N17

N17
SPL v1
SPL
SPL Set ID da9145a5-42e9-4dba-9d11-195848e628a4
Route
ORAL
Published
Effective Date 2019-10-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
House Dust (12 [hp_X]) Stachybotrys Chartarum (30 [hp_X]) Medicago Sativa Whole (6 [hp_X]) Fraxinus Latifolia Whole Taraxacum Officinale Dichromate Ion Calcium Sulfide Histamine Silicon Dioxide Guaiac Luffa Operculata Fruit
Inactive Ingredients
Alcohol Water

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 1984-08-15

Description

House dust mix 12X (15% by volume) Mold mix 12X (15% by volume) Grass mix 12X (10% by volume) Tree mix 12X (10% by volume) Weed mix 12X (10% by volume) Kali bichromicum 30X (5% by volume) Hepar sulphuris calcareum 12X (5% by volume) Histaminum 12X (5% by volume) Silicea 12X (5% by volume) Euphorbium officinalis 6X (5% by volume) Guaiacum 6X (5% by volume) Luffa operculata 6X (5% by volume) Sinapsis nigra 3X (5% by volume)


Medication Information

Description

House dust mix 12X (15% by volume) Mold mix 12X (15% by volume) Grass mix 12X (10% by volume) Tree mix 12X (10% by volume) Weed mix 12X (10% by volume) Kali bichromicum 30X (5% by volume) Hepar sulphuris calcareum 12X (5% by volume) Histaminum 12X (5% by volume) Silicea 12X (5% by volume) Euphorbium officinalis 6X (5% by volume) Guaiacum 6X (5% by volume) Luffa operculata 6X (5% by volume) Sinapsis nigra 3X (5% by volume)

Label

Est 1985

Professional Formulas

Complementary Health

Allergy Nosode

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

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 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 runny nose, nasal congestion, headache, itchy or watery eyes, or mild facial or ear pain due to 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

House dust mix 12X (15% by volume)

Mold mix 12X (15% by volume)

Grass mix 12X (10% by volume)

Tree mix 12X (10% by volume)

Weed mix 12X (10% by volume)

Kali bichromicum 30X (5% by volume)

Hepar sulphuris calcareum 12X (5% by volume)

Histaminum 12X (5% by volume)

Silicea 12X (5% by volume)

Euphorbium officinalis 6X (5% by volume)

Guaiacum 6X (5% by volume)

Luffa operculata 6X (5% by volume)

Sinapsis nigra 3X (5% by volume)

Inactive Ingredients

20% ethanol, purified water.


Structured Label Content

Label (LABEL)

Est 1985

Professional Formulas

Complementary Health

Allergy Nosode

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)

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 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 runny nose, nasal congestion, headache, itchy or watery eyes, or mild facial or ear pain due to 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)

House dust mix 12X (15% by volume)

Mold mix 12X (15% by volume)

Grass mix 12X (10% by volume)

Tree mix 12X (10% by volume)

Weed mix 12X (10% by volume)

Kali bichromicum 30X (5% by volume)

Hepar sulphuris calcareum 12X (5% by volume)

Histaminum 12X (5% by volume)

Silicea 12X (5% by volume)

Euphorbium officinalis 6X (5% by volume)

Guaiacum 6X (5% by volume)

Luffa operculata 6X (5% by volume)

Sinapsis nigra 3X (5% by volume)

Inactive Ingredients (INACTIVE INGREDIENTS)

20% ethanol, purified water.


Advanced Ingredient Data


Raw Label Data

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