Label: COMPLETE ALLERGY RELIEF- diphenhydramine hcl 25mg tablet

  • NDC Code(s): 67091-381-10, 67091-381-24
  • Packager: WinCo Foods LLC
  • 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 January 6, 2022

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  • DRUG FACTS

  • ACTIVE INGREDIENT

    Active ingredients (in each caplet)
    Diphenhydramine HCl 25 mg

  • PURPOSE

    Purpose
    Antihistamine

  • INDICATIONS & USAGE

    Uses

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

  • WARNINGS

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

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

    When using this product
    • marked drowsiness may occur
    • avoid alcoholic drinks
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • excitability may occur, especially in children
    • 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.

  • DOSAGE & ADMINISTRATION

    Directions
    • take every 4 to 6 hours
    • do not take more than 6 doses in 24 hours
    adults and children 12 years of age and over: 1 to 2 caplets
    children 6 to under 12 years of age: 1 caplet
    children under 6 years of age: do not use this product in children under 6 years of age

  • OTHER SAFETY INFORMATION

    Other information
    • each caplet contains: calcium 25 mg
    • protect from light
    • store at 25°C (77° F) excursions permitted between 15°-30°C (59°-86°F)
    • use by expiration date on package

  • INACTIVE INGREDIENT

    Inactive ingredients carnauba wax, colloidal silicon dioxide, croscarmellose sodium, D&C red #27 aluminum lake, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol (PEG) 400, polysorbate 80, titanium dioxide

  • QUESTIONS

    Questions? Call 1-800-824-1706

    Monday - Friday 9 am-4pm MST

  • PRINCIPAL DISPLAY PANEL

    160R-Winco-Allergy-Relief-bottle-label-100s160R-Winco-Allergy-Relief-carton-label-100s160R-Winco-Allergy-Relief-carton-label-24s

  • INGREDIENTS AND APPEARANCE
    COMPLETE ALLERGY RELIEF 
    diphenhydramine hcl 25mg tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67091-381
    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
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeCAPSULESize11mm
    FlavorImprint Code T;061
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67091-381-241 in 1 CARTON01/15/2022
    124 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:67091-381-101 in 1 CARTON01/15/2022
    2100 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34101/15/2022
    Labeler - WinCo Foods LLC (056098817)
    Registrant - TIME CAP LABORATORIES, INC. (037052099)
    Establishment
    NameAddressID/FEIBusiness Operations
    TIME CAP LABORATORIES, INC.037052099manufacture(67091-381)
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