4 Kids Earache Relief

Manufacturer
Hyland’s
Effective date
2022-11-22
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 02:18:37

Label at a glance#

Product4 Kids Earache Relief
Active ingredientATROPA BELLADONNA, OYSTER SHELL CALCIUM CARBONATE, CRUDE, MATRICARIA CHAMOMILLA, ANEMONE PULSATILLA, SULFUR, LYCOPODIUM CLAVATUM SPORE
Label structure12 sections

Indications and uses

Temporarily relieves symptoms of earache in children, including: ■ minor fever ■ ear pain or throbbing ■ common pain or itching of "swimmer’s ear" ■ irritability or occasional sleeplessness associated with earaches after diagnosis by a physician

Dosage and administration

■ Shake well before using. Children ages 2 years and over: Tilt head sideways and apply 3-4 drops into involved ear (Tip of applicator should not enter ear canal). Keep head tilted for at least 2 minutes to keep drops in ear. Repeat until relieved, up to 4 times daily.

Label contents#

Full prescribing information#

Purpose

OTC - PURPOSE SECTION

Relieves earache due to swimmer’s ear, cold, flu & allergy

Drug Facts

SPL UNCLASSIFIED SECTION

OTC - ACTIVE INGREDIENT SECTION

Active ingredients

Purpose

Belladonna 30C HPUS

(less than 0.000000000001% Alkaloids, calculated)

minor fever

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

Sulphur 30C HPUS

ear pain with burning

SPL UNCLASSIFIED SECTION

"HPUS" indicates that the active ingredients are in the official Homeopathic Pharmacopœia of the United States.

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves symptoms of earache in children, including: ■ minor fever ■ ear pain or throbbing ■ common pain or

itching of "swimmer’s ear" ■ irritability or occasional sleeplessness associated with earaches after diagnosis by a physician

Warnings

WARNINGS SECTION

Keep away from eyes. Do not take by mouth.

Earache drops are only to be used in ears.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - DO NOT USE SECTION

Do not use if you have ear tubes, damaged ear drums or after ear surgery.

OTC - ASK DOCTOR/PHARMACIST 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).

Drug Facts (continued)

SPL UNCLASSIFIED SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all medications out of the reach of children. If swallowed, 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

■ Shake well before using.

Children ages 2 years and over: Tilt head sideways and apply 3-4 drops into involved ear (Tip of applicator should not enter ear canal). Keep head tilted for at least 2 minutes to keep drops in ear. Repeat until relieved, up to 4 times daily.

Other information

OTHER SAFETY INFORMATION

■ Do not use if imprinted "SEALED FOR YOUR PROTECTION" tamper-evident bottle cap band is broken or missing.

■ Store at room temperature.

■ Do not refrigerate.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Citric Acid, Glycerine, Purified Water, Sodium Benzoate.

Questions or comments?

OTC - QUESTIONS SECTION

(800) 624-9659

Indications and Usage (Uses)

RECENT MAJOR CHANGES SECTION

Temporarily relieves symptoms of earache in children, including: ■ minor fever ■ ear pain or throbbing ■ common pain or

itching of "swimmer’s ear" ■ irritability or occasional sleeplessness associated with earaches after diagnosis by a physician

Dosage and Administration (Directions)

RECENT MAJOR CHANGES SECTION

■ Shake well before using.

Children ages 2 years and over: Tilt head sideways and apply 3-4 drops into involved ear (Tip of applicator should not enter ear canal). Keep head tilted for at least 2 minutes to keep drops in ear. Repeat until relieved, up to 4 times daily.

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HOMEOPATHIC

NDC 54973-3392-1

2-12

YEARS

NEW

LOOK

4 KIDS

SINCE 1903

Hyland's

Earache

Relief*

Relieves earache

due to swimmer’s ear,

cold, flu & allergy

NO DYES or PARABENS

NO NUMBING EFFECT

NATURAL

RELIEF*

0.33 FL. OZ. (10 mL)

*SEE NOTE ON SIDE

PANEL BELOW DRUG FACTS

CartonCarton

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54973-33924 KIDS EARACHE RELIEF (ATROPA BELLADONNA,OYSTER SHELL CALCIUM CARBONATE, CRUDE,LYCOPODIUM CLAVATUM SPORE,ANEMONE PULSATILLA,SULFUR AND MATRICARIA CHAMOMILLA) LIQUID [HYLAND’S]5Legacy NDC20221124_7ee2a9f8-4a16-4a9d-e053-2a91aa0a1be7.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54973-339254973-3392-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
413a2b13-cb5e-c77c-e063-6294a90a60387ee2a9f8-4a16-4a9d-e053-2a91aa0a1be72025-10-15WarningsExact identifier
spl set id: 7ee2a9f8-4a16-4a9d-e053-2a91aa0a1be7

Reported adverse events (FAERS/openFDA)#

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