Label: HISTEX PD DROPS- triprolidine hydrochloride syrup

  • NDC Code(s): 28595-801-30
  • Packager: Allegis Pharmaceuticals, 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 December 20, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each 1 mL dropperful)

    Triprolidine HCl 0.938 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.

    • For dosing, use only the enclosed dropper and not with any other drug product.
    AGEDOSE
    Adults & Children 12 years of age or older:2.67 mL (2.5 milligrams) every 4 to 6 hours, not to exceed 10.67 mL (10 milligrams in 24 hours, or as directed by a doctor.
    Children 6 to under 12 years of age: 1.33 mL (1.25 milligrams) every 4 to 6 hours, not to exceed 5.33 mL (5 milligrams in 24 hours, or as directed by a doctor.
    Children under 6 years of age:Consult a doctor.
  • 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, methylparaben, monoammonium glycyrrhizinate, potassium citrate, potassium sorbate, propylene glycol, propylparaben, purified water, sucralose.

  • Questions? Comments?

    Call 1-866-633-9033.

  • PRINCIPAL DISPLAY PANEL - 30 mL Bottle Label

    NDC 28595-801-30

    HISTEX™ PD

    Drops

    Antihistamine

    Each dropperful (1 mL)

    contains:

    Triprolidine HCl 0.938 mg

    Sugar-Free • Dye Free

    Alcohol Free

    Bubble Gum Flavor

    1 fl oz (30 mL)

    Label

  • INGREDIENTS AND APPEARANCE
    HISTEX PD DROPS 
    triprolidine hydrochloride syrup
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:28595-801
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRIPROLIDINE HYDROCHLORIDE (UNII: YAN7R5L890) (TRIPROLIDINE - UNII:2L8T9S52QM) TRIPROLIDINE HYDROCHLORIDE0.938 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    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)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorBUBBLE GUMImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:28595-801-301 in 1 CARTON03/06/2014
    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 finalpart34103/06/2014
    Labeler - Allegis Pharmaceuticals, LLC (792272861)
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