Label: SINUS HEADACHE PE- acetaminophen and phenylephrine hydrochloride tablet 

  • Label RSS
  • 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 02/13

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

  • Active ingredients (in each caplet)

    Acetaminophen 325 mg
    Phenylephrine HCl 5 mg

    Close
  • Purpose

    Pain reliever
    Nasal decongestant 

    Close
  • Uses

    • temporarily relieves headache, minor aches and pains
    • temporarily relieves nasal congestion 
    Close
  • Warnings

     Liver warning: This product containsa acetaminophen. Severe liver damage may occur if you take:

    • more than 12 caplets 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 an 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

    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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

    Close
  • Directions

    • do not use more than directed
      (see overdose warning)
    • adults and children 12 ears and over
      • take 2 caplets every 4 hours
      • do not take more than 12 caplets 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. 
    Close
  • Other information

    • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
    • see end flap for expiration date and lot number
    Close
  • Inactive ingredients

    corn starch, croscarmellose sodium, crospovidone, FD&C yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose, povidone, silica gel, stearic acid

    Close
  • Questions or comments?

    1-877-932-7948

    Close
  • Principal Display Panel

    equaline

    compare to the active ingredients in Sudafed PE® Pressure + Pain*

    NDC 41163-502-08

    non-drowsy, maximum strength
    sinus headache PE
    acetaminophen and phenylephrine HCl
    pain reliever, nasal decongestant

    sinus pain & headache
    • sinus pressure
    • nasal & sinus congestion

    pseudoephedrine free

    24 caplets

    DOES NOT CONTAIN GLUTEN

    *This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Sudafed PE® Pressure + Pain.
    50844    REV0410B50208

    DISTRIBUTED BY SUPERVALU INC.
    EDEN PRARITE, MN 55344 USA

    TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERINGequaline 44-502

    equaline 44-502

    Close
  • INGREDIENTS AND APPEARANCE
    SINUS HEADACHE PE 
    acetaminophen and phenylephrine hcl tablet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:41163-502
    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  
    FD&C YELLOW NO. 6  
    MAGNESIUM STEARATE  
    POVIDONES  
    STEARIC ACID  
    Product Characteristics
    Color ORANGE Score no score
    Shape CAPSULE Size 17mm
    Flavor Imprint Code 44;502
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:41163-502-08 1 in 1 CARTON
    1 24 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part343 06/23/2005
    Labeler - SUPERVALU INC. (006961411)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 038154464 PACK(41163-502)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 832867894 MANUFACTURE(41163-502)
    Close