Label: EASY CARE FIRST AID DIPHENHYDRAMINE- diphenhydramine hydrochloride tablet, film coated

  • Category: HUMAN OTC DRUG LABEL

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Drug Label Information

Updated October 3, 2019

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each caplet)

    Diphenhydramine Hydrochloride 25 mg

  • Purpose

    Antihistamine

  • 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

    Do not use

    • to make a child sleepy
    • with any other product containing diphenhydramine, even one that is used on skin.

    Ask a doctor before use if you have

    • a breathing problem such as emphysema or chronic bronchitis
    • difficulty 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
    • avoid alcohol 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 the reach of children.

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

  • 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.

  • Other information

    • each caplet may contain: calcium 25mg
    • protect from light
    • use by expiration date on packet
    • store at room temperature 59º-86ºF (15º-30ºC
    • tamper-evident sealed packets
    • do not use any opened or torn packets
  • 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

  • Easy Care First Aid Diphenhydramine

    1 Caplet

    Made in USA

    See card for complete product information

    Diphenhydramine

  • INGREDIENTS AND APPEARANCE
    EASY CARE FIRST AID DIPHENHYDRAMINE 
    diphenhydramine hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:44224-0017
    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)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE (UNII: J2B2A4N98G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Colorpink (pink) Scoreno score
    ShapeOVAL (OVAL) Size11mm
    FlavorImprint Code 048;D
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:44224-0017-250 in 1 BOX01/01/2012
    11 in 1 PACKET; Type 0: Not a Combination Product
    2NDC:44224-0017-11 in 1 PACKET; Type 0: Not a Combination Product01/01/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34101/01/2012
    Labeler - Tender Corporation (064437304)
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