R418

R418
SPL v1
SPL
SPL Set ID 9981ec07-9bda-4789-9061-9e89de9ee8ed
Route
ORAL
Published
Effective Date 2019-10-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aconitum Napellus Whole (4 [hp_X]) Bryonia Alba Root (5 [hp_X]) Phosphorus (6 [hp_X]) Wood Creosote (12 [hp_X]) Listeria Monocytogenes Staphylococcus Aureus Streptococcus Pyogenes
Inactive Ingredients
Alcohol Water

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 1984-08-15

Description

Aconitum napellus 4X Bryonia 4X Phosphorus 5X Kreosotum 6X Listeriosis 12X Staphylococcus aureus 12X Streptococcus hemolyticus 12X Streptococcus viridans 12X


Medication Information

Description

Aconitum napellus 4X Bryonia 4X Phosphorus 5X Kreosotum 6X Listeriosis 12X Staphylococcus aureus 12X Streptococcus hemolyticus 12X Streptococcus viridans 12X

Label

Est 1985

Professional Formulas

Complementary Health

Staph/Strep/Respiratory 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

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 runny nose, nasal congestion, sneezing, sore or scratchy throat, or coughing.*

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

Aconitum napellus 4X

Bryonia 4X

Phosphorus 5X

Kreosotum 6X

Listeriosis 12X

Staphylococcus aureus 12X

Streptococcus hemolyticus 12X

Streptococcus viridans 12X

Inactive Ingredients

40% ethanol, purified water.


Structured Label Content

Label (LABEL)

Est 1985

Professional Formulas

Complementary Health

Staph/Strep/Respiratory 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)

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 runny nose, nasal congestion, sneezing, sore or scratchy throat, or coughing.*

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)

Aconitum napellus 4X

Bryonia 4X

Phosphorus 5X

Kreosotum 6X

Listeriosis 12X

Staphylococcus aureus 12X

Streptococcus hemolyticus 12X

Streptococcus viridans 12X

Inactive Ingredients (INACTIVE INGREDIENTS)

40% ethanol, purified water.


Advanced Ingredient Data


Raw Label Data

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