Label: PENTREXCILINA SEVERE ALLERGY- diphenhydramine hydrochloride tablet, film coated

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

Drug Label Information

Updated May 17, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Diphenhydramine HCl 25 mg

    Purpose

    Active ingredient (in each tablet)Purpose
    Diphenhydramine HCl 25mgAntihistamine

  • 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.
  • 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

    • trouble urinating due to an enlarged prostate gland
    • a breathing problem such as emphysema or chronic bronchitis
    • glaucoma

    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
    • excitability may occur, especially in children
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • be careful when driving a motor vehicle or operating machinery

    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. Prompt medical attention is critical for adults as well as for children even if you not notice ant signs or symptoms.

  • Directions

    • take every 4 to 6 hours, or as directed by a doctor
    • do not take more than 6 doses in 24 hours
    adults and children 12 years and over1 or 2 caplets
    children 6 to under 12 years1 caplet
    children under 6 yearsdo not use
  • Other information

    • each tablet contains:calcium 23.52 mg
    • store at controlled room temperature 20-25°C (68-77°F).
    • read all product information before using
    • Tamper Evident: Do not use if imprinted safety seal under cap is broken or missing
  • Inactive ingredients

    Colloidal silicon dioxide, Croscarmellose Sodium, D&C red no. 27 aluminum lake, dicalcium phosphate, lecithin, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, titanium dioxide, talc

  • Questions or comments?

    call (619) 600-5632

    Monday through Friday 9AM - 5PM EST

  • PRINCIPAL DISPLAY PANEL

    NDC 69729-106-30

    Diphenhydramine HCL 25mg/Antihistamine

    Pentrexcilina®

    SEVERE ALLERGY

    Itchy, Watery Eyes - Picazón y lagrimeo en los ojos

    Sneezing - Estornudo

    Itchy Throat - Picazón en la garganta

    Runny Nose - Escurrimiento Nasal

    30 CAPLETS

    PSA2

    PSA22

  • INGREDIENTS AND APPEARANCE
    PENTREXCILINA SEVERE ALLERGY 
    diphenhydramine hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69729-106
    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
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeOVALSize10mm
    FlavorImprint Code D;25
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69729-106-301 in 1 CARTON05/17/2024
    130 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01205/17/2024
    Labeler - OPMX LLC (029918743)
    Establishment
    NameAddressID/FEIBusiness Operations
    Health Pharma USA LLC080804485manufacture(69729-106)
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