SUPHEDRINE PE (ACETAMINOPHEN AND PHENYLEPHRINE HCL) TABLET [WAL-MART STORES INC]

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SUPHEDRINE PE (ACETAMINOPHEN AND PHENYLEPHRINE HCL) TABLET [WAL-MART STORES INC]
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NDC 49035-502-08, 49035-502-42
Set ID 76383d33-4122-4fae-a95d-830518c4f5e9
Category HUMAN OTC DRUG LABEL
Packager Wal-Mart Stores Inc
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
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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. The maximum daily dose of this product is 10 caplets (3,250 mg) in 24 hours. 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

    • diabetes
    • liver disease
    • heart disease
    • thyroid 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 (1-800-222-1222) 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 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
    • 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, silica gel, stearic acid

  • Questions or comments?

    1-888-287-1915

  • Principal Display Panel

    NDC 49035-502-08

    equate™

    Compare to
    Sudafed PE®
    Pressure + Pain
    Active
    Ingredients*

    Pressure & Pain
    Suphedrine PE
    Acetaminophen     and Phenylephrine HCl
    Pain Reliever, Fever Reducer, Nasal Decongestant

    Non-Drowsy

    Relieves:
    • Sinus pressure & congestion
    • Sinus headache & pain

    Maximum Strength

    24
    CAPLETS

    Actual Size

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

    DISTRIBUTED BY: Wal-Mart Stores, Inc.,
    Bentonville, AR 72716 

    *This product is not manufactured or
    distributed by McNeil Consumer Healthcare,
    owner of the registered trademark Sudafed
    PE® Pressure + Pain.
    50844                   REV0915B50208

    Satisfaction guaranteed -
    Or we'll replace it or give
    you your money back.
    For questions or comments
    or to report an undesired
    reaction or side effect,
    please call 1-888-287-1915.

    Equate 44-502

    Equate 44-502

  • INGREDIENTS AND APPEARANCE
    SUPHEDRINE PE 
    acetaminophen and phenylephrine hcl tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-502
    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
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    ColororangeScoreno score
    ShapeOVALSize18mm
    FlavorImprint Code 44;502
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49035-502-082 in 1 CARTON06/23/200506/26/2023
    112 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:49035-502-4212 in 1 BLISTER PACK; Type 0: Not a Combination Product06/23/200506/26/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34106/23/200506/26/2023
    Labeler - Wal-Mart Stores Inc (051957769)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894manufacture(49035-502)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837pack(49035-502)
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