Label: BANOPHEN- diphenhydramine hydrochloride liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated September 17, 2019

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each teaspoonful (5 mL))

    Diphenhydramine HCl USP 12.5 mg

  • Purpose

    Antihistamine

  • Uses

    temporarily relieves these symptoms due to hay fever or other upper 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, including one applied topically.

    Ask a doctor before use if you have

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

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

    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

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

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

  • Directions

    • take every 4 to 6 hours
    • do not take more than 6 doses in 24 hours
    adults and children 12 years and over2 - 4 teaspoonsful (25 mg to 50 mg)
    children 6 to under 12 years1 - 2 teaspoonsful (12.5 mg to 25 mg)
    children 2 to 5 years of agedo not use unless directed by a doctor
    children under 2 years of agedo not use
  • Other information

    • each teaspoonful (5 mL) contains: sodium 7 mg
    • store at room temperature 20°-25°C (68°-77°F)
  • Inactive ingredients

    artificial cherry flavor, citric acid, D&C Red #33, FD&C Red #40, glycerin, polysorbate 20, purified water, sodium benzoate, sodium citrate, sodium saccharin, sorbitol solution

  • Questions or comments?

    (800) 616-2471

  • HOW SUPPLIED

    Product: 17856-5174

    NDC: 17856-5174-2 5 mL in a CUP

    NDC: 17856-5174-1 10 mL in a CUP, UNIT-DOSE

  • BANOPHEN (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID

    Label Image
  • INGREDIENTS AND APPEARANCE
    BANOPHEN 
    diphenhydramine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17856-5174(NDC:0904-5174)
    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
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    Citric Acid Monohydrate (UNII: 2968PHW8QP)  
    Sorbitol (UNII: 506T60A25R)  
    FD&C Red no. 40 (UNII: WZB9127XOA)  
    Glycerin (UNII: PDC6A3C0OX)  
    Polysorbate 20 (UNII: 7T1F30V5YH)  
    Cherry (UNII: BUC5I9595W)  
    Water (UNII: 059QF0KO0R)  
    Sodium Benzoate (UNII: OJ245FE5EU)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    D&C Red no. 33 (UNII: 9DBA0SBB0L)  
    Product Characteristics
    ColorPINKScore    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:17856-5174-272 in 1 CASE09/17/2019
    1 5 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 NOT FINALpart34808/24/2012
    Labeler - Atlantic Biologicals Corps (047437707)
    Establishment
    NameAddressID/FEIBusiness Operations
    Atlantic Biologicals Corps047437707RELABEL(17856-5174) , REPACK(17856-5174)
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