EAR DISCOMFORT (aconitum napellus, anthracinum, arnica montana, baptisia tinctoria, belladonna, capsicum annuum, chamomilla, chenopodium anthelminticum, euphorbium officinarum, lachesis mutus, magnesia phosphorica, plantago major, pulsatilla- pratensis, 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:

(in each drop) 7.14% of Aconitum Napellus 200C, Anthracinum 200C, Arnica Montana 200C, Baptisia Tinctoria 3X, Belladonna 200C, Capsicum Annuum 6X, Chamomilla 3X, Chenopodium Anthelminticum 15X, Euphorbium Officinarum 6X, Lachesis Mutus 200C, Magnesia Phosphorica 10X, Plantago Major 3X, Pulsatilla (Pratensis) 30X, Verbascum Thapsus 6X.

INDICATIONS:

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

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

WARNINGS:

Stop use and ask a doctor if symptoms persist for more than 4 days, 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.**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

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, belladonna, capsicum annuum, chamomilla, chenopodium anthelminticum, euphorbium officinarum, lachesis mutus, magnesia phosphorica, plantago major, pulsatilla (pratensis), verbascum thapsus liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50845-0259
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
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H)	ATROPA BELLADONNA	200 [hp_C]  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 WHOLE (UNII: 4H5RSU087I) (CHENOPODIUM AMBROSIOIDES - UNII:4H5RSU087I)	DYSPHANIA AMBROSIOIDES WHOLE	15 [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
PLANTAGO MAJOR (UNII: W2469WNO6U) (PLANTAGO MAJOR - UNII:W2469WNO6U)	PLANTAGO MAJOR	3 [hp_X]  in 1 mL
ANEMONE PRATENSIS (UNII: 8E272251DI) (ANEMONE PRATENSIS - UNII:8E272251DI)	ANEMONE PRATENSIS	30 [hp_X]  in 1 mL
VERBASCUM THAPSUS (UNII: C9TD27U172) (VERBASCUM THAPSUS - UNII:C9TD27U172)	VERBASCUM THAPSUS	6 [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: 50845-0259-1	30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	03/09/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		03/09/2020

Labeler - Liddell Laboratories, Inc. (832264241)

Registrant - Apotheca Company (844330915)

Establishment
Name	Address	ID/FEI	Business Operations
Apotheca Company		844330915	manufacture(50845-0259) , api manufacture(50845-0259) , label(50845-0259) , pack(50845-0259)