Label: TYLENOL SINUS CONGESTION AND PAIN- acetaminophen and phenylephrine hydrochloride tablet, coated

  • NDC Code(s): 50580-229-02, 50580-229-24, 50580-229-48, 50580-229-72
  • Packager: McNeil Consumer Healthcare Div McNeil-PPC, Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 11/10

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

  • SPL UNCLASSIFIED SECTION

    Important: Read all product information before using. Keep this box for important information.

    Drug Facts

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  • ACTIVE INGREDIENT

    Active ingredients (in each gelcap) Purpose
    Acetaminophen 325 mg Pain reliever
    Phenylephrine HCl 5 mg Nasal decongestant
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  • Uses

    • for the temporary relief of:
      • headache
      • sinus congestion and pressure
      • nasal congestion
      • minor aches and pains
    • helps decongest sinus openings and passages
    • promotes sinus drainage
    • helps clear nasal passages
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  • Warnings

    Liver warning

    This product contains acetaminophen. Severe liver damage may occur if you take

    • more than 12 gelcaps in 24 hours, which is the maximum daily amount
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks every day while using this product

    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

    • liver disease
    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • trouble urinating due to an enlarged prostate gland

    Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

    When using this product do not exceed recommended dosage

    Stop use and ask a doctor if

    • nervousness, dizziness, or sleeplessness occur
    • pain or nasal congestion gets worse or lasts more than 7 days
    • fever gets worse or lasts more than 3 days
    • redness or swelling is present
    • new symptoms occur

    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.

    Overdose warning

    Taking more than the recommended dose (overdose) may cause liver damage.

    In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

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  • Directions

    adults and children 12 years and over
    • take 2 gelcaps every 4 hours
    • do not take more than 12 gelcaps in 24 hours
    children under 12 years do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage
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  • Other information

    • store between 20-25°C (68-77°F). Avoid high humidity.
    • do not use if carton is opened or if blister unit is broken
    • see side panel for lot number and expiration date
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  • Inactive ingredients

    benzyl alcohol, black iron oxide, butylparaben, carboxymethylcellulose sodium, colloidal silicon dioxide, corn starch, D&C yellow #10, edetate calcium disodium, FD&C blue #1, FD&C blue #2, FD&C red #40, gelatin, hypromellose, methylparaben, microcrystalline cellulose, polyethylene glycol, polysorbate 80, powdered cellulose, pregelatinized starch, propylene glycol, propylparaben, red iron oxide, sodium lauryl sulfate, sodium propionate, sodium starch glycolate, stearic acid, titanium dioxide, yellow iron oxide

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  • Questions or comments?

    call 1-877-895-3665

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  • PRINCIPAL DISPLAY PANEL

    NDC 50580-229-24

    See New Warnings Information

    TYLENOL®

    SINUS
    CONGESTION & PAIN

    Alleviates Sinus Headache & Pain
    Acetaminophen

    Relieves Sinus Pressure
    Clears Nasal Congestion
    Phenylephrine HCl

    24 RR GELCAPS

    Rapid Release
    GELS

    DAYTIME
    Non-Drowsy

    Principal Display Panel
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  • INGREDIENTS AND APPEARANCE
    TYLENOL SINUS   CONGESTION AND PAIN
    acetaminophen and phenylephrine hydrochloride tablet, coated
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:50580-229
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Acetaminophen (Acetaminophen) Acetaminophen 325 mg
    Phenylephrine hydrochloride (Phenylephrine) Phenylephrine hydrochloride 5 mg
    Inactive Ingredients
    Ingredient Name Strength
    benzyl alcohol  
    ferrosoferric oxide  
    butylparaben  
    carboxymethylcellulose sodium  
    silicon dioxide  
    starch, corn  
    D&C yellow NO. 10  
    edetate calcium disodium  
    FD&C Blue NO. 1  
    FD&C Blue NO. 2  
    FD&C red NO. 40  
    gelatin  
    hypromelloses  
    methylparaben  
    cellulose, microcrystalline  
    polyethylene glycol  
    polysorbate 80  
    powdered cellulose  
    propylene glycol  
    propylparaben  
    ferric oxide red  
    sodium lauryl sulfate  
    sodium propionate  
    sodium starch glycolate type a potato  
    stearic acid  
    titanium dioxide  
    ferric oxide yellow  
    Product Characteristics
    Color RED, GREEN (Red and green with gray subcoat band) Score no score
    Shape OVAL Size 19mm
    Flavor Imprint Code TY;S;CP
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50580-229-02 2500 in 1 TRAY
    1 2 in 1 POUCH
    2 NDC:50580-229-24 2 in 1 CARTON
    2 12 in 1 BLISTER PACK
    3 NDC:50580-229-48 4 in 1 CARTON
    3 12 in 1 BLISTER PACK
    4 NDC:50580-229-72 1 in 1 CARTON
    4 72 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part341 07/01/2007
    Labeler - McNeil Consumer Healthcare Div McNeil-PPC, Inc (878046358)
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