Label: ALLERGY RELIEF- diphenhydraime hcl tablet, film coated

  • NDC Code(s): 68210-4169-3
  • Packager: Spirit Pharmaceuticals LLC
  • 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 16, 2021

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  • Drug Facts

  • Purpose

    Antihistamine

  • Active Ingredient


    Diphenhydramine HCl 25 mg

  • Uses

    • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies • runny nose • sneezing • itchy, watery eyes • itching of the nose or throat • 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 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

  • If pregnant or breast-feeding,

    ask a health professional before use.

  • Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

  • Directions

    take every 4 to 6 hours do not take more than 6 doses in 24 hours

     adults & children 12 years & over1 to 2 tablets 
     children 6 to under 12 years1 tablet
     children under 6 yearsdo not use this product in children under 6 years of age

  • Other information

    • each tablet contains: calcium 24 mg • store between 15–30°C (59–86°F) • protect from moisture and light

  • Inactive ingredients

    Colloidal silicon dioxide, croscarmellose sodium, dicalcium phosphate, D&C Red No. 27 Aluminum lake, lecithin, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide

  • Questions or comments?

    1-888-333-9792

  • Distributed by:

    CABINET HEALTH P.B.C.

  • Pouch Label

    PACKAGE NOT CHILD-RESISTANT

    CABINET

    Allergy Relief

    Active Ingredient
    Diphenhydramine HCl 25 mg**

    **May cause drowsiness

    Relieves:
    Sneezing
    Itchy, Watery Eyes
    Runny Nose
    Itchy Throat

    Includes:

    1 x Magnetic Label

    1 x Drug Facts Booklet

    30 x Tablets

    CABINET: The Sustainable Healthcare Co.™

    Pouch


  • INGREDIENTS AND APPEARANCE
    ALLERGY RELIEF 
    diphenhydraime hcl tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68210-4169
    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
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    DICALCIUM CITRATE (UNII: LGH2B6RC26)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeCAPSULESize11mm
    FlavorImprint Code S4
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68210-4169-330 in 1 POUCH; Type 0: Not a Combination Product11/16/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34111/16/2021
    Labeler - Spirit Pharmaceuticals LLC (179621011)
    Registrant - Spirit Pharmaceuticals LLC (179621011)
    Establishment
    NameAddressID/FEIBusiness Operations
    Elysium Pharmaceuticals Ltd915664486manufacture(68210-4169)
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