Label: BANOPHEN- diphenhydramine hcl liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 1, 2024

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

View All Sections
  • Active ingredient (in each 5 mL)*

    Diphenhydramine HCl 12.5 mg

    *5 mL = 1 teaspoon (tsp)

  • Purpose

    Antihistamine

  • Uses

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

    Do not use

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

    Ask a doctor before use if the child has

    •
    a breathing problem such as chronic bronchitis
    •
    glaucoma
    •
    a sodium-restricted diet

    Ask a doctor or pharmacist before use if the child is

    taking sedatives or tranquilizers

    When using this product

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

    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

    •
    find right dose on chart below
    •
    use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.
    •
    take every 4 to 6 hours
    •
    do not take more than 6 doses in 24 hours

    Age (yr)

    Dose

    children under 2 years

    do not use

    children 2 to 5 years

    do not use unless directed by a doctor

    children 6 to 11 years

    5 to 10 mL (1 to 2 tsp)

    Attention: use only enclosed dosing cup designed for use with this product. Do not use any other dosing device

  • Other information

    •
    each teaspoon contains: sodium 15 mg
    •
    store at 20-25°C (68-77°F)
  • Inactive ingredients

    anhydrous citric acid, D&C red #33, FD&C red #40, flavor, glycerin, high fructose corn syrup, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate, sorbitol solution

  • Questions or comments?

    1-800-616-2471

  • Principal Display Panel

    63187-315-04
  • INGREDIENTS AND APPEARANCE
    BANOPHEN 
    diphenhydramine hcl liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63187-315(NDC:0904-1228)
    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)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    SORBITOL (UNII: 506T60A25R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Product Characteristics
    ColorRED (Bluish-Red) Score    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63187-315-041 in 1 CARTON02/02/2015
    1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01211/20/2006
    Labeler - Proficient Rx LP (079196022)
    Establishment
    NameAddressID/FEIBusiness Operations
    Proficient Rx LP079196022RELABEL(63187-315)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!