C46

C46
SPL v1
SPL
SPL Set ID 4456c022-5aac-49b4-b976-b629525f3d49
Route
ORAL
Published
Effective Date 2019-10-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ginger (3 [hp_X]) Salix Alba Bark (6 [hp_X]) Aconitum Napellus Whole Arsenic Cation (3+) Amaryllis Belladonna Whole Bryonia Alba Root Capsicum Causticum Cinchona Officinalis Bark Hypericum Perforatum Whole Toxicodendron Pubescens Leaf Vitamin A Ascorbic Acid .alpha.-tocopherol Acetaminophen Aspirin Ibuprofen
Inactive Ingredients
Alcohol Water

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 1984-08-15

Description

Zingiber officinale 3X Salix alba 3X, 6X Aconitum napellus 6X Arsenicum album 6X Belladonna 6X Bryonia 6X Capsicum annuum 6X Causticum 6X Cinchona officinalis 6X Hypericum perforatum 6X Rhus toxicodendron 6X Vitamin A 6X Vitamin C 6X Vitamin E 6X Acetaminophen 6X, 30X Aspirin 6X, 30X Ibuprofen 6X, 30X


Medication Information

Description

Zingiber officinale 3X Salix alba 3X, 6X Aconitum napellus 6X Arsenicum album 6X Belladonna 6X Bryonia 6X Capsicum annuum 6X Causticum 6X Cinchona officinalis 6X Hypericum perforatum 6X Rhus toxicodendron 6X Vitamin A 6X Vitamin C 6X Vitamin E 6X Acetaminophen 6X, 30X Aspirin 6X, 30X Ibuprofen 6X, 30X

Label

Est 1985

Professional Formulas

Complementary Health

Pain Formula 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

Temporarily relieves minor aches or pains due to overexertion, fatigue, or illness.*

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

Zingiber officinale 3X

Salix alba 3X, 6X

Aconitum napellus 6X

Arsenicum album 6X

Belladonna 6X

Bryonia 6X

Capsicum annuum 6X

Causticum 6X

Cinchona officinalis 6X

Hypericum perforatum 6X

Rhus toxicodendron 6X

Vitamin A 6X

Vitamin C 6X

Vitamin E 6X

Acetaminophen 6X, 30X

Aspirin 6X, 30X

Ibuprofen 6X, 30X

Inactive Ingredients

20% ethanol, purified water.


Structured Label Content

Label (LABEL)

Est 1985

Professional Formulas

Complementary Health

Pain Formula 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)

Temporarily relieves minor aches or pains due to overexertion, fatigue, or illness.*

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)

Zingiber officinale 3X

Salix alba 3X, 6X

Aconitum napellus 6X

Arsenicum album 6X

Belladonna 6X

Bryonia 6X

Capsicum annuum 6X

Causticum 6X

Cinchona officinalis 6X

Hypericum perforatum 6X

Rhus toxicodendron 6X

Vitamin A 6X

Vitamin C 6X

Vitamin E 6X

Acetaminophen 6X, 30X

Aspirin 6X, 30X

Ibuprofen 6X, 30X

Inactive Ingredients (INACTIVE INGREDIENTS)

20% ethanol, purified water.


Advanced Ingredient Data


Raw Label Data

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