Family Wellness Ear Relief Ear Drops

Manufacturer
Family Dollar Services Inc | Bell Pharmaceuticals, Inc.
Effective date
2024-12-09
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:29:26

Label at a glance#

ProductFamily Wellness Ear Relief Ear Drops
Active ingredientMATRICARIA CHAMOMILLA, MERCURIUS SOLUBILIS, SULFUR
Label structure8 sections

Indications and uses

Helps relieve the sensation of fullnes of the ear, sensitivity to water and drafts, and the annoyance of water-clogged ears by helping clear water trapped in the ear.

Dosage and administration

FOR USE IN THE EAR ONLY. Remove tamper-evident seal from neck of bottle. Twist cap off bottle. Tilt head sideways. Apply 4 to 5 drops in each affected ear (applicator should not enter ear canal). Keep drops in ear by keeping head tilted or placing cotton in ear. Use up to 4 times daily for no more than 48 hours, or as directed by a doctor. Children under 12 years of age consult a doctor.

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Chamomilla 10X

Mecurius Soluctions 15X

Sulphur 12X

Purpose

OTC - PURPOSE SECTION

sensitivity to drafts, soothingfullness, sensitivity to cold itchiness, sensitvity to water

Uses

INDICATIONS & USAGE SECTION

Helps relieve the sensation of fullnes of the ear, sensitivity to water and drafts, and the annoyance of water-clogged ears by helping clear water trapped in the ear.

Warnings

WARNINGS SECTION

OTC - DO NOT USE SECTION

  • Do not use in the eyes.
  • Intial exacerbation may occur.

Ask a doctor before use if you have:

OTC - ASK DOCTOR SECTION

  • ear drainage or discharge
  • pain, irritation, or rash in the ear
  • had ear surgery
  • dizziness

Stop use and ask a doctor if:

OTC - STOP USE SECTION

  • irritation (too much burning) or pain occurs
  • symptoms persist for more than 48 hours

If pregnant or breast feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

FOR USE IN THE EAR ONLY.

  • Remove tamper-evident seal from neck of bottle.
  • Twist cap off bottle.
  • Tilt head sideways.
  • Apply 4 to 5 drops in each affected ear (applicator should not enter ear canal).
  • Keep drops in ear by keeping head tilted or placing cotton in ear.
  • Use up to 4 times daily for no more than 48 hours, or as directed by a doctor.
  • Children under 12 years of age consult a doctor.

Other information

SPL UNCLASSIFIED SECTION

Active ingredients are manufactured according to homeopathic principles
Do not use if tamper-evident safety seal is missing or broken

Inactive ingredients

INACTIVE INGREDIENT SECTION

Vegetable glycerin

Questions?

OTC - QUESTIONS SECTION

1-800-328-5890

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55319-804-01Family Wellness Ear Relief Ear Drops12 mL in 1 BOTTLESOLUTION/ DROPS122
55319-804-01Family Wellness Ear Relief Ear Drops1 in 1 CARTONSOLUTION/ DROPS12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55319-804FAMILY WELLNESS EAR RELIEF EAR DROPS (MATRICARIA CHAMOMILLA, MERCURIUS SOLUBILIS, SULFUR) SOLUTION/ DROPS [FAMILY DOLLAR SERVICES INC]2Current NDC, Legacy NDC, 2 package rows20241210_dba89b5c-fe1d-485d-a1af-d8cd1f15b615.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55319-80455319-804-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 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
Family Wellness Ear Relief Ear DropsMATRICARIA CHAMOMILLA, MERCURIUS SOLUBILIS, SULFURFamily Dollar Services Incdba89b5c-fe1d-485d-a1af-d8cd1f15b6152024-12-09WarningsExact identifier
ndc (package): 55319-804-01
ndc (product): 55319-804
ndc11 (package): 55319080401
spl id: 28d9b093-3d3d-4353-e063-6394a90a8d4e
spl set id: dba89b5c-fe1d-485d-a1af-d8cd1f15b615

Reported adverse events (FAERS/openFDA)#

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