Premier Value Ear Relief Ear Drops

Manufacturer: Chain Drug Consortium, LLC | Bell Pharmaceuticals, Inc.
Effective date: 2021-02-23
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-06-01 02:14:24

Label at a glance#

ProductPremier Value Ear Relief Ear Drops

Active ingredientCHAMOMILE, MERCURIUS SOLUBILIS, SULFUR

Label structure8 sections

Indications and uses

Helps relieve the sensation of fullness 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 direted by a doctor. Children under 12 years of age consult a doctor.

Contacts and useful links#

PhoneLabel contact1-800-328-5890

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Chamomilla 10X

Mercurius solubilis 15X

Sulphur 12X

Purpose

OTC - PURPOSE SECTION

sensitivity to dreafts, soothing

fullness, sensitivity to cold

itchiness, sensitivity to water

Uses

INDICATIONS & USAGE SECTION

Helps relieve the sensation of fullness 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

Do not use

OTC - DO NOT USE SECTION

in the eyes.
Initial 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 direted 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 ingredient

INACTIVE INGREDIENT SECTION

Vegetable glycerin

Questions?

OTC - QUESTIONS SECTION

1-800-328-5890

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68016-377-00	Premier Value Ear Relief Ear Drops	1 in 1 BOX	SOLUTION/ DROPS	1		2
68016-377-00	Premier Value Ear Relief Ear Drops	12 mL in 1 BOTTLE	SOLUTION/ DROPS	12		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68016-377	PREMIER VALUE EAR RELIEF EAR DROPS (CHAMOMILE, MERCURIUS SOLUBILIS, SULFUR) SOLUTION/ DROPS [CHAIN DRUG CONSORTIUM, LLC]	2	Current NDC, Legacy NDC, 2 package rows	20210224_b0db3da2-c180-4ff5-a8ee-4ec220798f64.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68016-377-00	ML - Milliliter	68016-377	dc66c236-ff10-47dd-a3c7-b0e45ff08e4c	1	2022-06-06

Products#

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

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

Premier Value Ear Relief Ear Drops
CHAMOMILE, MERCURIUS SOLUBILIS, SULFUR
GLYCERIN
CHAMOMILE
MERCURIUS SOLUBILIS
SULFUR

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
68016-377	68016-377-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
GLYCERIN	PDC6A3C0OX	IACT
CHAMOMILE	FGL3685T2X	ACTIB
MERCURIUS SOLUBILIS	324Y4038G2	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
Premier Value Ear Relief Ear Drops	CHAMOMILE, MERCURIUS SOLUBILIS, SULFUR	Chain Drug Consortium, LLC	b0db3da2-c180-4ff5-a8ee-4ec220798f64	2021-02-23	Warnings	Exact identifier ndc (package): 68016-377-00 ndc (product): 68016-377 ndc11 (package): 68016037700 spl id: bbfef157-79e8-7305-e053-2995a90aa962 spl set id: b0db3da2-c180-4ff5-a8ee-4ec220798f64

Reported adverse events (FAERS/openFDA)#

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