ALLERGY AND PAIN RELIEF MULTI-SYMPTOM (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) TABLET, FILM COATED [WINCO FOODS, LLC]

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  • ALLERGY AND PAIN RELIEF MULTI-SYMPTOM (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) TABLET, FILM COATED [WINCO FOODS, LLC]

ALLERGY AND PAIN RELIEF MULTI-SYMPTOM (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) TABLET, FILM COATED [WINCO FOODS, LLC]
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NDC 67091-210-24
Set ID 08b95554-0063-46d4-b639-c2aa28791274
Category HUMAN OTC DRUG LABEL
Packager WinCo Foods, LLC
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
    Chlorpheniramine maleate 2 mg
    Phenylephrine HCl 5 mg 

  • Purpose

    Pain reliever
    Antihistamine
    Nasal decongestant 

  • Uses

    • temporarily relieves these symptoms of hay fever or other upper respiratory allergies:
      • headache
      • nasal congestion
      • runny nose and sneezing
      • minor aches and pains
      • sinus congestion and pressure
    • temporarily relieves these additional symptoms of hay fever:
      • itchy, watery eyes
      • itching of the nose or throat
    • 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 4,000 mg 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 

    Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

    • blisters
    • rash
    • skin reddening

    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

    • difficulty in urination due to enlargement of the prostate gland
    • glaucoma
    • high blood pressure
    • a breathing problem such as emphysema or chronic bronchitis
    • heart disease
    • thyroid disease
    • diabetes
    • liver disease

    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 beverages
    • use caution when driving a motor vehicle or operating machinery
    • may cause drowsiness

    Stop use and ask a doctor if

    • nervousness, dizziness, or sleeplessness occur
    • pain or nasal congestion gets worse or lasts more than 7 days
    • new symptoms occur
    • fever gets worse or lasts more than 3 days
    • redness or swelling is present

    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 take more than directed
    • adults and children 12 years and over
      • take 2 caplets every 4 hours
      • swallow whole - do not crush, chew, or dissolve
      • 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, crospovidone, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silica gel, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide 

  • Questions?

    Call 800-824-1706 Monday - Friday 9am - 4pm MST 

  • Principal Display Panel

     *Compare to the active ingredients in TYLENOL® Allergy Multi-Symptom

    WinCo®
    FOODS

    MULTI-SYMPTOM
    Allergy &
    Pain Relief 

    ACETAMINOPHEN / PAIN RELIEVER
    CHLORPHENIRAMINE MALEATE / ANTIHISTAMINE
    PHENYLEPHRINE HCl / NASAL DECONGESTANT

    Relieves: Sinus Headache, Runny Nose & Sneezing,
    Sinus Pressure, Itchy & Watery Eyes
    and Nasal Congestion

    24
    Caplets

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

    DISTRIBUTED BY: WINCO FOODS, LLC, BOISE, ID 83704

    *This product is not manufactured or distributed by MCNEIL CONSUMER HEALTHCARE, distributor of TYLENOL® Allergy Multi-Symptom.

    50844     REV0616B45508     WF1612

    100% SATISFACTION GUARANTEE

    Comments & Questions?
    800-824-1706

    Winco 44-455C-AMS

    Winco 44-455C-AMS

  • INGREDIENTS AND APPEARANCE
    ALLERGY AND PAIN RELIEF  MULTI-SYMPTOM
    acetaminophen, chlorpheniramine maleate, phenylephrine hcl tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67091-210
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE2 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeOVALSize17mm
    FlavorImprint Code 44;455
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67091-210-242 in 1 CARTON06/28/2005
    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 FINALpart34106/28/2005
    Labeler - WinCo Foods, LLC (056098817)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464PACK(67091-210)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894MANUFACTURE(67091-210)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305PACK(67091-210)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837PACK(67091-210)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088PACK(67091-210)
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