Label: ADVIL SINUS CONGESTION AND PAIN- ibuprofen, phenylephrine hydrochloride tablet, coated

  • NDC Code(s): 0573-0199-01, 0573-0199-03, 0573-0199-11, 0573-0199-21, view more
    0573-0199-22
  • Packager: Wyeth Consumer Healthcare LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated October 11, 2019

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each tablet)Purposes
    *
    nonsteroidal anti-inflammatory drug
    Ibuprofen 200 mg (NSAID)*Pain reliever/fever reducer
    Phenylephrine HCl 10 mgNasal decongestant
  • INDICATIONS & USAGE

    Uses

    • temporarily relieves these symptoms associated with the common cold or flu:
      • headache
      • fever
      • sinus pressure
      • nasal congestion
      • minor body aches and pains
    • reduces swelling of the nasal passages
    • temporarily restores freer breathing through the nose
  • WARNINGS

    Warnings

    Allergy alert

    Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

    • hives
    • facial swelling
    • asthma (wheezing)
    • shock
    • skin reddening
    • rash
    • blisters

    If an allergic reaction occurs, stop use and seek medical help right away.

    Stomach bleeding warning

    This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:

    • are age 60 or older
    • have had stomach ulcers or bleeding problems
    • take a blood thinning (anticoagulant) or steroid drug
    • take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
    • have 3 or more alcoholic drinks every day while using this product
    • take more or for a longer time than directed

    Heart attack and stroke warning

    NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.

    Do not use

    • in children under 12 years of age because this product contains too much medication for children under this age
    • if you have ever had an allergic reaction to any other pain reliever/fever reducer
    • right before or after heart surgery
    • 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

    Ask a doctor before use if

    • stomach bleeding warning applies to you
    • you have problems or serious side effects from taking pain relievers or fever reducers
    • you have a history of stomach problems, such as heartburn
    • you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, thyroid disease, diabetes, have trouble urinating due to an enlarged prostate gland, or had a stroke
    • you are taking a diuretic

    Ask a doctor or pharmacist before use if you are

    • under a doctor's care for any serious condition
    • taking any other product that contains phenylephrine or any other nasal decongestant
    • taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
    • taking any other drug

    When using this product

    • take with food or milk if stomach upset occurs

    Stop use and ask a doctor if

    • you experience any of the following signs of stomach bleeding:
      • feel faint
      • vomit blood
      • have bloody or black stools
      • have stomach pain that does not get better
    • you have symptoms of heart problems or stroke:
      • chest pain
      • trouble breathing
      • weakness in one part or side of body
      • slurred speech
      • leg swelling
    • pain gets worse or lasts more than 7 days
    • fever gets worse or lasts more than 3 days
    • nasal congestion lasts for more than 7 days
    • symptoms continue or get worse
    • redness or swelling is present in the painful area
    • you get nervous, dizzy, or sleepless
    • any new symptoms appear

    If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    • do not take more than directed
    • adults and children 12 years of age and over:
      • take 1 tablet every 4 hours while symptoms persist.
      • do not use more than 6 tablets in any 24-hour period unless directed by a doctor
    • children under 12 years of age: do not use because this product contains too much medication for children under this age
  • STORAGE AND HANDLING

    Other information

    • store at 20-25°C (68-77°F). Avoid excessive heat above 40°C (104°F).
    • read all warnings and directions before use. Keep carton.
  • INACTIVE INGREDIENT

    Inactive ingredients

    acesulfame potassium, artificial flavor, carnauba wax, colloidal silicon dioxide, corn starch, croscarmellose sodium, glycerin, hypromellose, lactic acid, lecithin, maltodextrin, medium-chain triglycerides, microcrystalline cellulose, pharmaceutical ink, polydextrose, polyvinyl alcohol, pregelatinized starch, propyl gallate, sodium lauryl sulfate, stearic acid, sucralose, synthetic iron oxide, talc, titanium dioxide, triacetin, xanthan gum

  • QUESTIONS

    Questions or comments?

    Call weekdays from 9 AM to 5 PM EST toll free at 1-800-88-ADVIL

    For most recent product information, visit www.advil.com

  • PRINCIPAL DISPLAY PANEL - 1 Tablet Pouch

    Advil®
    SINUS CONGESTION & PAIN

    Ibuprofen, 200 mg/Phenylephrine HCl, 10 mg
    Pain Reliever/Fever Reducer (NSAID)*/Nasal Decongestant

    *nonsteroidal anti-inflammatory drug

    1 Tablet Non-Drowsy

    PRINCIPAL DISPLAY PANEL - 1 Tablet Pouch
  • PRINCIPAL DISPLAY PANEL - 50 Pouch Tray

    NON-DROWSY

    Advil®

    SINUS
    CONGESTION & PAIN

    Ibuprofen 200 mg Pain Reliever/Fever Reducer (NSAID)
    Phenylephrine HCI 10 mg Nasal Decongestant

    Nasal Congestion
    Headache
    Sinus Pressure
    Fever
    Nasal Swelling
    Body Aches

    ONE
    TABLET
    DOSE!

    50
    Packets of 1
    Coated Tablet

    PRINCIPAL DISPLAY PANEL - 50 Pouch Tray
  • PRINCIPAL DISPLAY PANEL - 10 Tablet Blister Pack

    Advil®
    Sinus Congestion & Pain

    Ibuprofen 200 mg /
    Phenylephrine HCl 10 mg
    See warnings before use.
    Pfizer, Madison, NJ 07940 USA

    PEEL & PUSH

    AREA FOR EXP. & LOT

    PRINCIPAL DISPLAY PANEL - 10 Tablet Blister Pack
  • PRINCIPAL DISPLAY PANEL - 20 Tablet Blister Pack Carton

    NON-DROWSY

    Advil®

    SINUS
    CONGESTION & PAIN

    Ibuprofen 200 mg Pain Reliever/Fever Reducer (NSAID)
    Phenylephrine HCl 10 mg Nasal Decongestant

    ONE
    TABLET
    DOSE!

    Nasal Congestion
    Headache
    Sinus Pressure
    Fever
    Nasal Swelling
    Body Aches

    20
    Coated
    Tablets

    PRINCIPAL DISPLAY PANEL - 20 Tablet Blister Pack Carton
  • Principal Display Panel - 30 Tablet Blister Pack Carton

    NON-DROWSY

    Advil®

    50%
    MORE
    10 FREE
    Tablets

    SINUS
    CONGESTION & PAIN

    Ibuprofen 200 mg Pain Reliever/Fever Reducer (NSAID)
    Phenylephrine HCl 10 mg Nasal Decongestant

    Nasal Congestion
    Headache
    Sinus Pressure
    Fever
    Nasal Swelling
    Body Aches

    ONE
    TABLET
    DOSE!

    30
    Coated
    Tablets

    Principal Display Panel - 30 Tablet Blister Pack Carton
  • INGREDIENTS AND APPEARANCE
    ADVIL SINUS CONGESTION AND PAIN 
    ibuprofen, phenylephrine hydrochloride tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0573-0199
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)  
    EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYDEXTROSE (UNII: VH2XOU12IE)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    PROPYL GALLATE (UNII: 8D4SNN7V92)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorBROWN (tan) Scoreno score
    ShapeOVALSize15mm
    FlavorImprint Code 1200;P10
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0573-0199-1110 in 1 CARTON07/01/2015
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:0573-0199-2120 in 1 CARTON07/01/2015
    21 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:0573-0199-0150 in 1 TRAY07/01/2015
    31 in 1 POUCH; Type 0: Not a Combination Product
    4NDC:0573-0199-2230 in 1 CARTON11/02/2015
    41 in 1 BLISTER PACK; Type 0: Not a Combination Product
    5NDC:0573-0199-033000 in 1 CARTON07/01/2015
    51 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02256507/01/2015
    Labeler - Wyeth Consumer Healthcare LLC (828831730)
    Registrant - Pfizer Inc (113480771)
    Establishment
    NameAddressID/FEIBusiness Operations
    Wyeth Pharmaceuticals Company829390975ANALYSIS(0573-0199) , LABEL(0573-0199) , MANUFACTURE(0573-0199) , PACK(0573-0199)
    Establishment
    NameAddressID/FEIBusiness Operations
    Wyeth Consumer Healthcare LLC828831730ANALYSIS(0573-0199) , MANUFACTURE(0573-0199)