C153

Drug Facts

Composition & Product

Active Ingredients

Oyster Shell Calcium Carbonate, Crude (3 [hp_X]) Pulsatilla Montana Whole (4 [hp_X]) Aconitum Napellus Whole (6 [hp_X]) Sus Scrofa Ear (12 [hp_X]) Amaryllis Belladonna Whole (30 [hp_X]) Tellurium (60 [hp_X]) Ferrosoferric Phosphate Gelsemium Sempervirens Root Mercury Streptococcus Pneumoniae Haemophilus Influenzae

Inactive Ingredients

Alcohol Water

Identifiers & Packaging

Marketing Status

UNAPPROVED HOMEOPATHIC Active Since 1984-08-15

Medication Information

Description

Calcarea carbonica 3X Pulsatilla 4X, 12X, 30X Aconitum napellus 6X Ear 6X, 60X, 100X, 200X Belladonna 12X Tellurium metallicum 12X Ferrum phosphoricum 12X, 30X Gelsemium sempervirens 30X Mercurius vivus 30X Streptococcus pneumoniae 30X Haemophilus influenzae 60X

Label

Est 1985

Professional Formulas

Complementary Health

Otitis Media 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

Persistent symptoms may be a sign of a serious condition. If symptoms persist or are accompanied by a fever, persistent headache, or loss of hearing, 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 minor earache or ringing in the ears.*

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

Calcarea carbonica 3X

Pulsatilla 4X, 12X, 30X

Aconitum napellus 6X

Ear 6X, 60X, 100X, 200X

Belladonna 12X

Tellurium metallicum 12X

Ferrum phosphoricum 12X, 30X

Gelsemium sempervirens 30X

Mercurius vivus 30X

Streptococcus pneumoniae 30X

Haemophilus influenzae 60X

Inactive Ingredients

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

Structured Label Content

Label (LABEL)

Est 1985

Professional Formulas

Complementary Health

Otitis Media 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)

Persistent symptoms may be a sign of a serious condition. If symptoms persist or are accompanied by a fever, persistent headache, or loss of hearing, 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 minor earache or ringing in the ears.*

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)

Calcarea carbonica 3X

Pulsatilla 4X, 12X, 30X

Aconitum napellus 6X

Ear 6X, 60X, 100X, 200X

Belladonna 12X

Tellurium metallicum 12X

Ferrum phosphoricum 12X, 30X

Gelsemium sempervirens 30X

Mercurius vivus 30X

Streptococcus pneumoniae 30X

Haemophilus influenzae 60X

Inactive Ingredients (INACTIVE INGREDIENTS)

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

Advanced Ingredient Data

[{"name": "OYSTER SHELL CALCIUM CARBONATE, CRUDE", "unii": "2E32821G6I", "classCode": "ACTIB", "strengthNumerator": "3", "strengthDenominator": "59", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "PULSATILLA MONTANA WHOLE", "unii": "24K790T39B", "classCode": "ACTIB", "strengthNumerator": "4", "strengthDenominator": "59", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "ACONITUM NAPELLUS WHOLE", "unii": "U0NQ8555JD", "classCode": "ACTIB", "strengthNumerator": "6", "strengthDenominator": "59", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "SUS SCROFA EAR", "unii": "7DX2J287CV", "classCode": "ACTIB", "strengthNumerator": "6", "strengthDenominator": "59", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "AMARYLLIS BELLADONNA WHOLE", "unii": "11B89M58UN", "classCode": "ACTIB", "strengthNumerator": "12", "strengthDenominator": "59", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "TELLURIUM", "unii": "NQA0O090ZJ", "classCode": "ACTIB", "strengthNumerator": "12", "strengthDenominator": "59", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "FERROSOFERRIC PHOSPHATE", "unii": "91GQH8I5F7", "classCode": "ACTIB", "strengthNumerator": "12", "strengthDenominator": "59", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "GELSEMIUM SEMPERVIRENS ROOT", "unii": "639KR60Q1Q", "classCode": "ACTIB", "strengthNumerator": "30", "strengthDenominator": "59", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "MERCURY", "unii": "FXS1BY2PGL", "classCode": "ACTIB", "strengthNumerator": "30", "strengthDenominator": "59", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "STREPTOCOCCUS PNEUMONIAE", "unii": "BT6U234YR2", "classCode": "ACTIB", "strengthNumerator": "30", "strengthDenominator": "59", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "HAEMOPHILUS INFLUENZAE", "unii": "K738E2MB3I", "classCode": "ACTIB", "strengthNumerator": "60", "strengthDenominator": "59", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"LABEL": "Est 1985 Professional Formulas Complementary Health Otitis Media Drops Homeopathic Remedy 2 FL. OZ. (59 mL)", "50565-1": "Keep out of the reach of children.", "53414-9": "If pregnant or breastfeeding, ask a healthcare professional before use.", "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, persistent headache, or loss of hearing, 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 minor earache or ringing in the ears.*", "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": "Calcarea carbonica 3X Pulsatilla 4X, 12X, 30X Aconitum napellus 6X Ear 6X, 60X, 100X, 200X Belladonna 12X Tellurium metallicum 12X Ferrum phosphoricum 12X, 30X Gelsemium sempervirens 30X Mercurius vivus 30X Streptococcus pneumoniae 30X Haemophilus influenzae 60X", "INACTIVE INGREDIENTS": "10% ethanol, purified water, 8% vegetable glycerin (from soy)."}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information