C172

C172
SPL v1
SPL
SPL Set ID 73822225-f10c-4d2a-8cd8-ea31dd2b2789
Route
ORAL
Published
Effective Date 2019-10-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Pseudognaphalium Obtusifolium Whole (4 [hp_X]) Aviscumine (6 [hp_X]) Aconitum Napellus Whole (8 [hp_X]) Strychnos Ignatii Seed (12 [hp_X]) Rhododendron Tomentosum Leafy Twig Toxicodendron Pubescens Leaf Sulfur Magnesium Cation Arsenic Cation (3+) Causticum Zinc
Inactive Ingredients
Alcohol Water

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 1984-08-15

Description

Gnaphalium polycephalum 4X Viscum album 4X Aconitum napellus 6X Ignatia amara 6X Ledum palustre 6X Rhus toxicodendron 6X Sulphur 6X, 12X Magnesia phosphorica 8X Arsenicum album 12X Causticum 12X Zincum metallicum 12X


Medication Information

Description

Gnaphalium polycephalum 4X Viscum album 4X Aconitum napellus 6X Ignatia amara 6X Ledum palustre 6X Rhus toxicodendron 6X Sulphur 6X, 12X Magnesia phosphorica 8X Arsenicum album 12X Causticum 12X Zincum metallicum 12X

Label

Est 1985

Professional Formulas

Complementary Health

Restless Leg 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

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 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 temporary relief of itching or tingling legs, or an impulse to move legs.*

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

Gnaphalium polycephalum 4X

Viscum album 4X

Aconitum napellus 6X

Ignatia amara 6X

Ledum palustre 6X

Rhus toxicodendron 6X

Sulphur 6X, 12X

Magnesia phosphorica 8X

Arsenicum album 12X

Causticum 12X

Zincum metallicum 12X

Inactive Ingredients

20% ethanol, purified water.


Structured Label Content

Label (LABEL)

Est 1985

Professional Formulas

Complementary Health

Restless Leg 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)

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 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 temporary relief of itching or tingling legs, or an impulse to move legs.*

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)

Gnaphalium polycephalum 4X

Viscum album 4X

Aconitum napellus 6X

Ignatia amara 6X

Ledum palustre 6X

Rhus toxicodendron 6X

Sulphur 6X, 12X

Magnesia phosphorica 8X

Arsenicum album 12X

Causticum 12X

Zincum metallicum 12X

Inactive Ingredients (INACTIVE INGREDIENTS)

20% ethanol, purified water.


Advanced Ingredient Data


Raw Label Data

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