c153

c153
SPL v1
SPL
SPL Set ID 9e8b60e9-0bd7-4c6c-99fa-cb87a9c83172
Route
oral
Published
Effective Date 2019-10-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

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

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


Medication Information

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.

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.

Other Information

Tamper resistant. If seal is broken, do not use. After opening, close container tightly and store at room temperature away from heat.

Inactive Ingredients

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

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.

Questions

Professional Formulas

PO Box 2034 Lake Oswego, OR 97035

Indications

For the temporary relief of minor earache or ringing in the ears.*

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


Structured Label Content

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.

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.

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.

Inactive Ingredients (INACTIVE INGREDIENTS)

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

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.

Questions (QUESTIONS)

Professional Formulas

PO Box 2034 Lake Oswego, OR 97035

Indications (INDICATIONS)

For the temporary relief of minor earache or ringing in the ears.*

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


Advanced Ingredient Data


Raw Label Data

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