Label: TRIPROLIDINE HYDROCHLORIDE liquid

  • 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 January 19, 2022

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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 finalpart34111/09/2019
    Labeler - Rugby Laboratories (079246066)
    Establishment
    NameAddressID/FEIBusiness Operations
    MONARCH PCM, LLC080000294manufacture(0536-1257)
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