Label: DIPHENHYDRAMINE HYDROCHLORIDE tablet

  • NDC Code(s): 76457-002-00
  • Packager: Simpex Pharma Pvt. Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 29, 2023

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  • Drug Facts

  • Active ingredient (in each tablet)

    Diphenhydramine hydrochloride 25 mg

    Purpose

    Antihistamine

  • Uses

    temporarily relieves symptoms due to common cold, hay fever or other allergies affecting the upper respiratory tract

    • runny nose
    • sneezing
    • Itchy watery eyes
    • 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.

    Consult your doctor if you have

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

    Consult your doctor if you are taking sedatives or tranquilizers

    • sedative, 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 or reach of children.

    In case of overdose, get medical help or contact a poison control center right away.

    When using this product

    • marked drowsiness may occur
    • avoid alcoholic drinks.
  • Directions:

    • take every 4 to 6 hours
    • do not take more than 6 does in 24 hours
    • Adult and children 12 years of age and over - 1 to 2 tablet
    • Children 6 to 12 years of age - 1 tablet
    • Children 6 years of age - do not use this product in children under 6 years
  • Other Information

    • each tablet contains: Calcium 25 mg/tablet
    • store at room temperature 15°-30° (59°-86° F)
    • protect from light and moisture
  • Inactive ingredient

    carnauba wax, colloidal anhydrous silica, croscarmellose sodium, dibasic calcium phosphate, hydroxy propyl methyl cellulose phthalate HP-55, lecithin, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, polysorbate 80, polyvinyl alcohol, talc, titanium dioxide, xanthan gum,

  • Package Labeling:

    Label2

  • INGREDIENTS AND APPEARANCE
    DIPHENHYDRAMINE HYDROCHLORIDE 
    diphenhydramine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76457-002
    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
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    Product Characteristics
    Colorwhite (white) Scoreno score
    ShapeROUND (round) Size8mm
    FlavorImprint Code ;
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76457-002-001 in 1 CARTON02/09/2018
    1100 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01202/09/2018
    Labeler - Simpex Pharma Pvt. Ltd (916758275)
    Registrant - Simpex Pharma Pvt. Ltd (916758275)
    Establishment
    NameAddressID/FEIBusiness Operations
    Simpex Pharma Pvt. Ltd916758275manufacture(76457-002)
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