Label: ALLERGY- diphenhydramine hydrochloride capsule

  • NDC Code(s): 41250-462-62, 41250-462-67, 41250-462-78
  • Packager: Meijer Distribution 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 November 13, 2020

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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

    with any other product containing diphenhydramine, even one used on skin
    to make a child sleepy

    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 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
    do not take more than 6 doses in 24 hour

    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 use

  • 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

  • Questions or comments?

    1-800-719-9260

  • Principal Display Panel

    Compare to Benadryl® active ingredient

    MULTI-SYMPTOM

    allergy capsules

    Diphenhydramine HCl 25 mg | Antihistamine

    RELIEF OF:

    Sneezing; Itchy, Watery Eyes; Runny Nose & Itchy Throat

    24 Capsules | actual size

    462-6e-allergy-capsules-1.jpg
    462-6e-allergy-capsules-2.jpg
  • INGREDIENTS AND APPEARANCE
    ALLERGY 
    diphenhydramine hydrochloride capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41250-462
    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, UNSPECIFIED (UNII: 2G86QN327L)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    Product Characteristics
    ColorPINK (clear) , WHITE (clear) , RED (band) Scoreno score
    ShapeCAPSULESize14mm
    FlavorImprint Code L462
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41250-462-6224 in 1 CARTON01/15/1991
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:41250-462-6748 in 1 CARTON01/15/199110/12/2016
    21 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:41250-462-781 in 1 CARTON01/15/1991
    3100 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34101/15/1991
    Labeler - Meijer Distribution Inc (006959555)