Label: CAREALL DIPHENHYDRAMINE- diphenhydramine hydrochloride tablet, coated

  • NDC Code(s): 51824-056-01
  • Packager: New World Imports, 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 October 1, 2019

If you are a consumer or patient please visit this version.

  • Active Ingredient

     Diphenhydramine HCl 25mg

  • Purpose

    Antihistamine

  • Keep out of reach of children

    In case of accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) immediately.

  • Uses

    Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

    Sneezing, runny nose, itchy / watery eyes, and itching of the nose or throat

    Temporarily relieves these symptoms associated with the common cold:

    Sneezing, runny nose

  • Warnings

    Do not use with any other products containing diphenhydramine, including ones 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 beverages

    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

  • Directions

    Take every 4 to 6 hours, or as directed by a doctor.  Do not take more than 6 times in 24 hours

    Adults and children 12 years of age and older: 1 to 2 caplets

    Children 6 to 12 years: 1 caplet

    Children under 6: do not use

  • Inactive Ingredients

    croscarmellose sodium, D C Red 27 aluminum lake, hypromellose, lactose, magnesium stearate, microcystalline cellulose, polyethylene glycol, silicon dioxide, titanium dioxide

  • PRINCIPAL DISPLAY PANEL

    DHC25 Image.jpg

  • INGREDIENTS AND APPEARANCE
    CAREALL DIPHENHYDRAMINE 
    diphenhydramine hydrochloride tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51824-056
    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)  
    HYDROXYMETHYL CELLULOSE (UNII: 273FM27VK1)  
    LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
    Magnesium Stearate (UNII: 70097M6I30)  
    Cellulose, Microcrystalline (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Titanium Dioxide (UNII: 15FIX9V2JP)  
    Product Characteristics
    Colorpink (Bright Pink) Scoreno score
    ShapeOVAL (Oval in Shape, sides straight, top and bottom rounded) Size11mm
    FlavorImprint Code 048;D
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51824-056-01100 in 1 BOTTLE; Type 0: Not a Combination Product04/28/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34104/28/2016
    Labeler - New World Imports, Inc (075372276)