PREMIER VALUE EAR RELIEF EAR DROPS- chamomile, mercurius solubilis, sulfur solution/ drops

Premier Value Ear Relief Ear Drops by

Drug Labeling and Warnings

Premier Value Ear Relief Ear Drops by is a Homeopathic medication manufactured, distributed, or labeled by Chain Drug Consortium, LLC, Bell Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

Chamomilla 10X

Mercurius solubilis 15X

Sulphur 12X

Purpose

sensitivity to dreafts, soothing

fullness, sensitivity to cold

itchiness, sensitivity to water

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. 

Warnings

Do not use

• in the eyes.
• Initial exacerbation may occur.

Ask a doctor before use if you have:

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

Stop use and ask a doctor if:

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

If pregnant or breast feeding,

ask a health professional before use.

Keep out of reach of children.

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

Directions

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

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

Inactive ingredient

Vegetable glycerin

Questions?

1-800-328-5890

Package Labeling:

INGREDIENTS AND APPEARANCE

PREMIER VALUE EAR RELIEF EAR DROPS 
chamomile, mercurius solubilis, sulfur solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68016-377
Route of Administration	AURICULAR (OTIC)

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHAMOMILE (UNII: FGL3685T2X) (CHAMOMILE - UNII:FGL3685T2X)	CHAMOMILE	10 [hp_X]  in 1 mL
MERCURIUS SOLUBILIS (UNII: 324Y4038G2) (MERCURIUS SOLUBILIS - UNII:324Y4038G2)	MERCURIUS SOLUBILIS	15 [hp_X]  in 1 mL
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	12 [hp_X]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68016-377-00	1 in 1 BOX	10/01/2005
1		12 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		10/01/2005

Labeler - Chain Drug Consortium, LLC (101668460)

Establishment
Name	Address	ID/FEI	Business Operations
Bell Pharmaceuticals, Inc.		140653770	manufacture(68016-377) , label(68016-377)