Label: FLONASE NIGHTTIME ALLERGY RELIEF- triprolidine hcl tablet

  • NDC Code(s): 0135-1329-01
  • Packager: GlaxoSmithKline Consumer Healthcare Holdings (US) 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 November 29, 2022

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  • Active ingredient (in each tablet)

    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

    Ask a doctor before use if you have

    •
    glaucoma
    •
    difficulty in urination due to enlargement of the prostate gland
    •
    a breathing problem such as emphysema or chronic bronchitis

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

    When using this product

    •
    do not exceed recommended dosage
    •
    excitability may occur, especially in children
    •
    drowsiness may occur
    •
    alcohol, sedatives, and tranquilizers may increase drowsiness
    •
    avoid alcoholic beverages while taking this product
    •
    be careful 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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • Directions

    •
    do not use more than directed
    •
    adults and children 12 years of age and over: 1 tablet (2.5 mg) every 4 to 6 hours; not to exceed 4 tablets (10 mg) in 24 hours or as directed by a doctor
    •
    children under 12 years of age: do not use
  • Other information

    •
    store at controlled room temperature 20-25°C (68-77°F)
  • Inactive ingredients

    hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, titanium dioxide

  • Questions or comments?

    1-844-356-6273

  • Additional Information

    KEEP CARTON FOR COMPLETE INFORMATION

    Do not use if blister is broken or damaged.

    *Dosage is 1 tablet every 4 to 6 hours

    Distributed by:

    GSK Consumer Healthcare

    Warren, NJ 07059

    Trademarks are owned by or licensed to the GSK group of companies.

    ©2022 GSK group of companies or its licensor.

  • Principal Display Panel

    FLONASE

    NIGHTTIME ALLERGY RELIEF

    NEW INGREDIENT

    Triprolidine HCl 2.5 mg - Antihistamine

    UP TO
    6 HOURS* RELIEF FROM

    •
    Sneezing
    •
    Runny nose
    •
    Itchy throat
    •
    Itchy, watery eyes

    36 TABLETS

    080320 – Front Carton

     
    080320 Flonase Nighttime Allergy Relief 36 Tablets
  • INGREDIENTS AND APPEARANCE
    FLONASE  NIGHTTIME ALLERGY RELIEF
    triprolidine hcl tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-1329
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRIPROLIDINE HYDROCHLORIDE (UNII: YAN7R5L890) (TRIPROLIDINE - UNII:2L8T9S52QM) TRIPROLIDINE HYDROCHLORIDE2.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeROUNDSize7mm
    FlavorImprint Code FN
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0135-1329-011 in 1 CARTON12/15/2022
    136 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34112/15/2022
    Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)
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