Home > Pill Identifier > Diphenhydramine Hydrochloride 25 MG Oral Tablet

Pill Identifier Information of Diphenhydramine Hydrochloride 25 MG Oral Tablet

Drug Information

Diphenhydramine Hydrochloride 25 MG Oral Tablet

Imprint: T061
Shape: C48336
Color: C48328
Ingredients: Diphenhydramine
Size: 11.00
Score: 1
Rxtty: SCD
Author: TIME CAP LABORATORIES, INC
Inactive Ingredients: CARNAUBA WAX / SILICON DIOXIDE / CROSCARMELLOSE SODIUM / D&C RED NO. 27 / DIBASIC CALCIUM PHOSPHATE DIHYDRATE / HYPROMELLOSES / MAGNESIUM STEARATE / CELLULOSE, MICROCRYSTALLINE / POLYETHYLENE GLYCOL 400 / POLYSORBATE 80 / TITANIUM DIOXIDE>

Complete Information

  • 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 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 25ËšC (77ËšF) excursions permitted between 15Ëš-30ËšC (59Ëš-86ËšF)
    • use by expiration date on package
  • INACTIVE INGREDIENT

    Inactive ingredients carnauba wax, colloidal silicon dioxide, croscarmellose sodium, D&C red no 27 aluminum lake, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol(PEG) 400, polysorbate 80, titanium dioxide

  • QUESTIONS

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

  • PRINCIPAL DISPLAY PANEL

    160R-24ct IFC

    160R-24ct label

    160R-100ct IFC

    160R-100ct label

    160R-365ct label

  • 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)  
    HYPROMELLOSE, UNSPECIFIED (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 DrugM01205/01/2012
    Labeler - TIME CAP LABORATORIES, INC (037052099)
    Registrant - TIME CAP LABORATORIES, INC. (037052099)
    Establishment
    NameAddressID/FEIBusiness Operations
    TIME CAP LABORATORIES, INC037052099manufacture(49483-061)
    Establishment
    NameAddressID/FEIBusiness Operations
    MARKSANS PHARMA LIMITED677604129manufacture(49483-061)
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