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

  • 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 May 5, 2023

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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:

    FD&C Red# 40, flavors, geleol mono and diglycerides, glucose syrup, gum arabic, hydroxypropyl betadex, maltitol solution, neotame, polyethylene glycol 400, povidone K30, propylene glycol, purified water, seaweed extract (carrageenan), sodium chloride, starch, sucralose, sucrose, trisodium citrate dihydrate.

  • SPL UNCLASSIFIED SECTION

    Questions or comments?

    Call 1-800-227-6151

  • SPL UNCLASSIFIED SECTION

    USpharma

    13900 NW 57th Court, Miami Lakes, FL 33014

    1-800-227-6151  www.uspharmaltd.com

  • Principal display Panel-25 mg Bottle label

    FIRSTCARE                        NDC 71594-708-08

    ***MADE IN USA***         Patent Pending

    ALLERGY RELIEF Diphenhydramine HCl 25 mg  Antihistamine

    Gummy Bite       Mixed Berry Flavor

    Relief of:

    • Sneezing
    • Runny nose
    • Itchy, Watery eyes
    • Itchy Throat

    20 PIECES

    Principal display Panel-25 mg Bottle label

  • INGREDIENTS AND APPEARANCE
    FIRSTCARE ALLERGY RELIEF DIPHENHYDRAMINE HCI, 25 MG ANTIHISTAMINE 
    diphenhydramine hcl bar, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71594-708
    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
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    CORN SYRUP (UNII: 9G5L16BK6N)  
    ACACIA (UNII: 5C5403N26O)  
    HYDROXYPROPYL BETADEX (UNII: 1I96OHX6EK)  
    GLYCERYL MONO AND DIPALMITOSTEARATE (UNII: KC98RO82HJ)  
    MALTITOL (UNII: D65DG142WK)  
    NEOTAME (UNII: VJ597D52EX)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POVIDONE K30 (UNII: U725QWY32X)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    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
    FlavorBERRY (Mixed Berry) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71594-708-0820 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/03/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34104/14/2023
    Labeler - USpharma Ltd (080664601)
    Establishment
    NameAddressID/FEIBusiness Operations
    USpharma Ltd080664601manufacture(71594-708)
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