Label: DIPHENHYDRAMINE HCL- diphenhydramine tablet, coated

  • NDC Code(s): 21091-695-01
  • Packager: Sergeants Pet Care Products LLC
  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated June 14, 2023

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  • Active ingredient (in each tablet)....... Purpose

    Diphenhydramine HCl 25 mg ................ Antihistamine

  • INDICATIONS & USAGE

    Uses Temporarily relieves: ■ sensitive itching skin ■ insect bites and stings ■ travel anxiety

  • PRECAUTIONS

    Caution
    Ask a veterinarian before use if your dog is taking sedatives, trouble urinating, is or may be pregnant, is lactating, has weakness, vomiting or not eating.

  • WARNINGS

    Warnings
    Keep out of reach of children and pets.
    In case of accidental overdose of dog, contact a veterinarian or veterinary emergency clinic.

  • DOSAGE & ADMINISTRATION

    Directions

    ■ Dogs weighing less than 14 pounds – ask a veterinarian

    ■ Dogs weighing 14 to 30 pounds - 1 tablet twice per day

    ■ Dogs weighing over 30 pounds - 2 tablets twice per day

  • OTHER SAFETY INFORMATION

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

    ■ each tablet contains: calcium 30 mg ■ consult a veterinarian if worse or no improvement of condition within 24 hours ■ store at 15-30˚C (59-86˚F) ■ protect from moisture

  • INACTIVE INGREDIENT

    corn starch, D&C red no 27 aluminum lake, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, stearic acid, talc, titanium dioxide.

  • QUESTIONS

    Questions? Comments? 1-800-224-7387

  • PetArmorAntihistamineDIPHENHYDRAMINE HCIFOR USE IN DOGS ONLY 100 Tablets 25 mg each    P000745 RAII - CartonP000674 AVIA - Label

    LabelCarton

  • INGREDIENTS AND APPEARANCE
    DIPHENHYDRAMINE HCL 
    diphenhydramine tablet, coated
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:21091-695
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
    Product Characteristics
    ColorpinkScoreno score
    ShapeOVALSize11mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21091-695-011 in 1 CARTON
    11 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other01/09/2023
    Labeler - Sergeants Pet Care Products LLC (876995171)
    Registrant - Sergeants Pet Care Products LLC (876995171)
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Safety

Report Adverse Events (Animal Drug), FDA Safety Recalls (Animal Drug)

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Clinical Trials, PubMed, Biochemical Data Summary

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