Label: FLONASE NIGHTTIME ALLERGY RELIEF- triprolidine hcl tablet

  • NDC Code(s): 0135-1329-01
  • Packager: Haleon US Holdings LLC
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated March 22, 2024

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  • Active ingredient (in each tablet)

    Triprolidine HCl 2.5 mg

  • Purpose

  • Uses

    • temporarily relieves these symptoms due to hay fever (allergic rhinitis) or other upper respiratory allergies:
    1. runny nose
    2. sneezing
    3. itching of the nose or throat
    4. 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

    36TABLETS

    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 DrugM01212/15/2022
    Labeler - Haleon US Holdings LLC (079944263)
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