Label: DIPHENHYDRAMINE HYDROCHLORIDE injection, solution

  • NDC Code(s): 67457-124-10
  • Packager: Mylan Institutional LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated June 16, 2021

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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, crystalline powder, is freely soluble in water and alcohol and has a molecular weight of 291.82. The molecular formula is C17H21NO • HCl. The structural formula is as follows:

    Diphenhydramine Structural Formula

    Diphenhydramine hydrochloride in the parenteral form is a sterile, pyrogen-free solution available in a concentration of 50 mg of diphenhydramine hydrochloride per mL. The solutions for parenteral use have been adjusted to a pH between 5.0 and 6.0 with either sodium hydroxide or hydrochloric acid and contains 0.1 mg/mL benzethonium chloride as a germicidal agent.

  • CLINICAL PHARMACOLOGY

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

    Diphenhydramine hydrochloride in the injectable form has a rapid onset of action. Diphenhydramine hydrochloride is widely distributed throughout the body, including the CNS. A portion of the drug is excreted unchanged in the urine, while the rest is metabolized via the liver. Detailed information on the pharmacokinetics of Diphenhydramine Hydrochloride Injection is not available.

  • INDICATIONS AND USAGE

    Diphenhydramine hydrochloride injection, is effective in adults and pediatric patients, other than premature infants and neonates, for the following conditions when diphenhydramine hydrochloride in the oral form is impractical.

    Antihistaminic

    For amelioration of allergic reactions to blood or plasma, in anaphylaxis as an adjunct to epinephrine and other standard measures after the acute symptoms have been controlled, and for other uncomplicated allergic conditions of the immediate type when oral therapy is impossible or contraindicated.

    Motion sickness

    For active treatment of motion sickness.

    Antiparkinsonism

    For use in parkinsonism, when oral therapy is impossible or contraindicated, as follows: parkinsonism in the elderly who are unable to tolerate more potent agents; mild cases of parkinsonism in other age groups, and in other cases of parkinsonism in combinations with centrally acting anticholinergic agents.

  • CONTRAINDICATIONS

    Use in Neonates or Premature Infants

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

    Use in Nursing Mothers

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

    Use as a Local Anesthetic

    Because of the risk of local necrosis, this drug should not be used as a local anesthetic.

    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.

    Local necrosis has been associated with the use of subcutaneous or intradermal use of intravenous diphenhydramine hydrochloride.

    Use in Pediatric Patients

    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.

    Use in the 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 bronchial asthma, increased intraocular pressure, hyperthyroidism, cardiovascular disease or hypertension. Use with caution in patients with lower respiratory disease including asthma.

    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

    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.

    Pediatric Use

    Diphenhydramine hydrochloride should not be used in neonates and premature infants (see CONTRAINDICATIONS).

    Diphenhydramine hydrochloride may diminish mental alertness, or, in the young pediatric patient, cause excitation. Overdosage may cause hallucinations, convulsions, or death (see WARNINGS and OVERDOSAGE).
    See also DOSAGE AND ADMINISTRATION section

  • 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 or throat and wheezing, nasal stuffiness
  • OVERDOSAGE

    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.

    Stimulants should not be used.

    Vasopressors may be used to treat hypotension.

  • DOSAGE AND ADMINISTRATION

    THIS PRODUCT IS FOR INTRAVENOUS OR INTRAMUSCULAR ADMINISTRATION ONLY.

    Diphenhydramine hydrochloride injection, is indicated when the oral form is impractical.

    Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

    DOSAGE SHOULD BE INDIVIDUALIZED ACCORDING TO THE NEEDS AND THE RESPONSE OF THE PATIENT.

    Pediatric Patients, other than premature infants and neonates

    5 mg/kg/24 hr or 150 mg/m2/24 hr. Maximum daily dosage is 300 mg. Divide into four doses, administered intravenously at a rate generally not exceeding 25 mg/min, or deep intramuscularly.

    Adults

    10 mg to 50 mg intravenously at a rate generally not exceeding 25 mg/min, or deep intramuscularly, 100 mg if required; maximum daily dosage is 400 mg.

  • HOW SUPPLIED

    Diphenhydramine Hydrochloride Injection, USP is supplied as a sterile solution containing 50 mg diphenhydramine hydrochloride in each milliliter of solution with 0.1 mg/mL benzethonium chloride as a germicidal agent. Available in multi-dose 10 mL (NDC 67457-124-10) vials.

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

    Manufactured for:
    Mylan Institutional LLC
    Morgantown, WV 26505 U.S.A.

    Manufactured by:
    Mylan Institutional
    Galway, Ireland

    1012L101
    MI:DIHYIJ:R4
    Revised: 6/2021

  • PRINCIPAL DISPLAY PANEL - 50 mg/mL 

    NDC 67457-124-10     10 mL

    diphenhydrAMINE
    Hydrochloride
    Injection, USP
    500 mg/10 mL
    (50 mg/mL)

    For Intravenous or
    Intramuscular Use

    HIGH POTENCY
    Rx only     Multi-Dose Vial

    Usual Adult Dosage:
    0.2 mL to 1 mL
    intravenously or
    intramuscularly, or more
    as required. See
    accompanying
    prescribing information.

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

    Protect from freezing
    and light.

    MI:124:1C:R6

    Sterile. Pyrogen-Free.

    Each mL contains:
    Diphenhydramine
    Hydrochloride 50 mg,
    Benzethonium Chloride
    0.1 mg, as a germicidal
    agent in Water for
    Injection. The pH may
    have been adjusted
    with Sodium Hydroxide
    and/or Hydrochloric
    Acid.

    Manufactured for:
    Mylan Institutional LLC
    Morgantown, WV 26505 U.S.A.

    Manufactured by:
    Mylan Institutional
    Galway, Ireland

    Mylan.com

    Diphenhydramine Hydrochloride Injection USP, 500 mg/10 mL Carton Label
  • INGREDIENTS AND APPEARANCE
    DIPHENHYDRAMINE HYDROCHLORIDE 
    diphenhydramine hydrochloride injection, solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:67457-124
    Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE50 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZETHONIUM CHLORIDE (UNII: PH41D05744) 0.1 mg  in 1 mL
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67457-124-101 in 1 CARTON05/09/2013
    110 mL in 1 VIAL, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA04049805/09/2013
    Labeler - Mylan Institutional LLC (790384502)
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