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

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  • SUPHEDRINE PE (CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HCL) TABLET [WAL-MART STORES INC]

SUPHEDRINE PE (CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HCL) TABLET [WAL-MART STORES INC]
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NDC 49035-462-08, 49035-462-43
Set ID 47641a71-feec-4c9f-972b-15c22f8df736
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 tablet)

    Chlorpheniramine maleate 4 mg
    Phenylephrine HCl 10 mg

  • Purpose

    Antihistamine
    Nasal decongestant

  • Uses

    • temporarily relieves these symptoms due to hay fever (allergic rhinitis) or other upper respiratory allergies:
      • runny nose
      • sneezing
      • itching of the nose or throat
      • itchy, watery eyes
      • sinus congestion and pressure
      • nasal congestion
  • Warnings

    Do not use

    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 you have

    • high blood pressure
    • heart disease
    • thyroid disease
    • diabetes
    • glaucoma
    • a breathing problem such as emphysema or chronic bronchitis
    • trouble urinating due to an enlarged prostate gland

    Ask a doctor or pharmacist before use if you are

    taking sedatives or tranquilizers.

    When using this product

    • do not exceed recommended dose
    • excitability may occur, especially in children
    • drowsiness may occur
    • avoid alcoholic drinks
    • alcohol, sedatives and tranquilizers may increase drowsiness
    • be careful when driving a motor vehicle or operating machinery

    Stop use and ask a doctor if

    • nervousness, dizziness, or sleeplessness occur
    • symptoms do not improve within 7 days or occur with a fever

    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • Directions

    • adults and children 12 years and over: take 1 tablet every 4 hours. Do not take more than 6 tablets in 24 hours.
    • children under 12 years: do not use this product in children under 12 years of age
  • Other information

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

    croscarmellose sodium, lactose, magnesium stearate, microcrystalline cellulose, silica gel, stearic acid

  • Questions or comments?

    1-888-287-1915

  • Principal display panel

    equate™

    NDC 49035-462-08

    Compare to
    Sudafed PE®
    Sinus + Allergy
    Active
    Ingredients*

    Sinus & Allergy

    Suphedrine PE
    Chlorpheniramine maleate and Phenylephrine HCl
    Antihistamine, Nasal Decongestant

    Relieves:
    • Sinus pressure & congestion
    • Sneezing, itchy eyes & runny nose

    Maximum Strength

    24
    TABLETS

    Actual Size

    TAMPER EVIDENT: DO NOT USE IF CARTON 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® Sinus + Allergy.
    50844    ORG061246208

    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 1-800-287-1915.

    Equate 44-462

    Equate 44-462

  • INGREDIENTS AND APPEARANCE
    SUPHEDRINE PE 
    chlorpheniramine maleate and phenylephrine hcl tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-462
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE4 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize7mm
    FlavorImprint Code 44;462
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49035-462-081 in 1 CARTON06/09/200510/01/2023
    1NDC:49035-462-4324 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34106/09/200510/01/2023
    Labeler - Wal-Mart Stores Inc (051957769)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837pack(49035-462)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894manufacture(49035-462)
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