Label: ALLERGY RELIEF- diphenhydramine hcl tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated August 1, 2024

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

View All Sections
  • Active ingredient (in each tablet)

    Diphenhydramine HCl 25 mg

  • Purpose

    Antihistamine

  • Uses

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

    do not use

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

    ask a doctor before use if you have

    • trouble urinating due to an enlarged prostate gland
    • glaucoma
    • a breathing problem such as emphysema or chronic bronchitis

    ask your doctor or pharmacist before use if you are

    • taking sedatives or tranquilizers.

    When using this product

    • marked drowsiness may occur
    • avoid alcoholic beverages
    • excitability may occur, especially in children
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • be careful when driving a motor vehicle or operating machinery

    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.

    Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • Directions

    • take every 4 to 6 hours, or as directed by a doctor
    • do not take more than 6 doses in 24 hours

    Adults and children 12 years and over:1 or 2 caplets

    Children 6 to under 12 years of age:1 caplet

    Children under 6 years of age: do not use

  • Other information

    • Each caplet contains:Calcium 23.52 mg
    • store at controlled room temperature 20°-25°C (68°-77°F)
    • read all product information before using.
    • TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
  • Inactive ingredients

    Colloidal Silicon Dioxide, Croscarmellose Sodium, D&C Red #27, Dicalcium Phosphate, Lecithin, Magnesium Stearate, Microcrystalline Cellulose, Polyvinyl alcohol, Titanium dioxide, Talc

  • Questions or comments?

    Call toll free 1-800-630-8895

    Monday through Friday 9 AM - 5 PM EST.

  • SPL UNCLASSIFIED SECTION

    Distributed by:

    Advanced Rx LLC

    1942 NE 163rd St North Miami Beach,

    FL 33162 U.S.A.

    MADE IN THE USA

  • PRINCIPAL DISPLAY PANEL

    NDC 80513-722-06

    Compare to Benadryl ®Allergy Ultratab ®active ingredient*

    ALLERGY RELIEF

    DIPHENHYDRAMINE HCl 25 mg

    ANTIHISTAMINE

    RELIEVES:

    Sneezing

    Itchy, Watery Eyes

    Runny Nose

    Itchy Throat

    600

    MINI TABLETS

    *This product is not manufactured or distributed by McNeil-Consumer Healthcare, owner of the registered trademark Benadryl ®Allergy Ultratab ®

    label
  • INGREDIENTS AND APPEARANCE
    ALLERGY RELIEF 
    diphenhydramine hcl tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80513-722
    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)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeOVALSize11mm
    FlavorImprint Code D25
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80513-722-06600 in 1 BOTTLE; Type 0: Not a Combination Product08/01/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01208/01/2024
    Labeler - Advanced Rx LLC (042795108)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!