Label: ALLERGY- diphenhydramine hydrochloride capsule 

  • Label RSS
  • NDC Code(s): 30142-462-62, 30142-462-67, 30142-462-78
  • Packager: Kroger Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 03/14

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  • Active ingredient (in each capsule)

    Diphenhydramine HCl 25 mg

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  • Purpose

    Antihistamine

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  • 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
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  • 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)

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  • Directions

    take every 4 to 6 hours
    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 use this product in children under 6 years of age

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  • Inactive ingredients

    anhydrous lactose, benzyl alcohol, butylparaben, D&C red #28, edetate calcium disodium, edible ink, FD&C blue #1, FD&C red #40, gelatin, magnesium stearate, methylparaben, polysorbate 80, propylparaben, sodium lauryl sulfate, sodium propionate

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  • Questions or comments?

    1-800-632-6900

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  • Principal Display Panel

    COMPARE TO the active ingredient of BENADRYL® ALLERGY

    See top panel

    Allergy Capsules

    Diphenhydramine HCl 25 mg EACH

    Antihistamine

    Relieves:

    Sneezing

    Itchy, Watery Eyes

    Itchy Throat

    Runny Nose

    100 CAPSULES

    25 mg EACH

    actual size

    EASY TO SWALLOW

    Allergy Capsules Image 1
    Allergy Capsules Image 2
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  • INGREDIENTS AND APPEARANCE
    ALLERGY 
    diphenhydramine hydrochloride capsule
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:30142-462
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg
    Inactive Ingredients
    Ingredient Name Strength
    ANHYDROUS LACTOSE  
    BENZYL ALCOHOL  
    BUTYLPARABEN  
    D&C RED NO. 28  
    EDETATE CALCIUM DISODIUM  
    FD&C BLUE NO. 1  
    FD&C RED NO. 40  
    GELATIN  
    MAGNESIUM STEARATE  
    METHYLPARABEN  
    POLYSORBATE 80  
    PROPYLPARABEN  
    SODIUM LAURYL SULFATE  
    SODIUM PROPIONATE  
    Product Characteristics
    Color PINK (clear) , WHITE (clear) , RED (band) Score no score
    Shape CAPSULE Size 14mm
    Flavor Imprint Code L462
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:30142-462-62 12 in 1 CARTON
    1 2 in 1 BLISTER PACK
    2 NDC:30142-462-67 24 in 1 CARTON
    2 2 in 1 BLISTER PACK
    3 NDC:30142-462-78 1 in 1 CARTON
    3 100 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 08/15/1990
    Labeler - Kroger Company (006999528)
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