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SINUS RELIEF Maximum Strength Daytime and Nighttime Sinus Pain

Medically reviewed on February 27, 2018

Dosage form: kit
Ingredients: ACETAMINOPHEN 325mg, GUAIFENESIN 200mg, PHENYLEPHRINE HYDROCHLORIDE 5mg; ACETAMINOPHEN 325mg, DIPHENHYDRAMINE HYDROCHLORIDE 25mg, PHENYLEPHRINE HYDROCHLORIDE 5mg
Labeler: CVS Pharmacy
NDC Code: 59779-881

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.

CVS 44-615544-delisted

Active ingredients (in each caplet)
(Sinus Day)

Acetaminophen 325 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg

Purpose

Pain reliever
Expectorant
Nasal decongestant

Active ingredients (in each caplet)
(Sinus Night)

Acetaminophen 325 mg
Diphenhydramine HCl 25 mg
Phenylephrine HCl 5 mg

Purpose

Pain reliever
Antihistamine
Nasal decongestant

Uses (Sinus Day)
  • temporarily relieves these common cold and flu symptoms:
    • nasal congestion
    • headache
    • minor aches and pains
    • sinus congestion and pressure
  • temporarily promotes 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

Uses (Sinus Night)
  • temporarily relieves these symptoms of hay fever and the common cold:
    • sneezing
    • runny nose
    • headache
    • sore throat
    • nasal congestion
    • minor aches and pains
  • temporarily relieves these additional symptoms of hay fever:
    • itching of the nose or throat
    • itchy, watery eyes

Warnings

Liver warning: This product contains acetaminophen. Severe 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 accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. (Sinus Night only)

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.
  • if you have ever had an allergic reaction to this product or any of its ingredients (Sinus Night only)
  • with any other product containing diphenhydramine, even one used on skin (Sinus Night only)

Ask a doctor before use if you have
  • heart disease
  • liver disease
  • diabetes
  • thyroid disease
  • high blood pressure
  • trouble urinating due to an enlarged prostate gland
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema (Sinus Day only)
  • cough that occurs with too much phlegm (mucus) (Sinus Day only)
  • a breathing problem such as emphysema or chronic bronchitis (Sinus Night only)
  • glaucoma (Sinus Night only)

Ask a doctor or pharmacist before use if you are
  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers (Sinus Night only)

When using this product
  • do not exceed recommended dosage
  • excitability may occur, especially in children (Sinus Night only)
  • marked drowsiness may occur (Sinus Night only)
  • avoid alcoholic drinks (Sinus Night only)
  • alcohol, sedatives, and tranquilizers may increase drowsiness (Sinus Night only)
  • be careful when driving a motor vehicle or operating machinery (Sinus Night only)

Stop use and ask a doctor if
  • nervousness, dizziness, or sleeplessness occur
  • pain 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 gets worse or lasts more than 7 days (Sinus Day only)
  • cough comes back or occurs with rash or headache that lasts (Sinus Day only)

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 (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 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 use

Other information
  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • see end flap for expiration date and lot number

Inactive ingredients (Sinus Day)

corn starch, crospovidone, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silica gel, sodium starch glycolate, stearic acid, talc, titanium dioxide

Inactive ingredients (Sinus Night)

corn starch, croscarmellose sodium, crospovidone, FD&C blue #1 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, silica gel, stearic acid, titanium dioxide, triacetin

Questions or comments?
1-800-426-9391

Principal Display Panel

CVS Health

Compare to the active ingredients in Maximum
Strength Mucinex® SINUS-MAXTM Day & Night*

Sinus Pain

NDC 59779-881-09

DAYTIME
MAXIMUM STRENGTH

Sinus Relief

ACETAMINOPHEN - Pain reliever
GUAIFENESIN - Expectorant
PHENYLEPHRINE HCI - Nasal decongestant

Relieves:
Sinus pressure &
Congestion, Headache
Thins & Loosens mucus

Actual
Size

10 CAPLETS

For Ages 12+

NIGHTTIME
MAXIMUM STRENGTH

Sinus Relief

ACETAMINOPHEN - Pain reliever
DIPHENHYDRAMINE HCI - Antihistamine
PHENYLEPHRINE HCI - Nasal decongestant

Relieves:
Sinus pressure, Pain &
Nasal congestion, Runny
nose & Sneezing

Actual
Size

10 CAPLETS

For Ages 12+

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

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2015 CVS/pharmacy
CVS.com®    1-800-SHOP CVS

V-19849

*This product is not manufactured or distributed by
Reckitt Benckiser LLC, owner of the registered trademark
Maximum Strength Mucinex® SINUS-MAX™ Day & Night.
50844       ORG041361554409

CVS® Quality
Money Back Guarantee

CVS 44-615544 Carton

 

CVS 44-615544 Drug Facts (continued)

 

CVS 44-615544 Drug Facts (continued)

SINUS RELIEF  MAXIMUM STRENGTH DAYTIME AND NIGHTTIME SINUS PAIN
acetaminophen, guaifenesin, diphenhydramine hcl, phenylephrine hcl kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-881
Packaging
#Item CodePackage Description
1NDC:59779-881-091 KIT in 1 PACKAGE, COMBINATION
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BLISTER PACK 10 
Part 21 BLISTER PACK 10 
Part 1 of 2
SINUS RELIEF  MAXIMUM STRENGTH DAYTIME
acetaminophen, guaifenesin, phenylephrine hcl tablet, film coated
Product Information
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN200 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN 
FD&C RED NO. 40 
FD&C YELLOW NO. 6 
MAGNESIUM STEARATE 
MALTODEXTRIN 
CELLULOSE, MICROCRYSTALLINE 
POVIDONE 
SILICON DIOXIDE 
STEARIC ACID 
TALC 
TITANIUM DIOXIDE 
Product Characteristics
ColorORANGEScoreno score
ShapeOVALSize19mm
FlavorImprint Code44;615
Contains    
Packaging
#Item CodePackage Description
110 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34106/30/2013
Part 2 of 2
SINUS RELIEF  MAXIMUM STRENGTH NIGHTTIME
acetaminophen, phenylephrine hcl, diphenhydramine hcl tablet, film coated
Product Information
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN 
CROSCARMELLOSE SODIUM 
FD&C BLUE NO. 1 
HYPROMELLOSES 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYDEXTROSE 
POVIDONE 
SILICON DIOXIDE 
TITANIUM DIOXIDE 
TRIACETIN 
Product Characteristics
ColorBLUEScoreno score
ShapeOVALSize16mm
FlavorImprint Code44;544
Contains    
Packaging
#Item CodePackage Description
110 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34109/19/2006
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34106/30/201311/17/2019
Labeler - CVS Pharmacy (062312574)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(59779-881)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867894MANUFACTURE(59779-881)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867837PACK(59779-881)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.967626305PACK(59779-881)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.868734088PACK(59779-881)

 
CVS Pharmacy

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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