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

  • 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 November 17, 2017

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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 finalpart34111/01/2017
    PHYSICIANSCARE ALLERGY  ANTIHISTAMINE
    diphenhydramine hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0924-0036(NDC:47682-184)
    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 061;T
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0924-0036-0150 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 finalpart34111/01/2017
    Labeler - Acme United Corporation (001180207)
    Establishment
    NameAddressID/FEIBusiness Operations
    Acme United Corporation045924339relabel(0924-0056, 0924-0036) , repack(0924-0056, 0924-0036)
    Establishment
    NameAddressID/FEIBusiness Operations
    Acme United Corporation080119599relabel(0924-0056, 0924-0036) , repack(0924-0056, 0924-0036)
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