Label: PHYSICIANSCARE ALLERGY ANTIHISTAMINE- diphenhydramine hydrochloride tablet, film coated

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated November 9, 2024

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  • ACTIVE INGREDIENT

    Active Ingredients (in each tablet)

    Diphenhydramine Hydochloride 25 mg

  • PURPOSE

    Purpose


    Antihistamine

  • INDICATIONS & USAGE

    Uses

    temporarily relieves these symptoms due to hay fever or other respiratory allergies

    • runny nose
    • sneezing
    • itching nose or throat
    • itchy-watery eyes

    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 that is used on the skin.

    Ask a doctor before use if you have

    • a breathing problem such as emphysema or chronic bronchitis
    • difficuly in urination due to enlargement of the prostate gland
    • glaucoma

    Ask a doctor or pharmacist before use if you are

    • taking sedatives or tranquilizers

    When using this product
    * marked drowsiness may occur and avoid alcoholic beverages
    * alcohol, sedatives and tranquilizers may increase the drowsiness effect
    * use caution 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

    Keep out of the reach of children.

    In case of overdose, contact a physician or poison control center immediately.

  • DOSAGE & ADMINISTRATION

    Directions

    Do not use more than directed


    Adults and children: (12 years and older)

    Take 1 to 2 caplets every 4 to 6 hours as needed. Do not take more than 12 caplets in 24 hours, or as directed by a doctor.

    Children under 12 years:

    Do not give to children under 12 years of age.

  • INFORMATION FOR PATIENTS

    Other information

    • each caplet may contain: calium 25mg
    • store at room temperature 59°-86°F (15°-30°C)
    • protect from light
    • use by expiration date on packet
    • tamper-evident sealed packets
    • do not use any opened or torn packets
  • INACTIVE INGREDIENT

    Inactive ingredients


    carnauba wax*, colloidal silicon dioxide, croscarmellose sodium, D&C red #27, dicalcium phosphate, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80*, titanium dioxide



    *may contain.

  • QUESTIONS

    Questions?

    1-800-835-2263

  • PRINCIPAL DISPLAY PANEL

    BOX16790056-revC.jpg

    Carton 167

  • PRINCIPAL DISPLAY PANEL

    Carton184Box18490036-revC.jpg

  • INGREDIENTS AND APPEARANCE
    PHYSICIANSCARE ALLERGY  ANTIHISTAMINE
    diphenhydramine hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0924-0056(NDC:47682-167)
    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
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    POLYETHYLENE GLYCOL 2000 (UNII: HAF0412YIT)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K)  
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    Product Characteristics
    Colorpink (Pink) Scoreno score
    ShapeOVAL (Oval) Size11mm
    FlavorImprint Code 048;D
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0924-0056-0150 in 1 CARTON11/01/2017
    11 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01211/01/2017
    Labeler - Acme United Corporation (001180207)
    Establishment
    NameAddressID/FEIBusiness Operations
    Acme United Corporation045924339relabel(0924-0056) , repack(0924-0056)
    Establishment
    NameAddressID/FEIBusiness Operations
    Acme United Corporation080119599relabel(0924-0056) , repack(0924-0056)
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