FLONASE HEADACHE AND ALLERGY RELIEF- acetaminophen, chlorpheniramine maleate, phenylephrine hcl tablet 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active ingredient (in each caplet)

Acetaminophen 325 mg

Chlorpheniramine maleate 2 mg

Phenylephrine HCl 5 mg

Purposes

Pain reliever/Fever reducer

Antihistamine

Nasal decongestant

Uses

temporarily relieves these symptoms of hay fever or other upper respiratory allergies:
sinus congestion and pressure
runny nose and sneezing
minor aches and pains
nasal congestion
headache
temporarily relieves these additional symptoms of hay fever:
itching of the nose or throat
itchy, watery eyes
helps clear nasal passages
helps decongest sinus openings and passages

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage

may occur if you take

more than 4,000 mg of acetaminophen in 24 hours
with other drugs containing acetaminophen
3 or more alcoholic drinks every day while using this product

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms

may include:

blisters
rash
skin reddening

If a skin reaction occurs, stop use and seek medical help right away.

Do not use

with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have

difficulty in urination due to enlargement of the prostate gland
high blood pressure
a breathing problem such as emphysema or chronic bronchitis
heart disease
liver disease
thyroid disease
glaucoma
diabetes

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin
taking sedatives or tranquilizers

When using this product

do not exceed recommended dosage
excitability may occur, especially in children
alcohol, sedatives, and tranquilizers may increase drowsiness
avoid alcoholic beverages
use caution when driving a motor vehicle or operating machinery
drowsiness may occur

Stop use and ask a doctor if

nervousness, dizziness, or sleeplessness occur
pain or nasal congestion gets worse or lasts more than 7 days
new symptoms occur
fever gets worse or lasts more than 3 days
redness or swelling is present
 
These could be signs of a serious condition.

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. Prompt 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:
take 2 caplets every 4-6 hours
swallow whole – do not crush, chew, or dissolve
do not take more than 10 caplets in 24 hours
children under 12 years of age: ask a doctor

Other information

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

Inactive ingredients

benzyl alcohol, crospovidone, magnesium stearate, microcrystalline cellulose, modified corn starch, natural flavor, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, propylene glycol, purified water, silicon dioxide, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide

Questions or comments?

1-855-328-5259

Additional Information

KEEP CARTON FOR COMPLETE INFORMATION

Do not use if blister is broken or damaged.

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

NDC 0135-0578-03

FLONASE

HEADACHE &

ALLERGY RELIEF

NEW INGREDIENTS

Acetaminophen 325 mg Pain Reliever/Fever Reducer

Chlorpheniramine Maleate 2 mg Antihistamine

Phenylephrine HCI 5 mg Nasal Decongestant

FAST RELIEF FROM

Allergy Symptoms
Headache Pain
Nasal Congestion

96 CAPLETS

B-0630-778-46 ORG – Front Carton

 
B-0630-778-46 Flonase 96 Caplets
FLONASE  HEADACHE AND ALLERGY RELIEF
acetaminophen, chlorpheniramine maleate, phenylephrine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0578
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE2 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL (UNII: LKG8494WBH)  
CROSPOVIDONE (UNII: 2S7830E561)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) (UNII: 461P5CJN6T)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
STARCH, CORN (UNII: O8232NY3SJ)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorWHITEScoreno score
ShapeOVALSize17mm
FlavorImprint Code FRH
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0135-0578-011 in 1 CARTON03/10/2022
112 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:0135-0578-024 in 1 CARTON03/10/2022
248 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:0135-0578-038 in 1 CARTON03/10/2022
396 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34103/10/2022
Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)
Establishment
NameAddressID/FEIBusiness Operations
Zhejiang Kangle Pharmaceutical Co., Ltd421341487API MANUFACTURE(0135-0578)

Revised: 3/2022
Document Id: 282c103c-3888-4a35-a5b1-d492ed6892c1
Set id: 282c103c-3888-4a35-a5b1-d492ed6892c1
Version: 1
Effective Time: 20220331
 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC