Label: FIRSTCARE CHILDRENS ALLERGY RELIEF- 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 21, 2020

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  • Active ingredient (in each soft chew)

    Diphenhydramine HCl 12.5 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
  • 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

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

    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 hours
    • Instruct child to chew each soft chew thoroughly before swallowing
    • find right dose on chart below

      Age (yr)

      Dose (soft chew)

      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

      1 to 2 soft chews (12.5 mg to 25 mg)

      Adults and children 12 years and over            

      2 to 4 soft chews (25 mg to 50 mg)
  • SPL UNCLASSIFIED SECTION

    Other information

    • each soft chew contains sodium 7 mg.

          very 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, flavor, glucose syrup, hydroxypropyl betadex, magnesium stearate, maltitol solution, maltodextrin, mineral oil, neotame, purified water, seaweed extract (carrageenan), sodium chloride, starch, sucralose, sucrose, trisodium citrate dehydrate.

  • SPL UNCLASSIFIED SECTION

    Questions or comments?

    Call 1-800-227-6151

  • Package/Label Principal Display Panel

    FIRSTCARETM

    ***MADE IN USA***

    20 Bubble Gum Flavored Soft Chews

    CHILDEREN'S ALLERGY RELIEF

    Diphenhydramine HCl Anthihistamine 12.5 mg Soft Chews

    Runny Nose & Sneezing
    Itchy throat or Nose
    Itchy, Water Eyes
    CHEWY GUMMY BITES

    NDC 71594-705-08        Patent Pending

    bottle label

  • INGREDIENTS AND APPEARANCE
    FIRSTCARE CHILDRENS ALLERGY RELIEF 
    diphenhydramine hcl bar, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71594-705
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    NEOTAME (UNII: VJ597D52EX)  
    CORN SYRUP (UNII: 9G5L16BK6N)  
    CARRAGEENAN (UNII: 5C69YCD2YJ)  
    MALTITOL (UNII: D65DG142WK)  
    HYDROXYPROPYL BETADEX (UNII: 1I96OHX6EK)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    SUCROSE (UNII: C151H8M554)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    WATER (UNII: 059QF0KO0R)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    Coloryellow (Light yellow to golden brown) Scoreno score
    ShapeRECTANGLESize18mm
    FlavorBUBBLE GUMImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71594-705-0820 in 1 BOTTLE; Type 0: Not a Combination Product05/21/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34105/21/2020
    Labeler - USpharma Ltd (080664601)
    Registrant - USpharma Ltd (080664601)
    Establishment
    NameAddressID/FEIBusiness Operations
    USpharma Ltd080664601manufacture(71594-705) , pack(71594-705)
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