FDA records indicate that there are no current recalls for this drug.
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Baby Infant Earache Drops Recall
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Questions & Answers
Side Effects & Adverse Reactions
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.
As with any drug, ask a doctor betore use if pregnant or nursing.
Consult a physician if symptoms persist for more than 48 hours or if there is discharge from the ear.
Keep this and all medicafions out of the reach of children. In case of accidental overdose, contact a medical professional or poison control center immediately.
Do not use if tamper band is broken or missing.
Consult a physician if symptoms persist for more than 48 hours or if there is discharge from the ear.
Do not use if tamper band is broken or missing.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Temporarily relieves the symptoms of fever, pain, irritability, and sleeplessness associated with earaches in children, after diagnosis by a physician. Relieves common pain and itching of swimmer's ear. If symptoms persist for more than 48 hours, or if there is a discharge from the ear, discontinue use and contact your physician.
History
There is currently no drug history available for this drug.
Other Information
There are no additional details available for this product.
Sources
Baby Infant Earache Drops Manufacturers
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Hyland’s
Baby Infant Earache Drops | Pd-rx Pharmaceuticals, Inc.
The dosage of Penicillin V should be determined according to the sensitivity of the causative microorganism and the severity of infection, and adjusted to the clinical response of the patient.
The usual dosage recommendations for adults and children 12 years and over are as follows:
Streptococcal Infection
Mild to moderately severe - of the upper respiratory tract and including scarlet fever and erysipelas: 125 to 250 mg (200,000 to 400,000 units) every 6 to 8 hours for 10 days.
Pneumococcal Infections
Mild to moderately severe - of the respiratory tract, including otitis media: 250 to 500 mg (400,000 to 800,000 units) every 6 hours until the patient has been afebrile for at least 2 days.
Staphylococcal Infections
Mild infections of skin and soft tissue (culture and sensitive tests should be performed): 250 to 500 mg (400,000 to 800,000 units) every 6 to 8 hours.
Fusospirochetosis (Vincent’s infection) of the oropharynx. Mild to moderately severe infections: 250 to 500 mg (400,000 to 800,000 units) every 6 to 8 hours.
For the prevention of recurrence following rheumatic fever and/or chorea: 125 mg to 250 mg (200,000 to 400,000 units) twice daily on a continuing basis.
For prophylaxis against bacterial endocarditis1 in patients with congenital heart disease or rheumatic or other acquired valvular heart disease when undergoing dental procedures or surgical procedures of the upper respiratory tract: 2 gram of penicillin V (1 gram for children under 60 lbs.) 1 hour before the procedure, and then, 1 gram (500 mg for children under 60 lbs.) 6 hours later.
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