Label: ALLERGY RELIEF- diphenhydramine hcl liquid

  • NDC Code(s): 54859-837-04
  • Packager: LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 27, 2024

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  • ACTIVE INGREDIENT

    Active ingredient (in each 5 mL teaspoonful)

    Diphenhydramine HCl 12.5 mg

  • PURPOSE

    Purpose

    Antihistamine

  • INDICATIONS & USAGE

    Uses

    • Temporarily relieves these symptoms of hay fever or other upper respiratory allergies:
    • runny nose
    • sneezing
    • itching of the nose or throat
    • itchy, watery eyes
  • WARNINGS

    Warnings

    Do not use

    • with any other product conatining diphenhydramine, including one used on the skin
    • to make a child sleepy

    Ask a doctor before use if you have

    • a breathing problem such as chronic bronchitis
    • glaucoma

    Ask a doctor or pharmacist before use if the child is

    taking sedatives or tranquilizers.

    When using this product

    • do not exceed recommended dose
    • excitability may occur, especially in children
    • marked drowsiness may occur
    • sedatives, and tranquilizers may increase drowsiness
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    • take every 4 to 6 hours as needed, or as directed by a doctor
    • do not take more than 6 doses in 24 hours
    • use dosing cup provided.

    AgeDosage
    Children 6 to 11 years5 mL to 10 mL
    Children2 to 5 yearsDo not use unless directed by a doctor
    Children under 2 yearsDo not use

  • INACTIVE INGREDIENT

    Inactive ingredients: Artificial and natural cherry flavor, citric acid, FD&C #40, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, sucralose and sucrose.

  • QUESTIONS

    Questions or comments? 1-866-595-5598

  • PRINCIPAL DISPLAY PANEL

    allergy

  • INGREDIENTS AND APPEARANCE
    ALLERGY RELIEF 
    diphenhydramine hcl liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54859-837
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SUCROSE (UNII: C151H8M554)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54859-837-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product12/01/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01212/01/2024
    Labeler - LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION (037342305)
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