Label: DIPHENHYDRAMINE HCL ORAL SOLUTION- diphenhydramine hydrochloride solution

  • NDC Code(s): 69339-151-05, 69339-151-17, 69339-151-19, 69339-152-01, view more
    69339-152-17, 69339-152-19
  • Packager: Natco Pharma USA LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 1, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each 5 mL)

    Diphenhydramine HCl USP 12.5 mg

  • Active ingredient (in each 10 mL)

    Diphenhydramine HCl USP 25 mg

  • Purpose

    Antihistamine

  • Uses

    temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: • runny nose • sneezing • itchy, watery eyes • itchy throat

  • Warnings

    Do not use

    • in neonates or premature infants • if pregnant or breast-feeding • if hypersensitive to diphenhydramine HCI and other similar antihistamine • with any other product containing diphenhydramine, even one used on skin • to make a child sleepy

    Ask a doctor before use if you have

    • glaucoma • a breathing problem such as emphysema or chronic bronchitis
    • a sodium restricted diet • trouble urinating due to enlarged prostate gland

    Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives

    When using this product

    • marked drowsiness may occur • avoid alcoholic drinks • alcohol, sedatives, and tranquilizers may increase drowsiness
    • be careful when driving a motor vehicle or operating machinery • excitability may occur, especially in children

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)

  • Directions

    • Use the following dosage guidelines when using this product

    Age (yr)Dose (mL)
    Adults and children 12
    years and older    		take 10 mL every 4 to 6 hours; not more than 60 mL
    in 24 hours.
    Children 6 years to under
    12 years    		take 5 mL every 4 to 6 hours; not more than 30 mL
    in 24 hours
    Children under 6 yearsask a doctor
  • Other information

    • each 5mL contains sodium 10mg
    • each 10mL contains sodium 20mg
    • alcohol free, cherry flavor
    • store at 20-25°C (68-77°F)
    • protect from excessive moisture
    • do not use if lid seal is open or damaged
    • see top of cup for lot number and expiration date

  • Inactive ingredients

    Citric acid, D&C Red No. 33, FD&C Red No. 40, flavor, glycerin, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate,
    and sucrose.

  • How Supplied

    Each 5 mL of Diphenhydramine Hydrochloride Oral Solution, USP contains 12.5mg diphenhydramine hydrochloride and is supplied in the following oral dosage forms:


    NDC 69339-151-05             (1) unit dose cup                         5mL
    NDC 69339-151-17             40 (4x10) unit dose cups            5mL
    NDC 69339-151-19             100 (10x10) unit dose cups        5mL

    Each 10 mL of Diphenhydramine Hydrochloride Oral Solution, USP contains 25mg diphenhydramine hydrochloride and is supplied in the following oral dosage forms:

    NDC 69339-152-01             (1) unit dose cup                         10mL
    NDC 69339-152-17             40 (4x10) unit dose cups            10mL
    NDC 69339-152-19             100 (10x10) unit dose cups        10mL

  • Questions or comments?

    Call 201-786-6500

    Dash Pharmaceuticals LLC
    Upper Saddle River, NJ 07458

    DP-UD-PI-AT-[117894] Rev 08/20

  • PRINCIPAL DISPLAY PANEL

    Delivers 5 mL

    NDC 69339-151-05

    Diphenydramine HCl Oral Solution, USP

    12.5 mg/5 mL

    For Institutional Use Only

    3 69339 15105 1

    Lot # 000000

    Exp: MM/YYY

    See Insert

    DASH Pharmaceuticals LLC

    Upper Saddle River, NJ 07458

    DASH-

    DOSE

    Principal Display Panel

  • PRINCIPAL DISPLAY PANEL

    Delivers 10 mL

    NDC 69339-152-01

    Diphenydramine HCl Oral Solution, USP

    25 mg/10 mL

    For Institutional Use Only

    3 69339 15201 0

    Lot # 000000

    Exp: MM/YYY

    See Insert

    DASH Pharmaceuticals LLC

    Upper Saddle River, NJ 07458

    DASH-

    DOSE

    Principal Display Panel

  • INGREDIENTS AND APPEARANCE
    DIPHENHYDRAMINE HCL ORAL SOLUTION 
    diphenhydramine hydrochloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69339-151
    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
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    SUCROSE (UNII: C151H8M554)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Product Characteristics
    ColorredScore    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69339-151-174 in 1 CASE12/14/2020
    110 in 1 TRAY
    1NDC:69339-151-055 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    2NDC:69339-151-1910 in 1 CASE12/14/2020
    210 in 1 TRAY
    2NDC:69339-151-055 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 DrugM01212/14/2020
    DIPHENHYDRAMINE HCL ORAL SOLUTION 
    diphenhydramine hydrochloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69339-152
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    SUCROSE (UNII: C151H8M554)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Product Characteristics
    ColorredScore    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69339-152-174 in 1 CASE12/14/2020
    110 in 1 TRAY
    1NDC:69339-152-0110 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    2NDC:69339-152-1910 in 1 CASE12/14/2020
    210 in 1 TRAY
    2NDC:69339-152-0110 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 DrugM01212/14/2020
    Labeler - Natco Pharma USA LLC (079590418)
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