FDA.reportPublic FDA data

FLONASE

Manufacturer
Haleon US Holdings LLC
Effective date
2024-10-02
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 20:53:21

Label at a glance#

ProductFLONASE Nighttime Allergy Relief
Active ingredientTRIPROLIDINE HYDROCHLORIDE
Label structure9 sections

Indications and 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

Dosage and administration

• 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

Storage and handling

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

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Triprolidine HCl 2.5 mg

Uses

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

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.

OTC - ASK DOCTOR SECTION

When using this product

OTC - WHEN USING SECTION

  • 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.

OTC - STOP USE SECTION

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

  • 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

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

1-844-356-6273

Additional Information

SPL UNCLASSIFIED SECTION

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

PACKAGE LABEL.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
080320 Flonase Nighttime Allergy Relief 36 Tablets

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0135-1329FLONASE NIGHTTIME ALLERGY RELIEF (TRIPROLIDINE HCL) TABLET [HALEON US HOLDINGS LLC]4Legacy NDC20241004_070fb5a4-1848-41e8-90bf-57e682de1762.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0135-13290135-1329-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
TRIPROLIDINE HYDROCHLORIDEYAN7R5L890ACTIB
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
STARCH, CORNO8232NY3SJIACT
TITANIUM DIOXIDE15FIX9V2JPIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
669165f1-6d53-4020-8f01-fbd9cb09c99b070fb5a4-1848-41e8-90bf-57e682de17622024-10-02WarningsExact identifier
spl id: 669165f1-6d53-4020-8f01-fbd9cb09c99b
spl set id: 070fb5a4-1848-41e8-90bf-57e682de1762

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.