Label: SINUS CONGESTION AND PAIN- acetaminophen and phenylephrine hydrochloride capsule

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 11/12

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

  • Active ingredients (in each gelcap)

    Acetaminophen 325 mg
    Phenylephrine HCl 5 mg

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  • Purpose

    Pain reliever
    Nasal decongestant

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  • Uses

    • for the temporary relief of:
      • headache
      • sinus congestion and pressure
      • minor aches and pains
      • nasal congestion
    • 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. 

    Ask a doctor before use if

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

    Ask a doctor or pharmacist before use if

    • 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
    • new symptoms occur
    • fever gets worse of 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.

     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. 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

    • do not take more than directed (see overdose warning)
    • 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 at controlled room temperature 15º-30ºC (59º-86ºF)
    • see end flap for expiration date and lot number 
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  • Inactive ingredients

    croscarmellose sodium, croscpovidone, D&C yellow #10, FD&C blue #1, FD&C red #40, FD&C yellow #6, gelatin, hydroxypropyl cellulose, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, shellac glaze, silica gel, stearic acid, titanium dioxide

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  • Questions?

    Call toll free: 1-800-426-9391

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  • Principal Display Panel

    NDC 49035-558-22

    SEE NEW WARNINGS INFORMATION

    equate®

    Compare to Tylenol® Sinus Congestion & Pain Daytime Active Ingredients*

    Sinus
    Congestion
    & Pain 
    Pain Reliever, Nasal Decongestant

    Daytime Non-Drowsy

    • Headache - Acetaminophen
    • Sinus pressure, nasal congestion - Phenylephrine HCl

    48 GELCAPS

    *This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Tylenol® Sinus Congestion & Pain Daytime.

    50844        REV1209B55822

    TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

    Equate 44-558

    Equate 44-558

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  • INGREDIENTS AND APPEARANCE
    SINUS CONGESTION AND PAIN 
    acetaminophen and phenylephrine hcl capsule
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:49035-558
    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
    CROSCARMELLOSE SODIUM  
    CROSPOVIDONE  
    D&C YELLOW NO. 10  
    FD&C BLUE NO. 1  
    FD&C RED NO. 40  
    HYDROXYPROPYL CELLULOSE (TYPE H)  
    HYPROMELLOSES  
    MAGNESIUM STEARATE  
    POLYETHYLENE GLYCOLS  
    STEARIC ACID  
    TITANIUM DIOXIDE  
    Product Characteristics
    Color RED Score score with uneven pieces
    Shape CAPSULE Size 19mm
    Flavor Imprint Code 44;558
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:49035-558-22 1 in 1 CARTON
    1 48 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part343 03/17/2008
    Labeler - Wal-Mart Stores Inc (051957769)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 038154464 PACK(49035-558)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 832867894 MANUFACTURE(49035-558)
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