Label: TRIPROLIDINE HYDROCHLORIDE syrup

  • NDC Code(s): 69367-253-30
  • Packager: Westminster Pharmaceuticals, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated May 1, 2020

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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 you have

    • glaucoma
    • a breathing problem such as emphysema or chronic bronchitis
    • 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 reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

  • Directions

    • do not exceed recommended dosage.
    • use only the enclosed dropper
    • do not use enclosed dropper for 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

    • This packaging is child-resistant.
    • Store at room temperature 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 1-844-221-7294.

  • PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton

    NDC 69367-253-30

    Triprolidine HCl
    Antihistamine
    Each dropperful (1 mL) contains:
    Triprolidine HCl 0.938 mg

    Sugar-Free • Dye Free • Alcohol Free

    Tamper evident by foil seal under cap.
    Do no use if foil seal is broken or missing.

    Bubble Gum Flavor
    1 fl oz (30 mL)

    Westminster
    Pharmaceuticals

    PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    TRIPROLIDINE HYDROCHLORIDE 
    triprolidine hydrochloride syrup
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69367-253
    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
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    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:69367-253-301 in 1 CARTON03/09/2020
    130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH DRUGM01203/09/2020
    Labeler - Westminster Pharmaceuticals, LLC (079516651)
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