R255

R255
SPL v1
SPL
SPL Set ID ff642588-439e-4e79-8c7b-3d388938eca5
Route
ORAL
Published
Effective Date 2019-10-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Plantago Major Whole (3 [hp_X]) Pulsatilla Montana Whole (4 [hp_X]) Euphorbia Resinifera Resin (6 [hp_X]) Luffa Operculata Fruit (8 [hp_X]) Mercuric Iodide (10 [hp_X]) Sus Scrofa Nasal Mucosa (12 [hp_X]) Silver Cation (30 [hp_X]) Calcium Sulfide Sinusitisinum Diphtherial Respiratory Pseudomembrane Human
Inactive Ingredients
Alcohol Water

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 1984-08-15

Description

Plantago major 3X Pulsatilla 4X Euphorbium officinarum 6X Luffa operculata 6X Mercurius iodatus ruber 8X Mucosa nasalis 8X Argentum nitricum 10X Hepar sulphuris calcareum 10X Sinusitis 12X Diphtherinum 30X


Medication Information

Description

Plantago major 3X Pulsatilla 4X Euphorbium officinarum 6X Luffa operculata 6X Mercurius iodatus ruber 8X Mucosa nasalis 8X Argentum nitricum 10X Hepar sulphuris calcareum 10X Sinusitis 12X Diphtherinum 30X

Label

Est 1985

Professional Formulas

Complementary Health

Euphorbium 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

If symptoms do not improve or are accompanied by a fever, 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 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 runny nose, nasal congestion, headache, or mild facial or ear pain due to a cold, hay fever, or other upper respiratory allergies.*

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

Plantago major 3X

Pulsatilla 4X

Euphorbium officinarum 6X

Luffa operculata 6X

Mercurius iodatus ruber 8X

Mucosa nasalis 8X

Argentum nitricum 10X

Hepar sulphuris calcareum 10X

Sinusitis 12X

Diphtherinum 30X

Inactive Ingredients

40% ethanol, purified water.


Structured Label Content

Label (LABEL)

Est 1985

Professional Formulas

Complementary Health

Euphorbium 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)

If symptoms do not improve or are accompanied by a fever, 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 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 runny nose, nasal congestion, headache, or mild facial or ear pain due to a cold, hay fever, or other upper respiratory allergies.*

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)

Plantago major 3X

Pulsatilla 4X

Euphorbium officinarum 6X

Luffa operculata 6X

Mercurius iodatus ruber 8X

Mucosa nasalis 8X

Argentum nitricum 10X

Hepar sulphuris calcareum 10X

Sinusitis 12X

Diphtherinum 30X

Inactive Ingredients (INACTIVE INGREDIENTS)

40% ethanol, purified water.


Advanced Ingredient Data


Raw Label Data

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