Label: ALLERGY RELIEF- diphenhydramine hydrochloride tablet, film coated

  • NDC Code(s): 49483-061-01, 49483-061-10, 49483-061-42, 49483-061-62, view more
    49483-061-65
  • Packager: TIME CAP LABORATORIES, INC
  • 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 February 14, 2023

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  • DRUG FACTS

  • ACTIVE INGREDIENT

    Active ingredient (in each caplet)
    Diphenhydramine HCI 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

    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
    • trouble 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

    • 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
  • 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 accidental overdose, get medical help or contact a Poison Control Centre (1-800-222-1222) 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 INFORMATION

    Other information

    • each caplet contains: calcium 25 mg
    • protect from light
    • store at 25 0C (77 0F) excursions permitted between 15 0-30 0C (59 0-86 0F)
    • use by expiration date on package
  • INACTIVE INGREDIENT

    Inactive ingredients carnauba wax, colloidal silicon dioxide, croscarmellose sodium, D&C red no 27 aluminum lke, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol(PEG)400, polysorbate80, titanium dioxide.

  • QUESTIONS

    Questions or comments?call 1-877-290-4008

  • PRINCIPAL DISPLAY PANEL

    160R-timely-365s-label160R-timely-24s-label160R-timely-24s-ifctimely 160R Diphenhydramine HCl 25mg bottle label 650ct
    160label

  • INGREDIENTS AND APPEARANCE
    ALLERGY RELIEF 
    diphenhydramine hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49483-061
    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 ALUMINUM LAKE (UNII: ZK64F7XSTX)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeCAPSULESize11mm
    FlavorImprint Code T061
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49483-061-01100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/17/2018
    2NDC:49483-061-101000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/17/2018
    3NDC:49483-061-62650 in 1 BOTTLE; Type 0: Not a Combination Product05/01/2012
    4NDC:49483-061-421 in 1 CARTON07/30/2021
    424 in 1 BOTTLE; Type 0: Not a Combination Product
    5NDC:49483-061-65365 in 1 BOTTLE; Type 0: Not a Combination Product02/21/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34105/01/2012
    Labeler - TIME CAP LABORATORIES, INC (037052099)
    Registrant - TIME CAP LABORATORIES, INC. (037052099)
    Establishment
    NameAddressID/FEIBusiness Operations
    TIME CAP LABORATORIES, INC037052099manufacture(49483-061)
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