R411

R411
SPL v1
SPL
SPL Set ID 3b167c3e-10d2-4db1-881d-37f9101315fc
Route
ORAL
Published
Effective Date 2019-10-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Colchicum Autumnale Bulb (4 [hp_X]) Aloe (6 [hp_X]) Citrullus Colocynthis Fruit Pulp (12 [hp_X]) Strychnos Nux-vomica Seed (14 [hp_X]) Helicobacter Pylori Cholera Enterotoxin Subunit B Mercuric Cation Shigella Dysenteriae Lactobacillus Acidophilus Yersinia Enterocolitica
Inactive Ingredients
Alcohol Water

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 1984-08-15

Description

Colchicum autumnale 4X Aloe 6X Colocynthis 6X Nux vomica 6X Campylobacter 12X Cholera 12X Mercurius corrosivus 12X Shigella 12X Thermobacter intestinalis 12X Yersinia nosode 14X


Medication Information

Description

Colchicum autumnale 4X Aloe 6X Colocynthis 6X Nux vomica 6X Campylobacter 12X Cholera 12X Mercurius corrosivus 12X Shigella 12X Thermobacter intestinalis 12X Yersinia nosode 14X

Label

Est 1985

Professional Formulas

Complementary Health

Intestinal Nosode 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

Do not use for more than 30 days. Persistent symptoms may be a sign of a serious condition. If symptoms persist or are accompanied by a fever, rash, or persistent headache, 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 to 15 drops once weekly or monthly. If mild symptoms are present, 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 diarrhea, nausea or vomiting, minor abdominal pain or cramping, occasional headache, or lethargy.*

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

Colchicum autumnale 4X

Aloe 6X

Colocynthis 6X

Nux vomica 6X

Campylobacter 12X

Cholera 12X

Mercurius corrosivus 12X

Shigella 12X

Thermobacter intestinalis 12X

Yersinia nosode 14X

Inactive Ingredients

40% ethanol, purified water.


Structured Label Content

Label (LABEL)

Est 1985

Professional Formulas

Complementary Health

Intestinal Nosode 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)

Do not use for more than 30 days. Persistent symptoms may be a sign of a serious condition. If symptoms persist or are accompanied by a fever, rash, or persistent headache, 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 to 15 drops once weekly or monthly. If mild symptoms are present, 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 diarrhea, nausea or vomiting, minor abdominal pain or cramping, occasional headache, or lethargy.*

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)

Colchicum autumnale 4X

Aloe 6X

Colocynthis 6X

Nux vomica 6X

Campylobacter 12X

Cholera 12X

Mercurius corrosivus 12X

Shigella 12X

Thermobacter intestinalis 12X

Yersinia nosode 14X

Inactive Ingredients (INACTIVE INGREDIENTS)

40% ethanol, purified water.


Advanced Ingredient Data


Raw Label Data

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