Label: ALLERGY- diphenhydramine hcl capsule

  • NDC Code(s): 36800-781-62, 36800-781-78
  • Packager: TOP CARE (Topco Associates LLC)
  • 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 October 14, 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
      • itchy, watery eyes
      • runny nose
      • 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 (59-86ºF)
    • 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 toll free 1-888-423-0139

  • Principal Display Panel

    MULTI-SYMPTOM

    ALLERGY Capsules

    Diphenhydramine HCl 25 mg Antihistamine

    For Allergy Relief

    •Sneezing  •Runny Nose  •Itchy, Watery Eyes  •Itchy Throat

    Capsules

    Each capsule individually banded for your protection

    COMPARE TO BENADRYL® active ingredient**

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

    DISTRIBUTED BY TOPCO ASSOICATES LLC

    ELK GROVE VILLAGE, IL 60007

    QUESTIONS? 1-888-423-0139

    topcare@topco.com   www.topcarebrand.com

    TAMPER EVIDENT: CAPSULE BANDED FOR YOUR PROTECTION. DO NOT USE IF BLISTER UNIT IS TORN OR BROKEN OR IF RED BAND AROUND CAPSULE IS BROKEN OR MISSING.

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

  • Product Label

    Diphenhydramine HCI 25 mg

    TopCare Multi-Symptom Allergy Capsules

  • INGREDIENTS AND APPEARANCE
    ALLERGY 
    diphenhydramine hcl capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-781
    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 BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    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
    ColorPINK, WHITEScoreno score
    ShapeCAPSULESize14mm
    FlavorImprint Code P25;CPC835
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:36800-781-6224 in 1 CARTON07/15/201612/30/2020
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:36800-781-781 in 1 BOX07/15/201612/30/2020
    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 FINALpart34107/15/201612/30/2020
    Labeler - TOP CARE (Topco Associates LLC) (006935977)