FDA records indicate that there are no current recalls for this drug.
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Questions & Answers
Side Effects & Adverse Reactions
Antihistamines should be used with considerable caution in patients with narrow-angle glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction, symptomatic prostatic hypertrophy, or bladder-neck obstruction.
In pediatric patients, especially, antihistamines in overdosage may cause hallucinations, convulsions, or death. As in adults, antihistamines may diminish mental alertness in pediatric patients. In the young pediatric patient, particularly, they may produce excitation.
Antihistamines are most likely to cause dizziness, sedation, and hypotension in elderly patients.
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
Diphenhydramine hydrochloride in the oral form is effective for the following indications:
For allergic conjunctivitis due to foods; mild, uncomplicated allergic skin manifestations of urticaria and angioedema; amelioration of allergic reactions to blood or plasma; dermatographism; as therapy for anaphylactic reactions adjunctive to epinephrine and other standard measures after the acute manifestations have been controlled.
For active and prophylactic treatment of motion sickness.
For parkinsonism (including drug-induced) in the elderly unable to tolerate more potent agents; mild cases of parkinsonism (including drug-induced) in other age groups; in other cases of parkinsonism (including drug-induced) in combination with centrally acting anticholinergic agents.
Nighttime Sleep-aid.
History
There is currently no drug history available for this drug.
Other Information
Diphenhydramine hydrochloride is an antihistamine drug having the chemical name 2- (diphenylmethoxy)-N,N -dimethylethylamine hydrochloride and has the molecular formula C17H21NO•HCL (molecular weight 291.82). It occurs as a white odorless, crystalline powder and is freely soluble in water and alcohol. The structural formula is as follows:
Each 5 mL contains 12.5 mg of diphenhydramine hydrochloride and alcohol 14% for oral administration.
INACTIVE INGREDIENTS:
Citric acid, D&C Red No.33, FD&C Red No.40, flavoring, purified water, sodium citrate, and sucrose.
Sources
New Skin Bandage Manufacturers
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Medtech Products Inc.
New Skin Bandage | Cardinal Health
DOSAGE SHOULD BE INDIVIDUALIZED ACCORDING TO THE NEEDS AND THE RESPONSE OF THE PATIENT.
A single oral dose of diphenhydramine hydrochloride is quickly absorbed with maximum activity occurring in approximately one hour. The duration of activity following an average dose of diphenhydramine hydrochloride is from four to six hours.
Adults
25 to 50 mg three or four times daily. The nighttime sleep-aid dosage is 50 mg at bedtime.
Pediatric Patients, other than premature infants and neonates
12.5 to 25 mg three or four times daily. Maximum daily dosage not to exceed 300 mg. For physicians who wish to calculate the dose on the basis of body weight or surface area, the recommended dosage is 5 mg/kg/24 hours or 150 mg/m2/24 hours.
Data are not available on the use of diphenhydramine hydrochloride as a nighttime sleep-aid in children under 12 years.
The basis for determining the most effective dosage regimen will be the response of the patient to medication and the condition under treatment.
In motion sickness, full dosage is recommended for prophylactic use, the first dose to be given 30 minutes before exposure to motion and similar doses before meals and upon retiring for the duration of exposure.
STORAGE:Keep tightly closed. Store at 20° to 25°C (67° to 77°F). [See USP Controlled Room Temperature]. Protect from freezing and light.
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