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PE multi-stymptom cold and cough relief (Target Corporation)

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CAPSULE, COATED 1 BLISTER PACK in 1 CARTON (11673-645-09) > 20 CAPSULE, COATED in 1 BLISTER PACK Label Information

Complete PE multi-stymptom cold and cough relief Information

  • Active ingredients (in each caplet)

    Acetaminophen 325 mg
    Dextromathorphan HBr 10 mg
    Guaifenesin 100 mg
    Phenylephrine HCl 5 mg


  • Purpose

    Pain reliever/fever reducer
    Cough suppressant
    Expectorant
    Nasal decongestant


  • Uses

    •  temporarily relieves these symptoms due to the common cold:
      • nasal congestion
      • headache
      • minor aches and pains
      • cough
      • sore throat
    • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
    • temporarily reduces fever

  • Warnings

     Liver warning: This product contains acetaminophen.  Sever liver damage may occur if you take:

    • more than 12 caplets 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

    Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompained or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

    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 shopping the 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
    •  liver disease
    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • trouble urinating due to an enlarged prostate gland
    • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
    • cough that occurs with too much phlegm (mucus)

    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, cough, 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
    • cough comes back or occurs with rash or headache that lasts

    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 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 use more than directed (see overdose warning)
    • adults and children 12 years and over
      • take 2 caplets every 4 hours
      • do not take more than 12 caplets in 24 hours
    • children under 12 years: do not uses 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

    • store at controlled room temperature 15º-30ºC (59º-86ºF)
    • see end flap for expiration date or lot number

  • Inactive ingredients

    corn starch, crospovidone, FD&C yellow #6 aluminum lake, magnesium stearate, maletodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silica gel, sodium starch glycolate, stearic acid, talc, titanium dioxide


  • Questions?

    1-800-910-6874


  • Principal Display Panel

    NDC 11673-645-09

    PE multi-symptom cold and cough relief
    non-drowsy
    acetaminophen, dextromethorphan HBr
    guafenesin, phenylephrine HCl

    Compare to active ingredient in Sudafed PE® Cold & Cough*

    relieves cough and sore throat/fever/minor aches and pains/chest congestion/nasal and sinus congestion

    up & up®

    20 COATED CAPLETS SHOWN ACTUAL SIZE ABOVE

    *This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Sudafed PE® Cold & Cough..
    50844    REV0712E54609

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

    Target 44-546

    Target 44-546


  • INGREDIENTS AND APPEARANCE
    PE MULTI-STYMPTOM COLD AND COUGH RELIEF 
    acetaminophen, dextromathorphan hbr, gauifenesin, phenylephrine hcl capsule, coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:11673-645
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 100 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg
    Inactive Ingredients
    Ingredient Name Strength
    CORN STARCH 3-E-DODECENYL SUCCINIC ANHYDRIDE MODIFIED (UNII: QG4MW19XYX)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL (UNII: 532B59J990)  
    POVIDONES (UNII: FZ989GH94E)  
    DIATOMACEOUS EARTH (UNII: 2RF6EJ0M85)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Color ORANGE Score no score
    Shape CAPSULE Size 17mm
    Flavor Imprint Code 44;546
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:11673-645-09 2 in 1 CARTON
    1 10 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part341 02/22/2007 11/04/2018
    Labeler - Target Corporation (006961700)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 038154464 PACK(11673-645)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 832867894 MANUFACTURE(11673-645)