FLONASE by Haleon US Holdings LLC Drug Facts

FLONASE by

Drug Labeling and Warnings

FLONASE by is a Otc medication manufactured, distributed, or labeled by Haleon US Holdings LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

FLONASE NIGHTTIME ALLERGY RELIEF- triprolidine hcl tablet 
Haleon US Holdings LLC

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Drug Facts

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

36 TABLETS

080320 – Front Carton

FLONASE  NIGHTTIME ALLERGY RELIEF
triprolidine hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0135-1329
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TRIPROLIDINE HYDROCHLORIDE (UNII: YAN7R5L890) (TRIPROLIDINE - UNII:2L8T9S52QM)	TRIPROLIDINE HYDROCHLORIDE	2.5 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	WHITE	Score	no score
Shape	ROUND	Size	7mm
Flavor		Imprint Code	FN
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0135-1329-01	1 in 1 CARTON	12/15/2022	02/28/2026
1		36 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	12/15/2022	02/28/2026

Labeler - Haleon US Holdings LLC (079944263)

Revised: 10/2024

Document Id: 669165f1-6d53-4020-8f01-fbd9cb09c99b

34390-5

Set id: 070fb5a4-1848-41e8-90bf-57e682de1762

Version: 4

Effective Time: 20241002