C39

C39
SPL v1
SPL
SPL Set ID 81579a5b-3e1d-452e-8e96-e4b4b500851a
Route
ORAL
Published
Effective Date 2019-10-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Equisetum Arvense Top (2 [hp_X]) Smilax Ornata Root (3 [hp_X]) Berberis Vulgaris Root Bark (6 [hp_X]) Hawthorn Leaf With Flower (12 [hp_X]) Digitalis (30 [hp_X]) Carbonate Ion Lycopodium Clavatum Spore Nitric Acid Mercuric Cation Oxalic Acid Uric Acid
Inactive Ingredients
Alcohol Water

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 1984-08-15

Description

Equisetum arvense 2X Sarsaparilla 3X Berberis vulgaris 6X Crataegus oxyacantha 6X Digitalis purpurea 6X Kali carbonicum 6X Lycopodium clavatum 6X Nitricum acidum 6X Mercurius corrosivus 12X Oxalicum acidum 30X Uricum acidum 30X


Medication Information

Description

Equisetum arvense 2X Sarsaparilla 3X Berberis vulgaris 6X Crataegus oxyacantha 6X Digitalis purpurea 6X Kali carbonicum 6X Lycopodium clavatum 6X Nitricum acidum 6X Mercurius corrosivus 12X Oxalicum acidum 30X Uricum acidum 30X

Label

Est 1985

Professional Formulas

Complementary Health

Kidney Stone 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

Severe or persistent symptoms may be a sign of a serious condition. Consult a doctor promptly if symptoms are severe, sharp, or worsen during urination. 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 mild pain in the back or abdomen.*

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

Equisetum arvense 2X

Sarsaparilla 3X

Berberis vulgaris 6X

Crataegus oxyacantha 6X

Digitalis purpurea 6X

Kali carbonicum 6X

Lycopodium clavatum 6X

Nitricum acidum 6X

Mercurius corrosivus 12X

Oxalicum acidum 30X

Uricum acidum 30X

Inactive Ingredients

20% ethanol, purified water.


Structured Label Content

Label (LABEL)

Est 1985

Professional Formulas

Complementary Health

Kidney Stone 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)

Severe or persistent symptoms may be a sign of a serious condition. Consult a doctor promptly if symptoms are severe, sharp, or worsen during urination. 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 mild pain in the back or abdomen.*

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)

Equisetum arvense 2X

Sarsaparilla 3X

Berberis vulgaris 6X

Crataegus oxyacantha 6X

Digitalis purpurea 6X

Kali carbonicum 6X

Lycopodium clavatum 6X

Nitricum acidum 6X

Mercurius corrosivus 12X

Oxalicum acidum 30X

Uricum acidum 30X

Inactive Ingredients (INACTIVE INGREDIENTS)

20% ethanol, purified water.


Advanced Ingredient Data


Raw Label Data

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