Diphenhydramine Hydrochloride Oral Solution USP

Rx ONLY

Diphenhydramine hydrochloride is an antihistamine drug having the chemical name 2-(diphenylmethoxy)-N,N -dimethylethylamine hydrochloride and has the molecular formula C₁₇H₂₁NO∙HCI (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.

Diphenhydramine hydrochloride is an antihistamine with anticholinergic (drying) and sedative effects. Antihistamines appear to compete with histamine for cell receptor sites on effector cells.

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. Diphenhydramine is widely distributed throughout the body, including the CNS. Little, if any, is excreted unchanged in the urine; most appears as the degradation products of metabolic transformation in the liver, which are almost completely excreted within 24 hours.

Diphenhydramine hydrochloride in the oral form is effective for the following indications:

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.

The most frequent adverse reactions are underscored.

1. General: Urticaria, drug rash, anaphylactic shock, photosensitivity, excessive perspiration, chills, dryness of the mouth, nose and throat.
2. Cardiovascular System: Hypotension, headache, palpitations, tachycardia, extrasystoles.
3. Hematologic System: Hemolytic anemia, thrombocytopenia, agranulocytosis.
4. Nervous System: Sedation, sleepiness, dizziness, disturbed coordination, fatigue, confusion, restlessness, excitation, nervousness, tremor, irritability, insomnia, euphoria, paresthesia, blurred vision, diplopia, vertigo, tinnitus, acute labyrinthitis, neuritis, convulsions.
5. GI System: Epigastric distress, anorexia, nausea, vomiting, diarrhea, constipation.
6. GU System: Urinary frequency, difficult urination, urinary retention, early menses.
7. Respiratory System: Thickening of bronchial secretions, tightness of chest or throat and wheezing, nasal stuffiness.

To report SUSPECTED ADVERSE REACTIONS, contact Redmont Pharmaceuticals, Inc. at 1-800-986-5909 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Antihistamine overdosage reactions may vary from central nervous system depression to stimulation. Stimulation is particularly likely in pediatric patients. Atropine-like signs and symptoms, dry mouth; fixed, dilated pupils; flushing and gastrointestinal symptoms may also occur.

If vomiting has not occurred spontaneously, the patient should be induced to vomit. This is best done by having him drink a glass of water or milk after which he should be made to gag. Precaution against aspiration must be taken, especially in infants and children.

If vomiting is unsuccessful, gastric lavage is indicated within 3 hours after ingestion and even later if large amounts of milk or cream were given beforehand. Isotonic or 1/2 isotonic saline is the lavage solution of choice.

Saline cathartics, as milk of magnesia, by osmosis draw water into the bowel and therefore are valuable for their action in rapid dilution of bowel content.

Stimulants should not be used.

Vasopressors may be used to treat hypotension.

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.

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Protect from freezing and light.

Each 5 mL of Diphenhydramine Hydrochloride Oral Solution USP (clear purple/red liquid, cinnamon/anise flavor) contains 12.5 mg diphenhydramine hydrochloride with 14% alcohol and is supplied in the following oral dosage forms:

NDC 71741-511-04: 118mL Bottle

Distributed by:

Redmont
Pharmaceuticals, LLC
Birmingham, AL 35209

X048904R0626 R06/26

NDC 71741-511-04

Diphenhydramine
HCL

Oral Solution, USP

12.5 mg/5 mL

Each 5 mL (teaspoonful) contains:
Diphenhydramine HCl.....12.5 mg
Alcohol.......................14%

Rx Only ∙ 118 mL

REDMONT
PHARMACEUTICALS