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

QUESTIONS

Professional Formulas

PO Box 2034 Lake Oswego, OR 97035

INDICATIONS

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

*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.

Keep out of the reach of children.

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).

LABEL

Est 1985

Professional Formulas

Complementary Health

Otitis Media Drops

Homeopathic Remedy

2 FL. OZ. (59 mL)

OTITIS MEDIA DROPS 2153
otitis media drops liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63083-2153
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I)	OYSTER SHELL CALCIUM CARBONATE, CRUDE	3 [hp_X] in 59 mL
PULSATILLA MONTANA WHOLE (UNII: 24K790T39B) (PULSATILLA MONTANA WHOLE - UNII:24K790T39B)	PULSATILLA MONTANA WHOLE	4 [hp_X] in 59 mL
ACONITUM NAPELLUS WHOLE (UNII: U0NQ8555JD) (ACONITUM NAPELLUS WHOLE - UNII:U0NQ8555JD)	ACONITUM NAPELLUS WHOLE	6 [hp_X] in 59 mL
SUS SCROFA EAR (UNII: 7DX2J287CV) (SUS SCROFA EAR - UNII:7DX2J287CV)	SUS SCROFA EAR	6 [hp_X] in 59 mL
AMARYLLIS BELLADONNA WHOLE (UNII: 11B89M58UN) (AMARYLLIS BELLADONNA WHOLE - UNII:11B89M58UN)	AMARYLLIS BELLADONNA WHOLE	12 [hp_X] in 59 mL
TELLURIUM (UNII: NQA0O090ZJ) (TELLURIUM - UNII:NQA0O090ZJ)	TELLURIUM	12 [hp_X] in 59 mL
FERROSOFERRIC PHOSPHATE (UNII: 91GQH8I5F7) (FERROSOFERRIC PHOSPHATE - UNII:91GQH8I5F7)	FERROSOFERRIC PHOSPHATE	12 [hp_X] in 59 mL
GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q)	GELSEMIUM SEMPERVIRENS ROOT	30 [hp_X] in 59 mL
MERCURY (UNII: FXS1BY2PGL) (MERCURY - UNII:FXS1BY2PGL)	MERCURY	30 [hp_X] in 59 mL
STREPTOCOCCUS PNEUMONIAE (UNII: BT6U234YR2) (STREPTOCOCCUS PNEUMONIAE - UNII:BT6U234YR2)	STREPTOCOCCUS PNEUMONIAE	30 [hp_X] in 59 mL
HAEMOPHILUS INFLUENZAE (UNII: K738E2MB3I) (HAEMOPHILUS INFLUENZAE - UNII:K738E2MB3I)	HAEMOPHILUS INFLUENZAE	60 [hp_X] in 59 mL

Ingredient Name	Strength
Inactive Ingredients
ALCOHOL (UNII: 3K9958V90M)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63083-2153-2	59 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	08/15/1985

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		08/15/1984

Labeler - Professional Complementary Health Formulas (167339027)

Registrant - Natural Pharmaceutical Manufacturing LLC (015624923)

Name	Address	ID/FEI	Business Operations
Establishment
Natural Pharmaceutical Manufacturing LLC		015624923	manufacture(63083-2153)

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