Label: HISTEX- triprolidine hydrochloride syrup

  • NDC Code(s): 28595-802-08
  • 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 19, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients (in each 5 mL teaspoonful)

    Triprolidine HCl 2.5 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 you have

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

    Ask a doctor before use if you are taking sedatives or tranquilizers

    When using this product

    • excitability may occur, especially in children
    • may cause drowsiness
    • alcohol, sedatives and tranquilizers may increase the drowsiness effect
    • avoid alcoholic beverages
    • use caution when driving a motor vehicle or operating machinery

    Stop use and ask a doctor if

    • new symptoms occur

    If pregnant or breast-feeding, ask a health professional before use.

    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.

    AGEDOSE
    Adults and Childen 12 years of age and older:1 teaspoonful (5 mL) every 4 to 6 hours, not to exceed 4 teaspoonfuls (20 mL) in 24 hours, or as directed by a doctor
    Childen 6 to under 12 years of age½ teaspoonful (2.5 mL) every 4 to 6 hours, not to exceed 2 teaspoonfuls (10 mL) in 24 hours, or as directed by a doctor.
    Children under 6 years of ageConsult 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.

    Dispense in a tight, light-resistant container with a child-resistant cap.

  • Inactive ingredients

    Citric Acid, Glycerin, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol, Bubble Gum Flavor.

  • Questions? Comments?

    Call 1-866-633-9033.

  • PRINCIPAL DISPLAY PANEL - 237 mL Bottle Label

    NDC 28595-802-08

    Antihistamine

    HISTEX™

    Syrup

    Each teaspoonful (5 mL)

    contains:

    Triprolidine HCl 2.5 mg

    Sugar-Free • Dye Free

    Alcohol Free

    Bubble Gum Flavor

    8 fl oz (237 mL)

    Label

  • INGREDIENTS AND APPEARANCE
    HISTEX 
    triprolidine hydrochloride syrup
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:28595-802
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRIPROLIDINE HYDROCHLORIDE (UNII: YAN7R5L890) (TRIPROLIDINE - UNII:2L8T9S52QM) TRIPROLIDINE HYDROCHLORIDE2.5 mg  in 5 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)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorBUBBLE GUMImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:28595-802-08237 mL in 1 BOTTLE; Type 0: Not a Combination Product03/04/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34103/04/2014
    Labeler - Allegis Pharmaceuticals, LLC (792272861)
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