4 Kids Earache Relief

Manufacturer: Hyland's Inc.
Effective date: 2022-11-22
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: legacy-cache
Hydrated at: 2026-08-01 21:46:30

Label at a glance#

Product4 Kids Earache Relief

Active ingredientMATRICARIA CHAMOMILLA, FERROSOFERRIC PHOSPHATE, LYCOPODIUM CLAVATUM SPORE, ANEMONE PULSATILLA, OYSTER SHELL CALCIUM CARBONATE, CRUDE, SULFUR

Label structure7 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

Children 2 years to under 6 years Dissolve 2 tablets under tongue every 8 hours until relieved for up to 48 hours. Children 6 years to under 12 years Dissolve 3 tablets under tongue every 8 hours until relieved for up to 48 hours. Adults and children 12 years and over Dissolve 4 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

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Calcarea Carbonica 30C HPUS

Chamomilla 30C HPUS

Ferrum Phosphoricum 30C HPUS

Lycopodium 30C HPUS

Pulsatilla 30C HPUS

Sulphur 30C HPUS

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

Pharmacopœia of the United States.

Purpose

OTC - PURPOSE SECTION

Calcarea Carbonica 30C HPUS.....................................................throbbing ear pain

Chamomilla 30C HPUS ...............................occasional sleeplessness and irritability

Ferrum Phosphoricum 30C HPUS...........................................................minor fever

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

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

Consult a physician if

SPL UNCLASSIFIED SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all medications out of reach of children. In case of accidental overdose, contact a medical professional or Poison Control Center immediately.

OTC - DO NOT USE SECTION

Do not use if imprinted tamper-evident bottle cap band is broken or missing.

The inner packaged bottle is child resistant.

SPL UNCLASSIFIED SECTION

In case of emergency

SPL UNCLASSIFIED SECTION

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

Children 2 years

to under 6 years

Dissolve 2 tablets under tongue every 8 hours

until relieved for up to 48 hours.

Children 6 years

to under 12 years

Dissolve 3 tablets under tongue every 8 hours

until relieved for up to 48 hours.

Adults and children

12 years and over

Dissolve 4 tablets under tongue every 8 hours

until relieved for up to 48 hours.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Acacia Gum, Lactose.

Questions or comments?

OTC - QUESTIONS SECTION

(800) 624-9659

Principal Display Panel - 40 Tablets Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

New!

NDC 54973-3393-1

HOMEOPATHIC

Ages

2-12

NATURAL

RELIEF

SINCE 1903

Hyland's

4 Kids

Earache Relief*

Ear Pain

Fever

Irritability

40 QUICK-DISSOLVING TABLETS

ACTUAL SIZE 194 MG

carton

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

4 Kids Earache Relief
MATRICARIA CHAMOMILLA,FERRIC PHOSPHATE,SULFUR,OYSTER SHELL CALCIUM CARBONATE, CRUDE,LYCOPODIUM CLAVATUM SPORE and ANEMONE PULSATILLA
ACACIA
LACTOSE MONOHYDRATE
ANHYDROUS LACTOSE
MATRICARIA CHAMOMILLA
FERROSOFERRIC PHOSPHATE
LYCOPODIUM CLAVATUM SPORE
ANEMONE PULSATILLA
OYSTER SHELL CALCIUM CARBONATE, CRUDE
SULFUR

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
54973-3393	54973-3393-1

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
FERROSOFERRIC PHOSPHATE	91GQH8I5F7	ACTIB
LYCOPODIUM CLAVATUM SPORE	C88X29Y479	ACTIB
ANEMONE PULSATILLA	I76KB35JEV	ACTIB
OYSTER SHELL CALCIUM CARBONATE, CRUDE	2E32821G6I	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
32d972ad-555a-e662-e063-6294a90afb3b			7a7facbe-f245-d991-e053-2a91aa0aa26f	2025-04-15	Warnings	Exact identifier spl set id: 7a7facbe-f245-d991-e053-2a91aa0aa26f

Reported adverse events (FAERS/openFDA)#

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