Label: ALLERGY RELIEF ANTIHISTAMINE- diphenhydramine hcl tablet

  • 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 19, 2021

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

  • 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
    • itching nose or throat

    temporarily relieves these symptoms of 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 have

    taking sedatives or tranquilizers.

    When using this product

    • marked 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

    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, or as directed by a doctor 
    • do not more than 6 doses in 24 hours
     adults and children 12 years and over take 1 to 2 tablets 
     children 6 to under 12 years  take 1 tablet
    children under 6 yearsdo not use
  • Other information

    • each tablet contains: calcium 25 mg
    • store between 20-25°C (68-77°F)
    • protect from light and moisture
  • Inactive ingredients

    carnauba wax, colloidal silicon dioxide, croscarmellose sodium, D&C Red #27 Aluminum Lake, dibasic calcium phosphate dihydrate, hypromellose, lecithin*, magnesiun stearate, microcrystalline cellulose, polyethylene glycol (PEG) 400, polysorbate 80, polyvinyl alcohol*, purified water*, talc*, titanium dioxide.

    *contains one or more of these ingredients

  • Questions or Comments?

    Call 1-877-753-3935 Monday- Friday 9AM-5PM EST

  • Principal Display Panel

     ALLERGY RELIEF

    Diphenhydramine HCl 25 mg-Antihistamine

    Relieves:

    • Sneezing
    • Runny Nose
    • Itchy Nose or Throat
    • Itchy, Watery Eyes

    Compare To The Active Ingredient in Benadryl® Allergy**

    **This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Benadryl® Allergy.

    TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

    DISTRIBUTED BY: fred's, Inc.

    4300 NEW GETWELL, RD, MEMPHIS, TN 38118

    www.fredsinc.com

  • Product Label

    Diphenhydramine HCI 25 mg

    Fred's Pharmacy Allergy Relief

  • INGREDIENTS AND APPEARANCE
    ALLERGY RELIEF  ANTIHISTAMINE
    diphenhydramine hcl tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55315-690
    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
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    WATER (UNII: 059QF0KO0R)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeCAPSULESize11mm
    FlavorImprint Code T61;V25;S4
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55315-690-011 in 1 BOX07/22/201001/26/2024
    1100 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33607/22/201001/26/2024
    Labeler - Freds Inc (005866116)