Label: HISTEX PDX DROPS- triprolidine hydrochloride syrup

  • NDC Code(s): 28595-808-30
  • Packager: Allegis Pharmaceuticals, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 8, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each 1 mL dropperful)

    Triprolidine HCl 1.25 mg

  • Purpose

    Antihistamine

  • Uses

    temporarily relieves these symptoms due to hay fever (allergic rhinitis) or other upper respiratory allergies:

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

    Do not exceed recommended dosage.

    Ask a doctor before use if the child has

    • a breathing problem such as emphysema or chronic bronchitis
    • glaucoma

    Ask a doctor before use if the child is taking sedatives or tranquilizers

    When using this product

    • excitability may occur, especially in children
    • may cause drowsiness
    • sedatives and tranquilizers may increase the drowsiness effect

    Stop use and ask a doctor if

    • new symptoms occur

    Keep out of the reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away.

  • Directions

    Do not exceed recommended dosage.

    • use only the enclosed dropper.
    • do not use enclosed dropper for any other drug products.
    AGEDOSE
    Adutls & Children 12 years of age or older:2 mL (2.5 mg) every 4 to 6 hours, not to exceed 8 mL (10 mg) in 24 hours or as directed by a doctor.
    Children 6 to under12 years of age:1 mL (1.25 mg) every 4 to 6 hours, not to exceed 4 mL (5 mg) in 24 hours or as directed by a doctor.
    Children under 6 years of age: Consult a docotor.
  • Other Information

    Store at 15°-30° C (59°-86° F).

    Tamper evident by foil seal under cap. Do not use if foil seal is missing or broken.

  • Inactive ingredients

    bubble gum flavor, citric acid, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose.

  • Questions? Comments?

    Call 1-866-633-9033.

  • PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton

    NDC 28595-808-30

    HISTEX™ PDX

    Drops

    Antihistamine

    Each dropperful (1 mL)

    contains:

    Triprolidine HCl

    1.25 mg

    Sugar-Free • Dye Free

    Alcohol Free

    Bubble Gum Flavor

    1 fl oz (30 mL) Bottle

    Carton

  • INGREDIENTS AND APPEARANCE
    HISTEX PDX DROPS 
    triprolidine hydrochloride syrup
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:28595-808
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRIPROLIDINE HYDROCHLORIDE (UNII: YAN7R5L890) (TRIPROLIDINE - UNII:2L8T9S52QM) TRIPROLIDINE HYDROCHLORIDE1.25 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorBUBBLE GUMImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:28595-808-301 in 1 CARTON01/16/2023
    130 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01201/16/2023
    Labeler - Allegis Pharmaceuticals, LLC (792272861)
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