Label: DIPHENHIST- diphenhydramine hcl capsule

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 11, 2024

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  • Drug Facts

    Active ingredient (in each banded capsule)

    Diphenhydramine HCl 25 mg

  • PURPOSE

    Purpose

    Antihistamine

  • Uses

    temporarily relieves these symptoms of 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 operating machinery or driving a motor vehicle
    • excitability may occur, especially in children

    If pregnant of 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

    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 hours

    adults and children 12 years of age and over

    1 to 2 capsules

    children 6 to under 12 years of age

    1 capsule

    children under 6 years of age

    do not use this product in children under 6 years of age

  • Other information

    • store at controlled room temperature 15°-30°C (59°-86°F) in a dry place
    • protect from moisture
    • contains lactose
  • Inactive ingredients

    D&C red #28, FD&C blue #1, FD&C red #40, gelatin, lactose and starch.

  • Questions or comments?

    1-800-645-2158

  • SPL UNCLASSIFIED SECTION

    DO NOT USE IF EITHER CAPSULE BAND OR IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

    Distributed by: Rugby Laboratories

    17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152

    www.rugbylaboratories.com

  • PRINCIPAL DISPLAY PANEL

    Rugby

    NDC 0536-1010-01

    Diphenhist

    Diphenhydramine HCl USP, 25 mg

    Antihistamine

    For the temporary relief of the Symptoms of Upper Respiratory Allergies & Hay Fever

    100 Banded Capsules

    0835-rugby label

  • INGREDIENTS AND APPEARANCE
    DIPHENHIST 
    diphenhydramine hcl capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1010
    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
    STARCH, CORN (UNII: O8232NY3SJ)  
    D&C RED NO. 28 (UNII: 767IP0Y5NH)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GELATIN (UNII: 2G86QN327L)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    Product Characteristics
    Colorpink (Half pink and half clear with white powder inside) Scoreno score
    ShapeCAPSULESize14mm
    FlavorImprint Code CPC;835
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0536-1010-01100 in 1 BOTTLE; Type 0: Not a Combination Product03/17/201404/30/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01203/17/201404/30/2025
    Labeler - Rugby Laboratories (079246066)
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