Label: TRIPROLIDINE HYDROCHLORIDE liquid

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

Drug Label Information

Updated January 10, 2024

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  • SPL UNCLASSIFIED SECTION

    Rugby Laboratories Triprolidine HCl 0.938mg/1mL Bubblegum Liquid

    NDC: 0536-1257-75

    Drug Facts

  • Active ingredient

  • Purpose

    (in each 1 mL dropperful)

    Triprolidine HCI 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

    ■ may cause drowsiness  

    ■ excitability may occur, especially in children

    ■ 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 with enclosed dropper

    ■ do not use enclosed dropper for any other drug product

    AgeDose
    adult and children 12 year 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, methylparaben, monoammonium glycyrrhizinate, potassium citrate, potassium sorbate, propylene glycol, propylparaben, purified water, sucralose

  • Questions or comments?

    Call 1-800-645-2158.

  • PRINCIPAL DISPLAY PANEL

    NDC 0536-1257-75

    Rugby
    Triprolidine HCl
    Antihistamine
    0.938mg/1mL
    Bubblegum Liquid

    PRINCIPAL DISPLAY PANEL NDC 0536-1257-75 Rugby Triprolidine HCl Antihistamine 0.938mg/1mL Bubblegum Liquid

  • INGREDIENTS AND APPEARANCE
    TRIPROLIDINE HYDROCHLORIDE 
    triprolidine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1257
    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)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)  
    POTASSIUM CITRATE (UNII: EE90ONI6FF)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorBUBBLE GUMImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0536-1257-7530 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product11/09/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01211/09/201910/31/2024
    Labeler - Rugby Laboratories (079246066)
    Establishment
    NameAddressID/FEIBusiness Operations
    MONARCH PCM, LLC080000294manufacture(0536-1257)
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