R412

R412
SPL v1
SPL
SPL Set ID af758440-624f-4844-9477-2eda7131ae07
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 Lactobacillus Acidophilus Enterobacter Aerogenes Enterococcus Faecium Escherichia Coli Klebsiella Pneumoniae Mercuric Cation
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 Acidophilus 12X Aerobacter 12X Enterococcinum 12X Escherichia coli 12X Klebsiella 12X Mercurius corrosivus 12X


Medication Information

Description

Colchicum autumnale 4X Aloe 6X Colocynthis 6X Nux vomica 6X Acidophilus 12X Aerobacter 12X Enterococcinum 12X Escherichia coli 12X Klebsiella 12X Mercurius corrosivus 12X

Label

Est 1985

Professional Formulas

Complementary Health

Normal Intestinal Flora 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 bloating, abdominal pain or discomfort, diarrhea, fatigue, or weakness.*

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

Acidophilus 12X

Aerobacter 12X

Enterococcinum 12X

Escherichia coli 12X

Klebsiella 12X

Mercurius corrosivus 12X

Inactive Ingredients

40% ethanol, purified water.


Structured Label Content

Label (LABEL)

Est 1985

Professional Formulas

Complementary Health

Normal Intestinal Flora 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 bloating, abdominal pain or discomfort, diarrhea, fatigue, or weakness.*

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

Acidophilus 12X

Aerobacter 12X

Enterococcinum 12X

Escherichia coli 12X

Klebsiella 12X

Mercurius corrosivus 12X

Inactive Ingredients (INACTIVE INGREDIENTS)

40% ethanol, purified water.


Advanced Ingredient Data


Raw Label Data

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