Label: ALLERGY RELIEF DIPHENHYDRAMINE HCI 25 MG ANTIHISTAMINE- diphenhydramine hcl bar, chewable

  • NDC Code(s): 70677-0162-1
  • Packager: Strategic Sourcing Services LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 June 22, 2022

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  • Active ingredient (in each piece)

    Diphenhydramine HCl 25 mg

  • Purpose

    Antihistamine

  • Uses

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

    Do not use

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

    Ask a doctor before use if you have

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

    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 reach of children.

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

  • Directions

    • take every 4 to 6 hours, or as directed by a doctor
    • do not take more than 6 times in 24 hour                                                                                                                                                   

      Age (yr)

      Dose (Piece)

      Adults and children 12 years and over

      1 to 2 Pieces (25 mg to 50 mg)

      Children 6 to 11 years

      1 Piece (25 mg)

      Children under 6 years

      Do not use
  • SPL UNCLASSIFIED SECTION

    Other information

    • each piece contains sodium 9 mg.

        low sodium

    • store in a cool dry place between 20-25°C (68-77°F).
    • Child Resistant Container; do not use if printed seal under cap is broken or missing.
  • Inactive ingredients:

    citric acid, FD&C red #40, flavor, glucose syrup, hydroxypropyl betadex, magnesium stearate,maltitol solution, maltodextrin, neotame, purified water, seaweed extract (carrageenan), sodium chloride, starch, sucralose, sucrose, trisodium citrate dihydrate.

  • SPL UNCLASSIFIED SECTION

    Questions or comments?

    Call 833-358-6431

    Monday to Friday 9:00am to 7:00pm EST

  • Principal display Panel-25 mg carton label

    sunmark

    COMPARE TO BENADRYL® ALLERGY active ingredient

    NDC 70677-1062-1

    Soft Chews

    allergy relief Diphenhydramine HCl, 25 mg | Antihistamine

    Allergy Relief for:                    

    Sneezing                                            

    Runny Nose                                       

    Itchy, Watery Eyes                          

    Itchy Throat 

    Bubble Gum Flavor

    Chewy Bites

    Actual Size         10 PIECES

    Principal display Panel-25 mg carton label

  • INGREDIENTS AND APPEARANCE
    ALLERGY RELIEF DIPHENHYDRAMINE HCI 25 MG ANTIHISTAMINE 
    diphenhydramine hcl bar, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70677-0162
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    CORN SYRUP (UNII: 9G5L16BK6N)  
    HYDROXYPROPYL BETADEX (UNII: 1I96OHX6EK)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTITOL (UNII: D65DG142WK)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    NEOTAME (UNII: VJ597D52EX)  
    WATER (UNII: 059QF0KO0R)  
    CARRAGEENAN (UNII: 5C69YCD2YJ)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SUCROSE (UNII: C151H8M554)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    Product Characteristics
    Colorpink (Light pink to red pink) Scoreno score
    ShapeRECTANGLESize23mm
    FlavorBUBBLE GUMImprint Code o
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70677-0162-11 in 1 CARTON06/22/2022
    110 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34106/22/2022
    Labeler - Strategic Sourcing Services LLC (116956644)
    Establishment
    NameAddressID/FEIBusiness Operations
    USpharma Ltd080664601manufacture(70677-0162)
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