Label: FLONASE HEADACHE AND ALLERGY RELIEF- acetaminophen, chlorpheniramine maleate, phenylephrine hcl tablet

  • NDC Code(s): 0135-0578-01, 0135-0578-02, 0135-0578-03
  • Packager: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated March 31, 2022

If you are a consumer or patient please visit this version.

  • 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
  • INGREDIENTS AND APPEARANCE
    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)