Label: ALLERGY- diphenhydramine hcl capsule

  • NDC Code(s): 49781-147-24, 49781-147-51
  • Packager: Cardinal Health (Leader) 49781
  • 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 6, 2019

If you are a consumer or patient please visit this version.

  • 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
      • sneezing 
      • runny nose
      • itchy, watery eyes
      • itching of the nose or throat
  • 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

    • 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.

  • 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 overtake 1 to 2 capsules 
    children 6 to under 12 years of age take 1 capsule
    children under 6 years of age do not use

  • Other information

    • store between 15-30ºC (59° to 86°F) 
    • Protect from light
  • Inactive ingredients

    butylparaben*, D&C red #28,edible black ink, FD&C blue #1, FD&C red #40, FD&C yellow #6*, gelatin, lactose*, lactose monohydrate*, magnesium stearate*, methylparaben*, polysorbate 80*, propylparaben*, purified water*, sodium lauryl sulphate*, starch

    *contains one or more of these ingredients

  • Questions or comments?

    Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

  • Principal Display Panel

    Compare to Benadryl® Allergy active ingredient**

    Allergy Capsules

    Diphenhydramine HCl 25 mg

    Antihistamine

    For allergy relief

    Runny nose

    Sneezing

    Itchy throat

    Itchy, watery eyes

    Capsules

    Each capsule individually banded for your protection

    **This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Benadryl®.

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

    TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING OR IF RED BAND AROUND CAPSULE IS BROKEN OR MISSING. 

    DISTRIBUTED BY: CARDINAL HEALTH

    DUBLIN, OHIO 43047

    www.myleader.com

    1-800-200-6313

  • Product Label

    Diphenhydramine HCl 25 mg

    Leader Allergy Capsules

  • INGREDIENTS AND APPEARANCE
    ALLERGY 
    diphenhydramine hcl capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49781-147
    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
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    D&C RED NO. 28 (UNII: 767IP0Y5NH)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GELATIN (UNII: 2G86QN327L)  
    LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorWHITE, PINKScoreno score
    ShapeCAPSULESize14mm
    FlavorImprint Code CPC835;DH;25
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49781-147-241 in 1 BOX01/31/201612/31/2021
    124 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:49781-147-511 in 1 BOX01/31/201612/31/2021
    2100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34101/31/201612/31/2021
    Labeler - Cardinal Health (Leader) 49781 (097537435)