Content

Label (LABEL)

Est 1985

Professional Formulas

Complementary Health

Populus 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 constipation, diarrhea, or frequent urination.*

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)

Populus tremuloides 1X

Sabal serrulata 1X

Apis mellifica 3X

Baptisia tinctoria 3X

Camphora 3X

Capsicum annuum 3X

Cubeba officinalis 3X

Equisetum hyemale 3X

Ononis spinosa 3X

Rubia tinctorum 3X

Scrophularia nodosa 3X

Solidago virgaurea 3X

Urtica urens 3X

Uva-ursi 3X

Petroselinum sativum 4X

Berberis vulgaris 5X

Cantharis 5X

Barosma crenata 6X

Kreosotum 6X

Scilla maritima 6X

Terebinthina 6X

Mercurius corrosivus 12X

Inactive Ingredients (INACTIVE INGREDIENTS)

40% ethanol, purified water.


Advanced Ingredient Data


Raw Label Data

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