Label: DIPHENHYDRAMINE HYDROCHLORIDE injection

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

Drug Label Information

Updated August 26, 2024

If you are a consumer or patient please visit this version.

  • DESCRIPTION
    Diphenhydramine Hydrochloride Injection is a sterile, nonpyrogenic solution for intravenous or deep intramuscular use as an antihistaminic agent. Each mL contains diphenhydramine hydrochloride 50 ...
  • 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 ...
  • INDICATIONS AND USAGE
    Diphenhydramine Hydrochloride Injection is effective in adults and pediatric patients, other than premature infants and neonates, for the following conditions when the oral form is ...
  • 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 ...
  • WARNINGS
    Antihistamines should be used with considerable caution in patients with narrow-angle glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction, symptomatic prostatic hypertrophy or ...
  • 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 ...
  • ADVERSE REACTIONS
    The most frequent adverse reactions are italicized. GENERAL - Urticaria; drug rash; anaphylactic shock; photosensitivity; excessive perspiration; chills; dryness of mouth, nose and ...
  • 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 ...
  • DOSAGE AND ADMINISTRATION
    THIS PRODUCT IS FOR INTRAVENOUS OR INTRAMUSCULAR ADMINISTRATION ONLY. Diphenhydramine Hydrochloride Injection is indicated when the oral form is impractical. DOSAGE SHOULD BE INDIVIDUALIZED ...
  • HOW SUPPLIED
    Diphenhydramine Hydrochloride Injection, USP 50 mg/mL - 1 mL vials packaged in 25s (NDC 0641-0376-25)  Product repackaged by: Henry Schein, Inc., Bastian, VA 24314 - From Original ...
  • Sample Package Label
    Label1.jpg
  • INGREDIENTS AND APPEARANCE
    Product Information