Label: DIPHENHYDRAMINE HCL ORAL SOLUTION- diphenhydramine hcl oral solution

  • NDC Code(s): 57237-317-05, 57237-317-51
  • Packager: Rising Pharma Holdings, Inc.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated January 23, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient per 5 mL (1 Unit Dose)

    Diphenhydramine HCl 12.5 mg

  • Purpose

    Antihistamine

  • Uses

    • Temporarily relieves these symptoms due to hay fever or other respiratory allergies:

       • runny nose   • sneezing   • itchy, watery eyes   • itching of the nose or throat

  • Warnings

    Do not use

    • to make a child sleepy
    • with any other product containing diphenhydramine, even one used on skin

    Ask a doctor before use if the child has

    • 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

    • marked drowsiness may occur
    • sedatives and tranquilizers may increase drowsiness
    • excitability may occur, especially in children

    Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)

  • Directions

    • take every 4 to 6 hours, or as directed by a physician
    • do not take more than 6 doses in 24 hours

    agedose
    Children under 2 years of ageDo not use
    Children 2 to under 6 years of ageDo not use unless directed by a doctor
    Children 6 to under 12 years of age5 mL (12.5 mg) to 10 mL (25 mg)

  • Other information

    • each 5 mL contains sodium: 3 mg
    • store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]
    • do not use if lid is torn or broken

  • Inactive ingredients: citric acid, flavor, FD&C red#40, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, and sucralose

  • Questions or comments? Call 1-844-474-7464

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    Rising Pharma Holdings, Inc.
    East Brunswick, NJ 08816

    FG-35/Iss.: 10/2023

  • NDC Information -

    12.5 mg/5 mL

    Each 5 mL of Diphenhydramine HCl Oral Solution contains Diphenhydramine HCl 12.5 mg and is supplied in the following oral dosage forms:

    NDC 57237-317-05: 5 mL unit dose cup

    NDC 57237-317-51: 100 x 5 mL Unit-Dose Cups

  • PRINCIPAL DISPLAY PANEL

    12.5 mg/5 mL

    Case Label NDC 57237-317-51

    Diphenhydramine-Case-lab

    Lid Label NDC 57237-317-05
    Diphenhydramine-Lid-lab
  • INGREDIENTS AND APPEARANCE
    DIPHENHYDRAMINE HCL ORAL SOLUTION 
    diphenhydramine hcl oral solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57237-317
    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
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorredScore    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57237-317-51100 in 1 BOX, UNIT-DOSE12/15/2023
    1NDC:57237-317-055 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM12/15/2023
    Labeler - Rising Pharma Holdings, Inc. (116880195)
    Registrant - Lohxa (079872715)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lohxa079872715pack(57237-317)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ultrum Labs, LLC060934179manufacture(57237-317) , analysis(57237-317)
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