Label: SINUS PRESSURE AND PAIN MAXIMUM STRENGTH- acetaminophen, phenylephrine hcl tablet

  • NDC Code(s): 70000-0161-1
  • Packager: Cardinal Health 110, LLC. DBA Leader
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 18, 2024

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  • Active ingredients (in each caplet)

    Acetaminophen 325 mg
    Phenylephrine HCl 5 mg

  • Purpose

    Pain reliever/fever reducer
    Nasal decongestant

  • Uses

    • temporarily relieves these symptoms associated with hay fever or other upper respiratory allergies, and the common cold:
      • minor aches and pains
      • nasal congestion
      • headache
      • sinus congestion and pressure
    • promotes sinus drainage
    • temporarily reduces fever
  • 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:

    • skin reddening
    • blisters
    • rash

    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

    • heart disease
    • thyroid disease
    • diabetes
    • liver disease
    • high blood pressure
    • difficulty in urination due to enlargement of the 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.

    In case of accidental 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 and over
      • take 2 caplets every 4 hours
      • do not take more than 10 caplets in 24 hours
    • children under 12 years: ask a doctor
  • Other information

    • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
    • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
    • see end flap for expiration date and lot number
  • Inactive ingredients

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

  • Questions or comments?

    1-800-426-9391

  • Principal display panel

    LEADER™

    NDC 70000-0161-1

    Maximum Strength

    Sinus Pressure + Pain  

    Acetaminophen | Pain Reliever / Fever Reducer
    Phenylephrine HCl | Nasal Decongestant

    Non-Drowsy

    Relieves:
    Sinus Headache, Sinus Pressure,
    Nasal Congestion

    24 CAPLETS

     Actual Size

    COMPARE TO
    SUDAFED PE® SINUS
    PRESSURE + PAIN
    active ingredients*

    100% Money Back Guarantee 

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

    CIN 5294335    REV. 3/21

    *This product is not manufactured or distributed by Johnson & Johnson
    Corporation, owner of the registered trademark Sudafed PE® Sinus
    Pressure + Pain         50844        REV0820B50208

    CardinalHealth™

    DISTRIBUTED BY CARDINAL HEALTH
    DUBLIN, OHIO 43017

    www.myleader.com 1-800-200-6313
    Essential to Care™ since 1979

    ©2021 Cardinal Health. All Rights Reserved.
    CARDINAL HEALTH, the Cardinal Health LOGO,
    ESSENTIAL TO CARE, LEADER, and the Leader LOGO
    are trademarks or registered trademarks of
    Cardinal Health. All other marks are property
    of their respective owners.

    100% Money Back Guarantee
    Return to place of purchase if not satisfied.

    Leader 44-502

    Leader 44-502

  • INGREDIENTS AND APPEARANCE
    SINUS PRESSURE AND PAIN  MAXIMUM STRENGTH
    acetaminophen, phenylephrine hcl tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0161
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColororangeScoreno score
    ShapeOVALSize18mm
    FlavorImprint Code 44;502
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70000-0161-12 in 1 CARTON06/23/2005
    112 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01206/23/2005
    Labeler - Cardinal Health 110, LLC. DBA Leader (063997360)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837manufacture(70000-0161) , pack(70000-0161)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.117025878manufacture(70000-0161)
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