R214

R214
SPL v1
SPL
SPL Set ID 54b605d6-1e58-41b1-865b-1280ed75d494
Route
ORAL
Published
Effective Date 2019-10-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ferula Assa-foetida Resin (4 [hp_X]) Iodide Ion (8 [hp_X]) Stillingia Sylvatica Root (9 [hp_X]) Anhydrous Dibasic Calcium Phosphate (10 [hp_X]) Hekla Lava Sodium Sulfate Anhydrous Araneus Diadematus Mercuric Oxide
Inactive Ingredients
Alcohol Water

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 1984-08-15

Description

Asafoetida 4X Kali iodatum 4X Stillingia sylvatica 4X Calcarea phosphorica 8X Hekla lava 8X Natrum sulphuricum 8X Aranea diadema 9X Mercurius praecipitatus ruber 10X


Medication Information

Description

Asafoetida 4X Kali iodatum 4X Stillingia sylvatica 4X Calcarea phosphorica 8X Hekla lava 8X Natrum sulphuricum 8X Aranea diadema 9X Mercurius praecipitatus ruber 10X

Label

Est 1985

Professional Formulas

Complementary Health

Calcarea 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

If symptoms do not improve or are accompanied by a fever, consult a doctor. 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 tender or aching bones.*

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

Asafoetida 4X

Kali iodatum 4X

Stillingia sylvatica 4X

Calcarea phosphorica 8X

Hekla lava 8X

Natrum sulphuricum 8X

Aranea diadema 9X

Mercurius praecipitatus ruber 10X

Inactive Ingredients

40% ethanol, purified water.


Structured Label Content

Label (LABEL)

Est 1985

Professional Formulas

Complementary Health

Calcarea 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)

If symptoms do not improve or are accompanied by a fever, consult a doctor. 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 tender or aching bones.*

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)

Asafoetida 4X

Kali iodatum 4X

Stillingia sylvatica 4X

Calcarea phosphorica 8X

Hekla lava 8X

Natrum sulphuricum 8X

Aranea diadema 9X

Mercurius praecipitatus ruber 10X

Inactive Ingredients (INACTIVE INGREDIENTS)

40% ethanol, purified water.


Advanced Ingredient Data


Raw Label Data

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