RAPID RELEASE MULTI-SYMPTOM ALLERGY RELIEF (ACETAMINOPHEN, PHENYLEPHRINE HCL, CHLORPHENIRAMINE MALEATE) CAPSULE, GELATIN COATED [WAL-MART STORES INC]

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  • RAPID RELEASE MULTI-SYMPTOM ALLERGY RELIEF (ACETAMINOPHEN, PHENYLEPHRINE HCL, CHLORPHENIRAMINE MALEATE) CAPSULE, GELATIN COATED [WAL-MART STORES INC]

RAPID RELEASE MULTI-SYMPTOM ALLERGY RELIEF (ACETAMINOPHEN, PHENYLEPHRINE HCL, CHLORPHENIRAMINE MALEATE) CAPSULE, GELATIN COATED [WAL-MART STORES INC]
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NDC 49035-559-08
Set ID 7fc09c01-a822-4b8b-a967-dcc7048d226c
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 gelcap)

    Acetaminophen 325 mg
    Chlorpheniramine maleate 2 mg
    Phenylepherine HCl 5 mg

  • Purpose

    Pain reliever
    Antihistamine
    Nasal decongestant 

  • Uses

    • temporarily relieves these symptoms of hay fever or other upper respiratory allergies:
      • sinus congestion and pressure
      • nasal congestion
      • runny nose and sneezing
      • headache
      • minor aches and pains
    • temporarily relieves these additional symptoms of hay fever
      • itching of the nose or throat
      • itchy, watery eyes
    • helps clear nasal passages
    • helps decongest sinus openings and passages
  • 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 taking 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

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

    Ask a doctor or pharmacist before use if you are

    • taking the blood thinning drug warfarin
    • taking sedatives or tranquilizers

    When using this product

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

    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
    • new symptoms occur
    • 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 (1-800-222-1222) right away.  Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • 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
  • Other information

    • see end flap for expiration date and lot number
    • store at 25ºC (77º); excursions permitted between 15º to 30ºC (59º-86ºF)
    • contains FD&C yellow #5 (tartrazine) as a color additive
  • Inactive ingredients

    croscarmellose sodium, crospovidone, FD&C red #3, FD&C red #40, FD&C yellow #5, 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

  • Questions?

    1-888-287-1915

  • Principal display panel

    NDC 49035-559-08

    equate®

    Compare to Tylenol® Allergy Multi-Symptom Active Ingredients*

    Rapid Release
    Multi-Symptom
    Allergy Relief
    Pain reliever, Nasal decongestant, Antihistamine

    Contains 3 medicines
    • Headache - Acetaminophen
    • Sinus pressure/Nasal Congestion - Phenylephrine HCl
    • Runny nose/Sneezing
       Itchy, Watery eyes - Chlorpheniramine maleate

    Pseudoephedrine Free

    24
    GELCAPS

    Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716 
    ©Wal-Mart Stores, Inc.

    *This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Tylenol® Allergy Multi-Symptom.
    50844        REV0812A55908

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

    Equate 44-559

    Equate 44-559

  • INGREDIENTS AND APPEARANCE
    RAPID RELEASE MULTI-SYMPTOM ALLERGY RELIEF 
    acetaminophen, phenylephrine hcl, chlorpheniramine maleate capsule, gelatin coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-559
    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
    CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE2 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    GELATIN (UNII: 2G86QN327L)  
    Product Characteristics
    ColorYELLOW (red with grey band) Scoreno score
    ShapeCAPSULESize19mm
    FlavorImprint Code L;9
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49035-559-081 in 1 CARTON
    124 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34103/17/2008
    Labeler - Wal-Mart Stores Inc (051957769)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464PACK(49035-559)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894MANUFACTURE(49035-559)
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