Diphenhydramine Hydrochloride: Package Insert and Label Information

DIPHENHYDRAMINE HYDROCHLORIDE- diphenhydramine hydrochloride capsule
UDL Laboratories, Inc.

Rx only

DESCRIPTION:

Diphenhydramine Hydrochloride is an antihistamine drug having the chemical name 2-(diphenylmethoxy)-N , N -dimethylethylamine hydrochloride. It occurs as a white, odorless crystalline powder and is freely soluble in water and alcohol. The structural formula is as follows:

structural formula
(click image for full-size original)

C17 H21 NO • HCl Molecular Weight: 291.82

Each capsule contains 50 mg of diphenhydramine hydrochloride for oral administration.

Inactive Ingredients:

Anhydrous lactose, lactose monohydrate and magnesium stearate.

The 50 mg capsule shell contains D&C red no. 28, FD&C blue no. 1, FD&C red no. 40, gelatin, silicon dioxide and sodium lauryl sulfate.

The imprinting ink contains D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, FD&C blue no. 2 aluminum lake, FD&C red no. 40 aluminum lake, pharmaceutical glaze, propylene glycol and synthetic black iron oxide.

CLINICAL PHARMACOLOGY:

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.

INDICATIONS AND USAGE:

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

Antihistaminic:

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.

Motion Sickness:

For active and prophylactic treatment of motion sickness.

Antiparkinsonism:

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.

CONTRAINDICATIONS:

Use in Newborn or Premature Infants:

This drug should not be used in newborn or premature infants.

Use in Nursing Mothers:

Because of the higher risk of antihistamines for infants generally, and for newborns and prematures in particular, antihistamine therapy is contraindicated in nursing mothers.

Antihistamines are also contraindicated in the following conditions: Hypersensitivity to diphenhydramine hydrochloride and other antihistamines of similar chemical structure.

WARNINGS:

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.

Use in Children:

In infants and children, especially, antihistamines in overdosage may cause hallucinations, convulsions, or death.

As in adults, antihistamines may diminish mental alertness in children. In the young child, particularly, they may produce excitation.

Use in Elderly (approximately 60 years or older):

Antihistamines are more likely to cause dizziness, sedation, and hypotension in elderly patients.

PRECAUTIONS:

General:

Diphenhydramine hydrochloride has an atropine-like action and therefore should be used with caution in patients with a history of lower respiratory disease including asthma, increased intraocular pressure, hyperthyroidism, cardiovascular disease or hypertension.

Information for Patients:

Patients taking diphenhydramine hydrochloride should be advised that this drug may cause drowsiness and has an additive effect with alcohol.

Patients should be warned about engaging in activities requiring mental alertness such as driving a car or operating appliances, machinery, etc.

Drug Interactions:

Diphenhydramine hydrochloride has additive effects with alcohol and other CNS depressants (hypnotics, sedatives, tranquilizers, etc).

MAO inhibitors prolong and intensify the anticholinergic (drying) effects of antihistamines.

Carcinogenesis, Mutagenesis, Impairment of Fertility:

Long-term studies in animals to determine mutagenic and carcinogenic potential have not been performed.

Pregnancy:

Pregnancy Category B:

Reproduction studies have been performed in rats and rabbits at doses up to 5 times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due to diphenhydramine hydrochloride. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

ADVERSE REACTIONS:

The most frequent adverse reactions are underscored.

  1. General: Urticaria, drug rash, anaphylactic shock, photosensitivity, excessive perspiration, chills, dryness of 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 and wheezing, nasal stuffiness.

OVERDOSAGE:

Antihistamine overdosage reactions may vary from central nervous system depression to stimulation. Stimulation is particularly likely in children. 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. Precautions 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 (½) 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 AND ADMINISTRATION:

DOSAGE SHOULD BE INDIVIDUALIZED ACCORDING TO THE NEEDS AND 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.

CHILDREN:

(over 20 lb): 12.5 to 25 mg three to 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.

HOW SUPPLIED:

Diphenhydramine Hydrochloride Capsules, USP are available as:

50 mg: Pink clear cap/pink clear body filled with white powder.
Imprinted in black ink barr 059.

NDC 51079-066-19 — Robot Ready blister packages of 25 (25 cards of 1 capsule each).
NDC 51079-066-20 — Unit dose blister packages of 100 (10 cards of 10 capsules each).

Store at controlled room temperature 15°-30°C (59°-86°F).

Manufactured by:
Barr Laboratories, Inc.
Pomona, NY 10970

Packaged and Distributed by:
UDL Laboratories, Inc.
Rockford, IL 61103

S-3458 R11
6/07

PRINCIPAL DISPLAY PANEL — 50 mg

NDC 51079-066-20

DIPHENHYDRAMINE
HYDROCHLORIDE
CAPSULES, USP
50 mg

100 Capsules (10 x 10)

USUAL DOSAGE: See
package insert.

Store at controlled room temperature
15°-30°C (59°-86°F).

Manufactured by:
Barr Laboratories, Inc.
Pomona, NY 10970

Rx only

S-3451 R8

Packaged and Distributed by:

UDL LABORATORIES, INC.

ROCKFORD, IL 61103

This unit dose package is not child resistant.

For institutional use only.

Keep this and all drugs out of the reach of children.

This container provides light-resistance.

See window for lot number and expiration date.

Diphenhydramine HCl 50 mg Capsules Unit Carton Label
(click image for full-size original)
Unit Carton
(click image for full-size original)
DIPHENHYDRAMINE HYDROCHLORIDE
diphenhydramine hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51079-066
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE 50 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
D&C RED NO. 28
FD&C BLUE NO. 1
FD&C RED NO. 40
GELATIN
SILICON DIOXIDE
SODIUM LAURYL SULFATE
D&C YELLOW NO. 10
ALUMINUM OXIDE
FD&C BLUE NO. 2
SHELLAC
PROPYLENE GLYCOL
FERROSOFERRIC OXIDE
Product Characteristics
Color PINK (Pink clear) Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code barr;059
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51079-066-20 100 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK (51079-066-01)
1 NDC:51079-066-01 1 CAPSULE in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (51079-066-20)
2 NDC:51079-066-19 25 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK (51079-066-17)
2 NDC:51079-066-17 1 CAPSULE in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (51079-066-19)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA080738 08/23/2011
Labeler — UDL Laboratories, Inc. (039615992)

Revised: 06/2007 UDL Laboratories, Inc.

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