FDA Label for Flonase Nighttime Allergy Relief
View Indications, Usage & Precautions
Flonase Nighttime Allergy Relief Product Label
The following document was submitted to the FDA by the labeler of this product Haleon Us Holdings Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient (In Each Tablet)
Triprolidine HCl 2.5 mg
Purpose
Antihistamine
Uses
• 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
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
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
* Please review the disclaimer below.