Label: ALLERGY- diphenhydramine hydrochloride tablet, film coated

  • NDC Code(s): 41226-160-01, 41226-160-40, 41226-160-42
  • Packager: Kroger Company
  • 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 April 12, 2021

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  • DRUG FACTS

  • ACTIVE INGREDIENT

    Diphenhydramine HCl 25 mg

  • 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 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 ot children. In case of overdose, get medical help or contact a Poison Control Center right away(l-800-222-1222).

  • 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°C (77°F) excursions permitted 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 or comments?

    1-800-632-6900

  • PRINCIPAL DISPLAY PANEL

    Allergy 400ct Carton

    Allergy 400ct Carton

    Allergy 400ct Label

    Allergy 400ct label

    Allergy 100ct Carton

    Allergy 100ct Carton

    Allergy 100ct label

    Allergy 100 label

    Allergy 24ct Carton

    Allergy 24ct Carton

  • INGREDIENTS AND APPEARANCE
    ALLERGY 
    diphenhydramine hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41226-160
    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
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeCAPSULESize11mm
    FlavorImprint Code T;061
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41226-160-421 in 1 CARTON05/11/2021
    112 in 1 BLISTER PACK
    112 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:41226-160-401 in 1 CARTON05/11/2021
    2400 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:41226-160-011 in 1 CARTON05/11/2021
    3100 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34105/11/2021
    Labeler - Kroger Company (006999528)
    Registrant - TIME CAP LABORATORIES, INC. (037052099)
    Establishment
    NameAddressID/FEIBusiness Operations
    TIME CAP LABORATORIES, INC.037052099manufacture(41226-160)
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