Label: DIPHENHYDRAMINE HYDROCHLORIDE - diphenhydramine hydrochloride capsule 

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated 03/13

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  • SPL UNCLASSIFIED

    Revised MAY 1999

    1000590101

    Rx only

     

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  • 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:

    MM1

    C17H21NO • HCl Molecular Weight: 291.82

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

     

    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.

     

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  • 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.

     

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  • INDICATIONS & USAGE

    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.

     

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  • CONTRAINDICATIONS

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

     

    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.

     

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  • 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.

     

    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.

     

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

     

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  • PRECAUTIONS

    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.

     

    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.

     

    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.

     

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

     

    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.

     

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  • 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.

     

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  • 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.

     

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  • DOSAGE & 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.

     

    25 to 50 mg three or four times daily. The nighttime sleep-aid dosage is 50 mg at bedtime.

     

    (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.

     

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  • 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 stylized barr 059.
    Available in bottles of:
    100 NDC 0555-0059-02
    1000 NDC 0555-0059-05

    Dispense with a child-resistant closure in a tight container as defined in the USP/NF.

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

     

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  • SPL UNCLASSIFIED

    MANUFACTURED BY
    BARR LABORATORIES, INC.
    POMONA, NY 10970

    Revised MAY 1999
    BR-059

     

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  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

    DRUG: Diphenhydramine Hydrochloride
    GENERIC: Diphenhydramine Hydrochloride
    DOSAGE: CAPSULE
    ADMINSTRATION: ORAL
    NDC: 52125-175-02
    STRENGTH:50 mg
    COLOR: pink
    SHAPE: CAPSULE
    SCORE: No score
    SIZE: 14 mm
    IMPRINT: 30
    QTY: 30

    MM2MM3

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  • INGREDIENTS AND APPEARANCE
    DIPHENHYDRAMINE HYDROCHLORIDE 
    diphenhydramine hydrochloride capsule
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:52125-175(NDC:0555-0059)
    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 Score no score
    Shape CAPSULE (CAPSULE) Size 14mm
    Flavor Imprint Code barr;059
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:52125-175-02 30 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA080738 03/25/2013
    Labeler - REMEDYREPACK INC. (829572556)
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