MUCUS RELIEF SEVERE SINUS CONGESTION (ACETAMINOPHEN DEXTROMETHORPHAN HBR GUAIFENESIN PHENYLEPHRINE HCI) CAPSULE [WALGREENS]

MUCUS RELIEF SEVERE SINUS CONGESTION (ACETAMINOPHEN DEXTROMETHORPHAN HBR GUAIFENESIN PHENYLEPHRINE HCI) CAPSULE [WALGREENS]
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NDC 0363-0840-16
Set ID e1f8cf03-d4fc-42b3-aada-efc3ffd8e1ba
Category HUMAN OTC DRUG LABEL
Packager Walgreens
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
  • Active ingredients (in each softgel)

    Acetaminophen 325 mg

    Dextromethorphan HBr 10 mg

    Guaifenesin 200 mg

    Phenylephrine HCl 5 mg

  • Purpose

    Pain reliever

    Cough suppressant

    Expectorant

    Nasal decongestant

  • Uses

    DAYTIME

    • temporarily relieves
      • cough due to inhaled irritants
      • nasal congestion
      • headache
      • sinus congestion and pressure
      • minor aches and pains
      • promoted nasal and/or sinus drainage
      • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
  • Warnings

    Liver warning: These products contain acetaminophen. Severe liver damage may occur if you take:

    • more than 4,000 mg of acetaminophen in 24 hours
    • 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:

    • 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

    DAYTIME

    • liver disease
    • diabetes
    • high blood pressure
    • heart disease
    • thyroid disease
    • trouble urinating due to an enlarged prostate gland
    • a 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
    • 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
    • new symptoms occur
    • cough comes back or occurs with rash or headache that lasts. These coukld 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 can 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)
    • 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
    • store between 15-30ºC (59-86F)
    • avoid excessive heat
  • Inactive ingredients

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

    *may contain this ingredient

  • Questions or comments?

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

  • Principal Display Panel

    Compare to Maximum Strength Mucinex® Sinus-Max® Severe Congestion Relief active ingredients††

    Severe Sinus Congestion

    ACETAMINOPHEN 325 mg / PAIN RELIEVER

    DEXTROMETHORPHAN HBr 10 mg / COUGH SUPPRESSANT

    GUAIFENESIN 200 mg / EXPECTORANT

    PHENYLEPHRINE HCI 5 mg / NASAL DECONGESTION

    MAXIMUM STRENGTH

    • Relieves sinus congestion & headsache
    • Thins & loosens mucus
    • Controls cough
    • Ages 12  & older
    • Alcohol free

    SOFTGELS**

    (**LIQUID-FILLED CAPSULES)

    ††This product is not manufactured or distributed by Reckitt Benckiser, distributor of Maximum Strength Mucinex® Sinus-Max®  Severe Congestion Relief.

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

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

    DISTRIBUTED BY: WALGREEN CO.

    200 WILMOT RD., DEERFIELD, IL 60015

    walgreens.com

  • Product Label

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

    WALGREENS Severe Sinus Congestion Softgels

  • INGREDIENTS AND APPEARANCE
    MUCUS RELIEF SEVERE SINUS CONGESTION 
    acetaminophen dextromethorphan hbr guaifenesin phenylephrine hci capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0840
    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
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MANNITOL (UNII: 3OWL53L36A)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITAN (UNII: 6O92ICV9RU)  
    SORBITOL (UNII: 506T60A25R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColororangeScoreno score
    ShapeOVALSize20mm
    FlavorImprint Code 341;12A
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-0840-1616 in 1 CARTON12/31/201804/30/2023
    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 finalpart34112/31/201804/30/2023
    Labeler - Walgreens (008965063)

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