MUCUS RELIEF COLD FLU SORE THROAT MAXIMUM STRENGTH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [WALGREENS]

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  • MUCUS RELIEF COLD FLU SORE THROAT MAXIMUM STRENGTH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [WALGREENS]

MUCUS RELIEF COLD FLU SORE THROAT MAXIMUM STRENGTH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [WALGREENS]
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NDC 0363-0719-16
Set ID a251f010-7ab9-44af-9ed1-9b0071a081fb
Category HUMAN OTC DRUG LABEL
Packager Walgreens
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
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  • Active ingredients (in each softgel)

    Acetaminophen 325 mg 

    Dextromethorphan HBr 10 mg

    Guaifenesin 200 mg

    Phenylephrine HCl 5 mg

  • Purposes

    Pain reliever/fever reducer 

    Cough suppressant

    Expectorant

    Nasal decongestant

  • Uses

    • temporarily relieves these common cold and flu symptoms:
      • headache
      • nasal congestion
      • sore throat
      • cough
      • minor aches and pains
      • temporarily reduces fever
    • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
  • Warnings

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

    • more than 4,000 of acetaminophen  in 24 hours
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks everyday 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.

    Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied 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 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

    • liver disease
    • diabetes
    • high blood pressure
    • heart disease
    • thyroid
    • trouble urinating due to an enlarges 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 use more than directed.

    Stop use and ask a doctor if

    • nervousness, dizziness or sleeplessness occur
    • new symptoms occur
    • pain, nasal congestion or cough gets worse or lasts more than 7 days
    • fever gets worse or lasts more than 3 days
    • redness or swelling is present
    • 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 take more than directed (see Overdose warning)
    • do not take more than 12 softgels in any 24-hour period
    • adults and children 12 years of age and older: take 2 softgels every 4 hours
    • children under 12 years of age: do not use

  • Other information

    • swallow whole: do not crush, chew, or dissolve
    • avoid excessive heat
    • store between 15-30ºC (59-86ºF)
  • Inactive ingredients

    FD&C red #40, FD&C yellow #6 gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol, sorbitan, titanium dioxide

  • Questions or comments?

     Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

  • Principal Display Panel

    Compare to Maximum Strength Mucinex® Fast-Max® Cold, Flu & Sore Throat active ingredient††

    Cold, Flu & Sore Throat

    ACETAMINOPHEN / PAIN RELIEVER / FEVER REDUCER

    DEXTROMETHORPHAN HBr / COUGH SUPPRESSANT

    GUAIFENESIN / EXPECTORANT

    PHENYLEPHRINE HCI / NASAL DECONGESTANT

    MAXIMUM STRENGTH

    ALCOHOL FREE

    • Relieves fever, sore throat, chest congestion & stuffy nose 
    • Controls cough
    • Thins & loosens mucus
    • For ages 12 & over

    SOFTGELS*

    (*LIQUID-FILLES CAPSULES)

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

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

    ††This product is not manufactured or distributed by Reckitt Benckiser, distributor of Maximum Strength Mucinex® Fast-Max® Cold, Flu & Sore Throat.

    DISTRIBUTED BY: WALGREEN CO.

    200 WILMOT RD., DEERFIELD, IL 60015

    walgreens.com

  • Package Label

    Acetaminophen 325 mg, Dextromethorphan HBr 10 mg, Guaifenesin 200 mg, Phenylephrine HCI 5 mg

    WALGREENS Cold, Flu & Sore Throat Maximum Strength

  • INGREDIENTS AND APPEARANCE
    MUCUS RELIEF COLD FLU SORE THROAT  MAXIMUM STRENGTH
    acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0719
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    GELATIN (UNII: 2G86QN327L)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    SORBITAN (UNII: 6O92ICV9RU)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    ColorORANGEScoreno score
    ShapeCAPSULESize20mm
    FlavorImprint Code 341
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-0719-1616 in 1 CARTON05/31/201612/30/2022
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34105/31/201612/30/2022
    Labeler - Walgreens (008965063)
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