C57

C57
SPL v1
SPL
SPL Set ID b28afc03-b0c7-41cf-86bf-c89d9af514d4
Route
ORAL
Published
Effective Date 2019-10-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Bryonia Alba Root (3 [hp_X]) Colchicum Autumnale Bulb (4 [hp_X]) Solanum Dulcamara Whole (6 [hp_X]) Rhododendron Tomentosum Leafy Twig Ranunculus Bulbosus Whole Apis Mellifera Amaryllis Belladonna Whole Causticum Formica Rufa Kalmia Latifolia Leaf Phytolacca Americana Root Pulsatilla Montana Whole Toxicodendron Pubescens Leaf
Inactive Ingredients
Alcohol Water

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 1984-08-15

Description

Bryonia 3X Colchicum autumnale 3X Dulcamara 4X Ledum palustre 4X Ranunculus bulbosus 4X Apis mellifica 6X Belladonna 6X Causticum 6X Formica rufa 6X Kalmia latifolia 6X Phytolacca decandra 6X Pulsatilla 6X Rhus toxicodendron 6X


Medication Information

Description

Bryonia 3X Colchicum autumnale 3X Dulcamara 4X Ledum palustre 4X Ranunculus bulbosus 4X Apis mellifica 6X Belladonna 6X Causticum 6X Formica rufa 6X Kalmia latifolia 6X Phytolacca decandra 6X Pulsatilla 6X Rhus toxicodendron 6X

Label

Est 1985

Professional Formulas

Complementary Health

Rheuma Pain Drops

Homeopathic Remedy

2 FL. OZ. (59 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 for up to 6 weeks. For immediate onset of symptoms, take 10 to 15 drops every 15 minutes up to 3 hours. For less severe symptoms, take 10-15 drops hourly up to 8 hours. Consult a physician for use in children under 12 years of age.

Indications

For the temporary relief of mild pain or stiffness in joints, muscles, or surrounding tissue, particularly when improved by applying heat.*

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

Bryonia 3X

Colchicum autumnale 3X

Dulcamara 4X

Ledum palustre 4X

Ranunculus bulbosus 4X

Apis mellifica 6X

Belladonna 6X

Causticum 6X

Formica rufa 6X

Kalmia latifolia 6X

Phytolacca decandra 6X

Pulsatilla 6X

Rhus toxicodendron 6X

Inactive Ingredients

20% ethanol, purified water.


Structured Label Content

Label (LABEL)

Est 1985

Professional Formulas

Complementary Health

Rheuma Pain Drops

Homeopathic Remedy

2 FL. OZ. (59 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 for up to 6 weeks. For immediate onset of symptoms, take 10 to 15 drops every 15 minutes up to 3 hours. For less severe symptoms, take 10-15 drops hourly up to 8 hours. Consult a physician for use in children under 12 years of age.

Indications (INDICATIONS)

For the temporary relief of mild pain or stiffness in joints, muscles, or surrounding tissue, particularly when improved by applying heat.*

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)

Bryonia 3X

Colchicum autumnale 3X

Dulcamara 4X

Ledum palustre 4X

Ranunculus bulbosus 4X

Apis mellifica 6X

Belladonna 6X

Causticum 6X

Formica rufa 6X

Kalmia latifolia 6X

Phytolacca decandra 6X

Pulsatilla 6X

Rhus toxicodendron 6X

Inactive Ingredients (INACTIVE INGREDIENTS)

20% ethanol, purified water.


Advanced Ingredient Data


Raw Label Data

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