Label: ALLERGY RELIEF- diphenhydramine hydrochloride tablet

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

Drug Label Information

Updated January 12, 2024

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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 youaretaking 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 27, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, titanium dioxide, talc

  • Questions or Comments

    Questions ? call toll-free 1-844-912-4012

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    ITEM# PCOTC124
    Distributed by:
    ProCure Products
    Santa Fe Springs, CA 90670
    MADE IN THE U.S.A.

    Allergy Relief

  • INGREDIENTS AND APPEARANCE
    ALLERGY RELIEF 
    diphenhydramine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55681-322
    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)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeCAPSULESize11mm
    FlavorImprint Code I3
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55681-322-03300 in 1 BOTTLE; Type 0: Not a Combination Product07/15/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01207/15/2022
    Labeler - TWIN MED LLC (009579330)
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