C94

C94
SPL v1
SPL
SPL Set ID 92cfc484-e3bc-4f04-a06a-3299c8522e32
Route
ORAL
Published
Effective Date 2019-10-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Glycyrrhiza Glabra (2 [hp_X]) Phosphate Ion (5 [hp_X]) Starch, Rice (6 [hp_X]) Panicum Miliaceum Whole (12 [hp_X]) Plantago Lanceolata Leaf (30 [hp_X]) Fu Ling Daikon Black Mustard Seed Elymus Repens Root Ginger Goldenseal Activated Charcoal Comfrey Root Arsenic Cation (3+) Helicobacter Pylori
Inactive Ingredients
Alcohol Water

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 1984-08-15

Description

Glycyrrhiza glabra 2X Natrum phosphoricum 2X Oryza sativa 2X Panicum miliaceum 2X Plantago lanceolata 2X Poria 2X Raphanus sativus 2X Sinapis nigra 2X Triticum repens 2X Zingiber officinale 2X Hydrastis canadensis 5X Carbo vegetabilis 6X Symphytum officinale 6X Arsenicum album 12X Helicobacter pylori 30X


Medication Information

Description

Glycyrrhiza glabra 2X Natrum phosphoricum 2X Oryza sativa 2X Panicum miliaceum 2X Plantago lanceolata 2X Poria 2X Raphanus sativus 2X Sinapis nigra 2X Triticum repens 2X Zingiber officinale 2X Hydrastis canadensis 5X Carbo vegetabilis 6X Symphytum officinale 6X Arsenicum album 12X Helicobacter pylori 30X

Label

Est 1985

Professional Formulas

Complementary Health

Ulcer 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

Severe or persistent symptoms may be a sign of a serious condition. Consult a doctor promptly if symptoms persist or are accompanied by a fever, vomiting, diarrhea, or loss of appetite. 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 temporary relief of minor pain in the upper abdomen, heartburn, indigestion, flatulence, or nausea.*

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

Glycyrrhiza glabra 2X

Natrum phosphoricum 2X

Oryza sativa 2X

Panicum miliaceum 2X

Plantago lanceolata 2X

Poria 2X

Raphanus sativus 2X

Sinapis nigra 2X

Triticum repens 2X

Zingiber officinale 2X

Hydrastis canadensis 5X

Carbo vegetabilis 6X

Symphytum officinale 6X

Arsenicum album 12X

Helicobacter pylori 30X

Inactive Ingredients

10% ethanol, purified water, 8% vegetable glycerin (from soy).


Structured Label Content

Label (LABEL)

Est 1985

Professional Formulas

Complementary Health

Ulcer 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)

Severe or persistent symptoms may be a sign of a serious condition. Consult a doctor promptly if symptoms persist or are accompanied by a fever, vomiting, diarrhea, or loss of appetite. 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 temporary relief of minor pain in the upper abdomen, heartburn, indigestion, flatulence, or nausea.*

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)

Glycyrrhiza glabra 2X

Natrum phosphoricum 2X

Oryza sativa 2X

Panicum miliaceum 2X

Plantago lanceolata 2X

Poria 2X

Raphanus sativus 2X

Sinapis nigra 2X

Triticum repens 2X

Zingiber officinale 2X

Hydrastis canadensis 5X

Carbo vegetabilis 6X

Symphytum officinale 6X

Arsenicum album 12X

Helicobacter pylori 30X

Inactive Ingredients (INACTIVE INGREDIENTS)

10% ethanol, purified water, 8% vegetable glycerin (from soy).


Advanced Ingredient Data


Raw Label Data

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