DoloEar description, usages, side effects, indications, overdosage, supplying and lots more!

DoloEar

Pharmadel LLC

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
DoloEar™

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Purpose

Active Ingredients HPUS: Purpose
Belladonna 6C Pain in ears, inflammation
Apis mellifica 6C Pain in ears, inflammation
Aristolochia clematis 6C Ear pain with tinnitus
Chamomilla 6C Earache, toothache
Lachesis mutus 6C Ear pain with wax build up
Thuja occidentalis 6C Otalgia with noises in ears

Uses

For the temporary relief of earache associated with cold and flu, sore throat, swimmer's ear, sinusitis or wax build up.

Warnings

For use in ears only.

Do not use if you have: ear drainage, discharge, dizziness, ear tubes, damaged ear drum, or fever of 102 or greater.

Consult a physician before use: if pregnant or breastfeeding, in children under 2 years of age.

Stop use and ask your doctor: if symptoms worsen, reoccur, or persist for more than 48 hours, or if fever develops.

Keep out of the reach of children

Do not use if neckband is missing or broken

Directions

Adults and children: Remove tamper-evident neckband from bottle. Shake bottle before each use. Tilt head sideways and apply 2-3 drops into ear (to preserve purity, prevent tip of dropper from touching ear.) Allow drops to remain in ear by keeping head tilted or placing cotton in ear. Repeat as needed.

Inactive Ingredients

Glycerin USP, DI water.

Questions, Comments?

call 1-866-359-3478 M-F 9 AM to 5 PM Eastern Time

Distributed by:
PHARMADEL LLC.®
Seaford, DE 19973

PRINCIPAL DISPLAY PANEL - 15mL Bottle Label

DoloEar

Homeopathic Ear Drops

For the temporary relief of:
earache associated
with cold and flu,
sore throat,
swimmer's ear,
sinusitis or
wax build up.

0.50 FL OZ (15mL)

PRINCIPAL DISPLAY PANEL - 15mL Bottle Label

DoloEar

Atropa Belladonna, Apis Mellifera, Aristolochia Clematitis Root, Matricaria Recutita, Lachesis Muta Venom, and Thuja Occidentalis Leafy Twig SOLUTION/ DROPS

Product Information

Product Type Human otc drug label Item Code (Source) NDC:55758-001
Route of Administration AURICULAR (OTIC) DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ATROPA BELLADONNA ATROPA BELLADONNA 6 [hp_C]
APIS MELLIFERA APIS MELLIFERA 6 [hp_C]
Aristolochia Clematitis Root ARISTOLOCHIA CLEMATITIS ROOT 6 [hp_C]
Matricaria Recutita MATRICARIA RECUTITA 6 [hp_C]
LACHESIS MUTA VENOM LACHESIS MUTA VENOM 6 [hp_C]
THUJA OCCIDENTALIS LEAFY TWIG THUJA OCCIDENTALIS LEAFY TWIG 6 [hp_C]

Inactive Ingredients

Ingredient Name Strength
GLYCERIN
water

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:55758-001-15 15 in 1 BOTTLE, DROPPER

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2013-05-23


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