EAR DISCOMFORT (aconitum napellus, anthracinum, arnica montana, baptisia tinctoria, capsicum annuum, chamomilla, chenopodium anthelminticum, euphorbium officinarum, lachesis mutus, magnesia mutus, magnesia phosphorica, mercurius corrosivus, plantago major, pulsatilla- vulgaris, verbascum thapsus liquid

Ear Discomfort by

Drug Labeling and Warnings

Ear Discomfort by is a Homeopathic medication manufactured, distributed, or labeled by Liddell Laboratories, Inc., Apotheca Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS:

Aconitum Napellus 200C, Anthracinum 200C, Arnica Montana 200C, Baptisia Tinctoria 3X, Capsicum Annuum 6X, Chamomilla 3X, Chenopodium Anthelminticum 6X, Euphorbium Officinarum 6X, Lachesis Mutus 200C, Magnesia Phosphorica 8X, Mercurius Corrosivus 200C, Plantago Major 3X, Pulsatilla (Vulgaris) 30X, Verbascum Thapsus 3X.

INDICATIONS:

May temporarily relieve symptoms of clogging: pressure, sensitivity, or discomfort of the ear.**

**These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

WARNINGS:

Stop use and ask a doctor if symptoms persist, there is discharge from the ear, or there is a fever.

If pregnant or breast feeding, ask a doctor before use.

Keep out of reach of children. In case of overdose, get medical help or call a Poison Control Center right away.

Do not use if TAMPER EVIDENT seal around neck of bottle is missing or broken.

KEEP OUT OF REACH OF CHILDREN:

Keep out of reach of children. In case of overdose, get medical help or call a Poison Control Center right away.

DIRECTIONS:

Adults and children over 12: Place 15 drops under the tongue up to six times per day until symptoms are relieved.

Children 12 and under: Consult a doctor prior to use.

INDICATIONS:

May temporarily relieve symptoms of clogging: pressure, sensitivity, or discomfort of the ear.**

**These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

INACTIVE INGREDIENTS:

Organic alcohol 20% v/v, Purified water.

QUESTIONS:

DIST. BY LIDDELL LABORATORIES INC.

WOODBINE, IA 51579

WWW.LIDDELL.NET 1-800-460-7733

PACKAGE LABEL DISPLAY:

ORAL SPRAYS

LIDDELL LABORATORIES

EST. 1994

26 Erd
Ear Discomfort

HOMEOPATHIC

1.0 FL. OZ. (30ml)

INGREDIENTS AND APPEARANCE

EAR DISCOMFORT 
aconitum napellus, anthracinum, arnica montana, baptisia tinctoria, capsicum annuum, chamomilla, chenopodium anthelminticum, euphorbium officinarum, lachesis mutus, magnesia mutus, magnesia phosphorica, mercurius corrosivus, plantago major, pulsatilla (vulgaris), verbascum thapsus liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50845-0235
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD)	ACONITUM NAPELLUS	200 [hp_C]  in 1 mL
BACILLUS ANTHRACIS IMMUNOSERUM RABBIT (UNII: 41LZ22DD4N) (BACILLUS ANTHRACIS IMMUNOSERUM RABBIT - UNII:41LZ22DD4N)	BACILLUS ANTHRACIS IMMUNOSERUM RABBIT	200 [hp_C]  in 1 mL
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)	ARNICA MONTANA	200 [hp_C]  in 1 mL
BAPTISIA TINCTORIA ROOT (UNII: 5EF0HWI5WU) (BAPTISIA TINCTORIA ROOT - UNII:5EF0HWI5WU)	BAPTISIA TINCTORIA ROOT	3 [hp_X]  in 1 mL
CAPSICUM (UNII: 00UK7646FG) (CAPSICUM - UNII:00UK7646FG)	CAPSICUM	6 [hp_X]  in 1 mL
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ)	MATRICARIA RECUTITA	3 [hp_X]  in 1 mL
DYSPHANIA AMBROSIOIDES (UNII: 4H5RSU087I) (CHENOPODIUM AMBROSIOIDES - UNII:4H5RSU087I)	DYSPHANIA AMBROSIOIDES	6 [hp_X]  in 1 mL
EUPHORBIA RESINIFERA RESIN (UNII: 1TI1O9028K) (EUPHORBIA RESINIFERA RESIN - UNII:1TI1O9028K)	EUPHORBIA RESINIFERA RESIN	6 [hp_X]  in 1 mL
LACHESIS MUTA VENOM (UNII: VSW71SS07I) (LACHESIS MUTA VENOM - UNII:VSW71SS07I)	LACHESIS MUTA VENOM	200 [hp_C]  in 1 mL
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE	10 [hp_X]  in 1 mL
MERCURIC CHLORIDE (UNII: 53GH7MZT1R) (MERCURIC CATION - UNII:ED30FJ8Y42)	MERCURIC CHLORIDE	200 [hp_C]  in 1 mL
PLANTAGO MAJOR (UNII: W2469WNO6U) (PLANTAGO MAJOR - UNII:W2469WNO6U)	PLANTAGO MAJOR	3 [hp_X]  in 1 mL
PULSATILLA VULGARIS (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV)	PULSATILLA VULGARIS	30 [hp_X]  in 1 mL
VERBASCUM THAPSUS (UNII: C9TD27U172) (VERBASCUM THAPSUS - UNII:C9TD27U172)	VERBASCUM THAPSUS	3 [hp_X]  in 1 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50845-0235-1	30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	01/18/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		01/18/2018

Labeler - Liddell Laboratories, Inc. (832264241)

Registrant - Apotheca Company (844330915)

Establishment
Name	Address	ID/FEI	Business Operations
Apotheca Company		844330915	manufacture(50845-0235) , api manufacture(50845-0235) , label(50845-0235) , pack(50845-0235)