SINUS RELIEF SEVERE CONGESTION MAXIMUM STRENGTH- acetaminophen, guaifenesin, phenylephrine hcl tablet, film coated 
CVS Pharmacy

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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CVS 44-615-SMH

Active ingredients (in each caplet)

Acetaminophen 325 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg

Purpose

Pain reliever
Expectorant
Nasal decongestant 

Uses

Warnings

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

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

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.
  • If you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have

  • liver disease
  • thyroid disease
  • diabetes
  • heart disease
  • high blood pressure
  • difficulty in urination due to enlargement of the 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 exceed recommended dosage.

Stop use and ask a doctor if

  • nervousness, dizziness, or sleeplessness occur
  • fever gets worse or lasts more than 3 days
  • pain, nasal congestion, or cough gets worse or lasts more than 7 days
  • redness or swelling is present
  • new symptoms occur
  • 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.

In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

Other information

Inactive ingredients

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, silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide

Questions or comments?

1-800-426-9391

Principal display panel

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Health

Compare to the active ingredients in Maximum Strength Mucinex® SINUS-MAX® Severe Congestion Relief*

NDC 59779-515-09

MAXIMUM STRENGTH
Sinus Relief
Severe Congestion

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

Relieves:
• Headache
• Nasal & Chest congestion
Thins & Loosens mucus

20 CAPLETS   Ages 12 Years & Over

Actual Size

*This product is not manufactured or distributed by Reckitt Benckiser LLC, owner of the registered trademark Maximum Strength Mucinex® SINUS-MAX® Severe Congestion Relief.                50844    REV0117A61509

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
© 2017 CVS/pharmacy
CVS.com    1-800-SHOP  CVS  
V-19849

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Money Back Guarantee

CVS 44-615

CVS 44-615

SINUS RELIEF SEVERE CONGESTION  MAXIMUM STRENGTH
acetaminophen, guaifenesin, phenylephrine hcl tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-515
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
Product Characteristics
ColororangeScoreno score
ShapeOVALSize19mm
FlavorImprint Code 44;615
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59779-515-092 in 1 CARTON06/30/2014
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34106/30/2014
Labeler - CVS Pharmacy (062312574)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464pack(59779-515)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894manufacture(59779-515)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.967626305pack(59779-515)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867837pack(59779-515)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.868734088pack(59779-515)

Revised: 4/2021
Document Id: 39884fb5-bee6-4da7-a008-d93114a401a0
Set id: 38651b17-40cd-4eed-b3be-f713837917c0
Version: 7
Effective Time: 20210430
 
CVS Pharmacy