Label: ALLERGY- diphenhydramine hydrochloride capsule

  • NDC Code(s): 56062-462-62, 56062-462-67
  • Packager: Publix Super Markets 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 January 3, 2019

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  • Active ingredient (in each capsule)

    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
    •
    itching of the nose or throat
    •
    temporarily relieves these symptoms due to the common cold:
    •
    runny nose
    •
    sneezing
  • 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

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

    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
    •
    be careful when driving a motor vehicle or operating machinery
    •
    excitability may occur, especially in children

    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 (1-800-222-1222).

  • Directions

    •
    take every 4 to 6 hours, or as directed by a doctor
    •
    do not take more than 6 doses in 24 hours

    adults and children 12 years and over

    1 to 2 capsules

    children 6 to under 12 years

    1 capsule

    children under 6 years

    do not

  • Other information

    •
    store at 20-25°C (68-77°F). Avoid high humidity. Protect from light.
    •
    each capsule is sealed with a Uni Band® seal which bonds the two capsule halves together. Do not use if seal is broken or missing. Do not use if blister unit is broken or torn.
  • Inactive ingredients

    anhydrous lactose, benzyl alcohol, butylparaben, D&C red no. 28, edetate calcium disodium, edible ink, FD&C blue no. 1, FD&C red no. 40, gelatin, magnesium stearate, methylparaben, polysorbate 80, propylparaben, sodium lauryl sulfate, sodium propionate

  • Principal Display Panel

    allergy capsules

    DIPHENHYDRAMINE HCI 25 mg

    ANTIHISTAMINE

    Relieves:

    Sneezing

    Itchy, watery eyes

    Runny nose

    Itchy throat

    ACTUAL SIZE

    48 CAPSULES

    Compare to the active ingredient in Benadryl®

    allergy image
  • INGREDIENTS AND APPEARANCE
    ALLERGY 
    diphenhydramine hydrochloride capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:56062-462
    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
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    D&C RED NO. 28 (UNII: 767IP0Y5NH)  
    EDETATE CALCIUM DISODIUM (UNII: 25IH6R4SGF)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GELATIN (UNII: 2G86QN327L)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM PROPIONATE (UNII: DK6Y9P42IN)  
    Product Characteristics
    ColorPINK (clear) , WHITE (clear) , RED (band) Scoreno score
    ShapeCAPSULESize14mm
    FlavorImprint Code L462
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:56062-462-6224 in 1 CARTON08/31/1993
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:56062-462-6748 in 1 CARTON04/18/2002
    21 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34108/31/1993
    Labeler - Publix Super Markets Inc (006922009)
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