Label: ALLERGY- diphenhydramine hcl tablet tablet

  • NDC Code(s): 66715-9711-7
  • Packager: Lil' Drug Store Products, 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 August 1, 2022

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  • Drug Facts

  • Active Ingredient

    Active ingredient (in each tablet)
    Diphenhydramine HCl 25 mg

  • Purpose

    Anrihistamine

  • 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
    • temporarily relieves these symptoms due to the common cold
    • runny nose
    • sneezing
  • Warnings

    ​Warnings

    Do not use

    • to make a 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 right away (1-800-222-1222).

  • Directions

    • take every 4 to 6 hours, or as directed by a doctor
    • do not take more than 6 doses in 24 hours
    • adults and children 12 years and over take 1 to 2 tablets
    • children 6 to under 12 years take 1 tablet
    • children under 6 years do not use
  • Other information

    • each tablet may contain: calcium 25mg
    • store at room temperature 68º-77ºF (20º-25ºC)
    • protect from light and moisture
  • Inactive ingredients

    colloidal silicon dioxide, croscarmellose sodium, D&C red #27, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide

  • Questions or comments?

    call toll-free 1-877-507-6516 (M-F 8AM – 4:30PM CST)

  • Principal Display Panel

    Allergy

    Diphenhydramine HCl 25 mg

    Antihistamine

    Relieves

    • Runny Nose • Sneezing

    • Itchy, Watery Eyes

    • Itchy Nose or Throat

    50 PACKETS OF 2 CAPLETS

    [UPC]

    3 66715 97117 3

    PDP

    Pouch

  • INGREDIENTS AND APPEARANCE
    ALLERGY 
    diphenhydramine hcl tablet tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66715-9711
    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
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeCAPSULESize12mm
    FlavorImprint Code AZ048
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66715-9711-750 in 1 BOX, UNIT-DOSE09/12/2014
    12 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34109/12/2014
    Labeler - Lil' Drug Store Products, Inc. (093103646)
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