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  5. Label Information: Premier Value Ear Relief Ear Drops

FDA Label for Premier Value Ear Relief Ear Drops

View Indications, Usage & Precautions

Table of Contents

    1. DRUG FACTS
    2. ACTIVE INGREDIENTS
    3. PURPOSE
    4. USES
    5. WARNINGS
    6. DO NOT USE
    7. ASK A DOCTOR BEFORE USE IF YOU HAVE:
    8. STOP USE AND ASK A DOCTOR IF:
    9. IF PREGNANT OR BREAST FEEDING,
    10. KEEP OUT OF REACH OF CHILDREN.
    11. DIRECTIONS
    12. OTHER INFORMATION
    13. INACTIVE INGREDIENT
    14. QUESTIONS?
    15. PACKAGE LABELING:

Premier Value Ear Relief Ear Drops Product Label

The following document was submitted to the FDA by the labeler of this product Chain Drug Consortium, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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:



Bottle3 - Bottle3

Bottle3 - Bottle3


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