Label: ALLERGY RELIEF- diphenhydramine hydrochloride tablet

  • Category: HUMAN OTC DRUG LABEL

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 February 27, 2022

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  • 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 a doctor or pharmacist before use if youare taking sedatives or tranquilizers

    When using this product

    • marked drowsiness may occur
    • avoid alcoholic drinks
    • 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 accidental overdose, contact a doctor or Poison Control Center immediately. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
    Do not exceed recommended dosage.

  • Directions

    • take every 4 to 6 hours, not more than 6 doses in 24 hours
    • Adults and children 12 years of age and older: 1 or 2 tablets
    • children 6 to under 12 years of age: 1 tablet
    • children 4 to under 6 years of age: do not use unless directed by a doctor
    • children under 4 years of age: do not use
  • Other Information

    • each tablet contains : calcium 20 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, Dicalcium Phosphate, D & C Red, Magnesium stearate, Microcrystalline cellulose, Polyvinyl alcohol, Titanium dioxide, Talc

  • Questions or Comments

    1-844-384-3723 (Mon-Fri 9AM-5PM EST) or www.safrelpharma.com

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    DIPHENHYDRAMINE HYDROCHLORIDE TABLET

    , USP 25 MG

    ANTIHISTAMINE

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

    71309-109-10 100 Caplets

    100 ct

    71309-109-06 600 Caplets

    600 ct

    71309-109-01 1000 Caplets

    1000 ct

  • INGREDIENTS AND APPEARANCE
    ALLERGY RELIEF 
    diphenhydramine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71309-009
    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)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POLYVINYL ALCOHOL (UNII: 532B59J990)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeCAPSULESize11mm
    FlavorImprint Code EL
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71309-009-301 in 1 CARTON01/01/2016
    130 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:71309-009-10100 in 1 BOTTLE; Type 0: Not a Combination Product05/12/2012
    3NDC:71309-009-011000 in 1 BOTTLE; Type 0: Not a Combination Product05/12/2012
    4NDC:71309-009-06600 in 1 BOTTLE; Type 0: Not a Combination Product05/12/2012
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34105/12/2012
    Labeler - Safrel Pharmaceuticals, LLC. (080566287)
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