MUCUS RELIEF SEVERE SINUS CONGESTION- acetaminophen dextromethorphan hbr guaifenesin phenylephrine hci capsule 
Walgreens

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

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

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)

Revised: 11/2021
 
Walgreens