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Drug Facts
Earache Drops Liquid
FDA Label NDC 54973-3172
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Hyland's Inc. for the product Earache Drops (NDC 54973-3172). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, otc - active ingredient, uses, warnings, otc - pregnancy or breast feeding, otc - ask doctor, otc - keep out of reach of children, otc - do not use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
| Active ingredients | Purpose |
Belladonna 30C HPUS (0.000000000001% Alkaloids, Calculated | fever |
| Calcarea Carbonica 30C HPUS | throbbing ear pain |
| Chamomilla 30C HPUS | occasional sleeplessness and irritability |
| Lycopodium 30C HPUS | ear pain |
| Pulsatilla 30C HPUS | ear itching, pain worse at night |
| Sulphur 30C HPUS | ear pain with burning |
"HPUS" indicates the active ingredients are in the official Homeopathic Pharmacopœia of the United States.
Uses
Temporarily relieves the symptoms of fever, pain, throbbing, irritability and occasional sleeplessness associated with earaches after diagnosis by a physician. Relieves common pain and itching of "swimmer's" ear.
Warnings
Keep away from eyes. Do not take by mouth. Earache drops are only to be used in the ears. Tip of applicator should not enter ear canal.
Otc - Pregnancy Or Breast Feeding
As with any drug, ask a doctor before use if pregnant or breast-feeding.
Otc - Ask Doctor
Consult a physician if:
- Symptoms persist for more than 48 hours
- Discharge from the ear is present
Otc - Keep Out Of Reach Of Children
Keep this and all medications out of the reach of children. In case of accidental overdose, contact a medical professional or poison control center immediately.
Otc - Do Not Use
Do not use if imprinted tamper band is broken or missing.
Otc - Ask Doctor/Pharmacist
In case of emergency, contact a medical professional or poison control center immediately. Hyland's may also be contacted for emergency information about our products 24 hours a day, 7 days per week at (800) 624-9659.
Directions
Adults and children 2 years and up: Tilt head sideways and apply 3-4 drops into involved ear 4 times daily or as needed. Tilt ear upward for at least 2 minutes after application or gently place cotton in ear to keep drops in.
Inactive Ingredients
Citric Acid, Glycerine, Purified Water, Sodium Benzoate.
Questions Or Comments?
(800) 624-9659
Otc - Purpose
Temporarily relieves the symptoms of fever, pain, throbbing, irritability and occasional sleeplessness associated with earaches after diagnosis by a physician. Relieves common pain and itching of "swimmer's" ear.
Principal Display Panel - 10 Ml Bottle Carton
NDC 54973-3172-1
HOMEOPATHIC
Natural
Relief
SINCE 1903
Hyland's®
EARACHE
DROPS
RELIEVES EAR
PAIN FAST*
CALMS & SOOTHES
EARACHES DUE TO
- COLD & FLU
- SWIMMER'S EAR
- ALLERGY
0.33 FL. OZ.
(10 mL)
* Please review the disclaimer below.
