Hyland's Earache Tablets

Manufacturer: Hyland's | Standard Homeopathic Company
Effective date: 2019-09-13
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: legacy-cache
Hydrated at: 2026-08-02 00:11:57

Label at a glance#

ProductEarache

Active ingredientMATRICARIA CHAMOMILLA, ATROPA BELLADONNA, OYSTER SHELL CALCIUM CARBONATE, CRUDE, LYCOPODIUM CLAVATUM SPORE, PULSATILLA VULGARIS, SULFUR

Label structure11 sections

Indications and uses

Temporarily relieves the symptoms of: minor fever  ear pain or throbbing occasional sleeplessness or irritability associated with earaches after diagnosis by a physician

Dosage and administration

Adults and children 12 years and over Dissolve 2-3 tablets under tongue every 8 hours until relieved for up to 48 hours.

Contacts and useful links#

PhoneLabel contact(800) 624-9659

Label contents#

Full prescribing information#

Drug Facts

SPL UNCLASSIFIED SECTION

OTC - ACTIVE INGREDIENT SECTION

*Active ingredients*	*Purpose*
Belladonna 30C HPUS	minor fever
(less than 0.000000000001% Alkaloids, calculated)
Calcarea Carbonica 30C HPUS	throbbing ear pain
Chamomilla 30C HPUS	occasional sleeplessness and irritability
Lycopodium 30C HPUS	ear pain
Pulsatilla 30C HPUS	ear itching, pain worse at night,minor fever
Sulphur 30C HPUS	ear pain with burning,minor fever

“HPUS” indicates that the active ingredients are in the official

Homeopathic Pharmacopoeia of the United States.

OTC - PURPOSE SECTION

minor fever

throbbing ear pain

occasional sleeplessness and irritability

ear pain

ear itching, pain worse at night, minor fever

ear pain with burning, minor fever

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves the symptoms of:
minor fever 
ear pain or throbbing
occasional sleeplessness or irritability associated with earaches after diagnosis by a physician

Warnings

WARNINGS SECTION

As with any drug, ask a doctor before use if pregnant or breast-feeding.

SPL UNCLASSIFIED SECTION

Do not use more than directed.

SPL UNCLASSIFIED SECTION

Consult a physician if: 

symptoms persist for more than 48 hours or worsen.
discharge from ear is present. 
symptoms are accompanied by a high fever (over 101°F).

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all medications out of the reach of children.

SPL UNCLASSIFIED SECTION

In case of emergency or accidental overdose, contact a medical professional or Poison

Control Center immediately. Hyland’s may also be contacted for emergency information

about our products 24 hours a day, 7 days per week at (800) 624-9659.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children

12 years and over

Dissolve 2-3 tablets under tongue every 8 hours

until relieved for up to 48 hours.

Other information

SPL UNCLASSIFIED SECTION

Do not use if imprinted "SEALED FOR YOUR PROTECTION" tamper-evident

bottle cap band is broken or missing.

The inner packaged bottle is child-resistant.

INACTIVE INGREDIENT SECTION

Acacia Gum, Lactose.

Questions or comments?

OTC - QUESTIONS SECTION

(800) 624-9659

SPL UNCLASSIFIED SECTION

*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE,

NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.

Dosage and Administration "Directions"

RECENT MAJOR CHANGES SECTION

Adults and children

12 years and over

Dissolve 2-3 tablets under tongue every 8 hours

until relieved for up to 48 hours.

Indications and Usage

RECENT MAJOR CHANGES SECTION

Temporarily relieves the symptoms of:
minor fever 
ear pain or throbbing
occasional sleeplessness or irritability associated with earaches after diagnosis by a physician

Principal Display Panel - 40 Tablet Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 54973-3169-1

HOMEOPATHIC

Natural

Relief

SINCE 1903

Hyland's^®

EARACHE

TABLETS

RELIEVES EAR PAIN FAST*

CALMS & SOOTHES

EARACHES DUE TO:

COLD & FLU
ALLERGY
MINOR FEVER

40 QUICK-DISSOLVING TABLETS

ACTUAL SIZE 194 MG

*SEE NOTE ON BACK PANEL

BELOW DRUG FACTS

CARTON

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

Earache
MATRICARIA CHAMOMILLA, ATROPA BELLADONNA, OYSTER SHELL CALCIUM CARBONATE, CRUDE, SULFUR, PULSATILLA VULGARIS and LYCOPODIUM CLAVATUM SPORE
ACACIA
LACTOSE MONOHYDRATE
MATRICARIA CHAMOMILLA
ATROPA BELLADONNA
OYSTER SHELL CALCIUM CARBONATE, CRUDE
LYCOPODIUM CLAVATUM SPORE
PULSATILLA VULGARIS
SULFUR

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
54973-3169	54973-3169-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ACACIA	5C5403N26O	IACT
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
MATRICARIA CHAMOMILLA	G0R4UBI2ZZ	ACTIB
ATROPA BELLADONNA	WQZ3G9PF0H	ACTIB
OYSTER SHELL CALCIUM CARBONATE, CRUDE	2E32821G6I	ACTIB
LYCOPODIUM CLAVATUM SPORE	C88X29Y479	ACTIB
PULSATILLA VULGARIS	I76KB35JEV	ACTIB
SULFUR	70FD1KFU70	ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
d43d4484-9f50-0998-e053-2995a90a0533			56bdf20b-0a8a-4532-e054-00144ff8d46c	2021-12-28	Warnings	Exact identifier spl set id: 56bdf20b-0a8a-4532-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.