ALLERGY RELIEF- fluticasone propionate spray, metered 
Rugby Laboratories, Inc.

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Drug Facts

Active Ingredient (in each spray)

Fluticasone propionate (glucocorticold) 50 mcg

Purpose

Allergy symptom reliever

Uses

Temporarily relieves these symptoms of hay fever or other upper respiratory allergies:

Warnings

Only for use in the nose. Do not spray into your eyes or mouth.

Do not use

  • in children under 4 years of age
  • to treat asthma
  • if you have an injury or surgery to your nose that is not fully healed
  • if you have ever had an allergic reaction to this product or any of the ingredients

Ask a doctor before use if you

have or had glaucoma or cataracts

Ask a doctor or pharmacist before use if you are taking

  • medicine for HIV infection (such as ritonavir)
  • a steroid medicine for asthma, allergies or skin rash
  • ketoconazole pills (medicine for fungal infection)

When using this product

  • the growth rate of some children may be slower
  • stinging or sneezing may occur for a few seconds right after use
  • do not share this bottle with anyone else as this may spread germs
  • remember to tell your doctor about all the medicines you take, including this one

Stop use and ask a doctor if

  • you have, or come into contact with someone who has, chicken pox, measles or tuberculosis
  • your symptoms do not get better within 7 days of starting use or you get new symptoms such as severe facial pain or thick nasal discharge. You may have something more than allergies, such as an infection.
  • you get a constant whistling sound from your nose. This may be a sign of damage inside your nose.
  • you get an allergic reaction to this product. Seek medical help right away.
  • you get new changes to your vision that develop after starting this product
  • you have severe or frequent nosebleeds

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 (1-800-222-1222) right away.

Directions

ADULTS AND CHILDREN 12 YEARS OF AGE AND OLDER

CHILDREN 4 TO 11 YEARS OF AGE

CHILDREN UNDER 4 YEARS OF AGE

Other information

Inactive ingredients

benzalkonium chloride, carboxymethylcellulose sodium, dextrose, microcrystalline cellulose, phenylethyl alcohol, polysorbate 80, purified water

Questions or comments?

call 1-800-616-2471

Principal display panel

Compare to the active ingredient in Flonase®*

Full Prescription Strength

Fluticasone Propionate

Nasal Spray

(Glucocorticoid)< 50 mcg per spray

Allergy Symptom Reliever Nasal Spray

24 Hour

Relief of:

Non-drowsy

24-Hour Relief

Metered Sprays

FL OZ (mL)

*This product is not distributed by GlaxoSmithKline, owner of the registered trademark Flonase®.

Distributed by:

RUGBY LABORATORIES

Indianapolis, IN 46268

www.majorpharmaceuticals.com

Package label

Fluticasone Propionate (glucocorticoid) 50 mcg

RUGBY Allergy SymptomReliever Nasal Spray

ALLERGY RELIEF 
fluticasone propionate spray, metered
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1373
Route of AdministrationNASAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FLUTICASONE PROPIONATE (UNII: O2GMZ0LF5W) (FLUTICASONE - UNII:CUT2W21N7U) FLUTICASONE PROPIONATE50 ug
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
WATER (UNII: 059QF0KO0R)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0536-1373-371 in 1 PACKAGE09/15/202212/31/2024
160 in 1 BOTTLE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
2NDC:0536-1373-381 in 1 PACKAGE09/15/202212/31/2024
2120 in 1 BOTTLE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20802409/15/202212/31/2024
Labeler - Rugby Laboratories, Inc. (079246066)

Revised: 10/2023
Document Id: 66ede09a-41a4-4e14-a007-31de53efec8f
Set id: eaa08040-99f5-4ccc-82c5-469639f10601
Version: 4
Effective Time: 20231017
 
Rugby Laboratories, Inc.