x46

x46
SPL v1
SPL
SPL Set ID eebc5855-30e0-4866-83dc-8700f995fa49
Route
oral
Published
Effective Date 2019-10-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
chelidonium majus whole (3 [hp_X]) artemisia cina pre-flowering top (4 [hp_X]) eucalyptus globulus leaf (6 [hp_X]) dryopteris filix-mas root (8 [hp_X]) garlic (12 [hp_X]) antimony cation (3+) (30 [hp_X]) wormwood taraxacum officinale flowering top bos taurus large intestine ipecac beef liver beef lung spigelia marilandica root ammonium cation arsenic cation (3+) lytta vesicatoria blastocystis hominis cryptosporidium hominis dientamoeba fragilis entamoeba histolytica giardia lamblia plasmodium knowlesi toxoplasma gondii trichomonas vaginalis
Inactive Ingredients
alcohol water

Identifiers & Packaging

Marketing Status
unapproved homeopathic active Since 1984-08-15

Description

Chelidonium majus 3X Cina 3X Eucalyptus globulus 3X Filix mas 4X Allium sativum 6X Antimonium tartaricum 6X Artemisia absinthium 6X Herbal bitters 6X Intestines (small and large) 6X Ipecacuanha 6X Liver 6X Lung 6X Spigelia marilandica 6X Ammonium phosphoricum 6X, 12X Arsenicum album 8X Cantharis 12X and all the following at 30X, 60X, 100X: Blastocystis hominis Cryptosporidium Dientamoeba fragilis Endolimax nana Entamoeba histolytica Giardia lamblia Plasmodium Toxoplasmosis Trichomonas vaginalis


Medication Information

Warnings

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.

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.

Other Information

Tamper resistant. If seal is broken, do not use. After opening, close container tightly and store at room temperature away from heat.

Inactive Ingredients

20% ethanol, purified water.

Description

Chelidonium majus 3X Cina 3X Eucalyptus globulus 3X Filix mas 4X Allium sativum 6X Antimonium tartaricum 6X Artemisia absinthium 6X Herbal bitters 6X Intestines (small and large) 6X Ipecacuanha 6X Liver 6X Lung 6X Spigelia marilandica 6X Ammonium phosphoricum 6X, 12X Arsenicum album 8X Cantharis 12X and all the following at 30X, 60X, 100X: Blastocystis hominis Cryptosporidium Dientamoeba fragilis Endolimax nana Entamoeba histolytica Giardia lamblia Plasmodium Toxoplasmosis Trichomonas vaginalis

Label

Est 1985

Professional Formulas

Complementary Health

Amoeba/Protozoan Detox

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.

Questions

Professional Formulas

PO Box 2034 Lake Oswego, OR 97035

Indications

For the temporary relief of mild abdominal pain, diarrhea, bloating, nausea or vomiting, indigestion, occasional headache, muscle aches or pains, fatigue, or feelings of discomfort or uneasiness.*

Active Ingredients

Chelidonium majus 3X

Cina 3X

Eucalyptus globulus 3X

Filix mas 4X

Allium sativum 6X

Antimonium tartaricum 6X

Artemisia absinthium 6X

Herbal bitters 6X

Intestines (small and large) 6X

Ipecacuanha 6X

Liver 6X

Lung 6X

Spigelia marilandica 6X

Ammonium phosphoricum 6X, 12X

Arsenicum album 8X

Cantharis 12X

and all the following at 30X, 60X, 100X:

Blastocystis hominis

Cryptosporidium

Dientamoeba fragilis

Endolimax nana

Entamoeba histolytica

Giardia lamblia

Plasmodium

Toxoplasmosis

Trichomonas vaginalis


Structured Label Content

Warnings (WARNINGS)

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.

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.

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.

Inactive Ingredients (INACTIVE INGREDIENTS)

20% ethanol, purified water.

Label (LABEL)

Est 1985

Professional Formulas

Complementary Health

Amoeba/Protozoan Detox

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.

Questions (QUESTIONS)

Professional Formulas

PO Box 2034 Lake Oswego, OR 97035

Indications (INDICATIONS)

For the temporary relief of mild abdominal pain, diarrhea, bloating, nausea or vomiting, indigestion, occasional headache, muscle aches or pains, fatigue, or feelings of discomfort or uneasiness.*

Active Ingredients (ACTIVE INGREDIENTS)

Chelidonium majus 3X

Cina 3X

Eucalyptus globulus 3X

Filix mas 4X

Allium sativum 6X

Antimonium tartaricum 6X

Artemisia absinthium 6X

Herbal bitters 6X

Intestines (small and large) 6X

Ipecacuanha 6X

Liver 6X

Lung 6X

Spigelia marilandica 6X

Ammonium phosphoricum 6X, 12X

Arsenicum album 8X

Cantharis 12X

and all the following at 30X, 60X, 100X:

Blastocystis hominis

Cryptosporidium

Dientamoeba fragilis

Endolimax nana

Entamoeba histolytica

Giardia lamblia

Plasmodium

Toxoplasmosis

Trichomonas vaginalis


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)