Label: DRX CHOICE CHILDRENS ALLERGY CHEWS- diphenhydramine hcl tablet, chewable

  • NDC Code(s): 68163-012-48
  • Packager: RARITAN PHARMACEUTICALS INC
  • 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 September 2, 2023

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  • Active ingredient (in each tablet)

    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 a child sleepy
    ▪
    with any other product containing diphenhydramine, even one used on skin

    Ask your doctor before use if you have

    ▪
    glaucoma
    ▪
    a breathing problem such as emphysema or chronic bronchitis
    ▪
    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 right away at 1-800-222-1222

  • Directions

    ▪
    chew one tablet completely at the onset of symptoms. Do not swallow tablets whole.
    ▪
    Find right dose on chart below
    ▪
    take every 4 to 6 hours, or as directed by a doctor
    ▪
    do not take more than 6 doses in 24 hours

    Age (Yr)

    Dose (chewable tablets)

    children under 2 years of age

    do not use 

    children 2 to under 5 years of age

    do not use unless directed by a doctor 

    children 6 to under 12 years of age 

    1 to 2 tablets 

    adults and children 12 years of age and over

    2 to 4 tablets
  • Other information

    ▪
    store below at room temperature. Avoid high humidity. Protect from light.
  • Inactive ingredients

    citric acid, crospovidone, D&C Red No.30, dextrose, FD&C Blue No 1, flavors, magnesium stearate, maltodextrin, potassium citrate, silica, sodium polystyrene sulfonate, starch, sucralose

  • Questions or comments ?

     1-866-467-2748

  • Principal Display Panel

    NDC 68163-012-48

    Compare to active ingredient in Children's Benadryl® Allergy Chewable Tablets

    DRx Choice

    children's allergy chews
    diphenhydramine HCl, 12.5 mg/ antihistamine

    For Relief of:

    •
    Sneezing
    •
    Runny nose
    •
    Itchy throat or Nose
    •
    Itchy, watery eyes

    48 Chewable Tablets

    Grape Flavor

    4-6 HOURS/DOSE

    TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

    *This product is not manufactured or distributed by Johnson & Johnson Consumer INC, owner of the registered trademark Children's Benadryl® Allergy Chewable Tablets.

    Manufactured by:

    Raritan Pharmaceuticals

    8 Joanna Court,

    East Brunswick,

    NJ 08816

    IMPORTANT: Keep this carton for future reference on full labelling

    DRx Choice Children's allergy Chews 48 Tablets
  • INGREDIENTS AND APPEARANCE
    DRX CHOICE CHILDRENS ALLERGY CHEWS 
    diphenhydramine hcl tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68163-012
    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
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    CROSPOVIDONE (120 .MU.M) (UNII: 68401960MK)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    POTASSIUM CITRATE (UNII: EE90ONI6FF)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM POLYSTYRENE SULFONATE (UNII: 1699G8679Z)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    ColorPURPLEScore2 pieces
    ShapeROUNDSize16mm
    FlavorGRAPEImprint Code RP012
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68163-012-484 in 1 CARTON07/04/2022
    112 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34107/04/2022
    Labeler - RARITAN PHARMACEUTICALS INC (127602287)
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