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

Drug Label Information

Updated December 11, 2023

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 Label
  • 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 ALUMINUM LAKE (UNII: ZK64F7XSTX)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    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 Product04/28/201612/01/2026
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01204/28/201612/01/2026
    Labeler - New World Imports, Inc (075372276)