Label: ALLERGY RELIEF- diphenhydramine hcl 25 mg tablet

  • NDC Code(s): 72090-021-60
  • Packager: Pioneer Life Sciences, LLC
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated October 18, 2023

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • Active Ingredient (in each tablet)

    Diphenhydramine Hcl 25mg

  • Purpose

    Antihistamine

  • 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 DOCTOR

    Ask a doctor before use if you have

    • glaucoma
    • troble urinating due to an enlarged prostate gland 
    • a breathing problem such as emphysema or chronic bronchitis
  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

  • WHEN USING

    When using this product ■ drowsiness may occur ■avoid alcoholic drinks ■alcohol, sedatives, and tranquilizers may increase drowsiness ■be careful when driving a motor vehicle or operating machinery ■excitability may occur, especially in children.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

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

  • DIRECTIONS

    ■If needed, repeat dose every 4 to 6 hours

    ■ do not take more than 6 times in 24 hours.

    ■Adults and children 12 years and over: Take 1 to 2 tablets

    ■ Children 6 to under 12 years: 1 tablet

    ■Children under 6 years: Do not use this product for children under 6 years of age.

  • OTHER INFORMATION

    Each tablet contains: ■Calcium 24mg ■Store between 20º-25ºC (68º-77ºF). Avoid high humidity. Protect from moisture and light.

  • INACTIVE INGREDIENTS

    Dicalcium Phosphate, Microcrystalline Cellulose, Croscarmellose Sodium, Colloidal Silicon Dioxide, Magnesium Stearate, Opadry-II 85G540006 Pink

  • QUESTIONS OR COMMENTS?

    Call 1-732-698-5070 Monday through Friday 9 AM to 5 PM EST or www.pioneerlifesciences.com

  • PACKAGE LABEL

    PL0060 Rev 00 Diphenhydramine-600ct-08.04.22-ELYSIUM-PRINT

  • INGREDIENTS AND APPEARANCE
    ALLERGY RELIEF 
    diphenhydramine hcl 25 mg tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72090-021
    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
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeOVALSize11mm
    FlavorImprint Code S4
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72090-021-60600 in 1 BOTTLE; Type 0: Not a Combination Product06/29/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01206/29/2020
    Labeler - Pioneer Life Sciences, LLC (014092742)