SINUS RELIEF MAXIMUM STRENGTH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [WALGREENS]

SINUS RELIEF MAXIMUM STRENGTH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [WALGREENS]
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NDC 0363-0524-16
Set ID 3e400572-c983-4f68-b0ca-b90a1a2329c1
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 for

    Pain reliever

    Cough suppressant

    Expectorant

    Nasal decongestant

  • Uses

    • temporarily relieves
      • cough due to inhaled irritants
      • nasal congestion
      • sinus congestion and pressure
      • headache
      • minor aches and pains
    • promotes nasal and or sinus drainage
    • help loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make cough 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

    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 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 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
    • 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, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol, titanium dioxide

  • 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 DECONGESTANT

    MAXIMUM STRENGTH

    • Relieves sinus congestion & headache
    • 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 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.

    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

  • INGREDIENTS AND APPEARANCE
    SINUS RELIEF  MAXIMUM STRENGTH
    acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0524
    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)  
    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
    ShapeCAPSULESize20mm
    FlavorImprint Code 341
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-0524-162 in 1 CARTON04/30/201705/31/2024
    18 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34104/30/201705/31/2024
    Labeler - Walgreens (008965063)

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