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Severe Congestion and Cold Maximum Strength

Medically reviewed by Drugs.com. Last updated on Apr 28, 2021.

Dosage form: tablet, film coated
Ingredients: ACETAMINOPHEN 325mg, DEXTROMETHORPHAN HYDROBROMIDE 10mg, GUAIFENESIN 200mg, PHENYLEPHRINE HYDROCHLORIDE 5mg
Labeler: CVS Pharmacy
NDC Code: 59779-761

CVS 44-617-delisted

Active ingredients (in each caplet)

Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer
Cough suppressant
Expectorant
Nasal decongestant 

Uses
  • temporarily relieves these common cold and flu symptoms:
    • nasal congestion
    • cough
    • headache
    • minor aches and pains
    • sinus congestion and pressure
  • temporarily reduces fever
  • 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

Warnings

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

  • more than 4,000 mg in 24 hours, which is the maximum daily amount
  • 3 or more alcoholic drinks every day while using this product 
  • with other drugs containing acetaminophen

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

  • blisters
  • rash
  • skin reddening

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

Stop use and ask a doctor if
  • new symptoms occur
  • pain, nasal congestion, or cough gets worse or lasts more than 7 days
  • redness or swelling is present
  • nervousness, dizziness, or sleeplessness occur
  • fever gets worse or lasts more than 3 days
  • 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
  • do not take more than directed
  • do not take more than 12 caplets in any 24-hour period
  • adults and children 12 years and over: take 2 caplets every 4 hours
  • children under 12 years : do not use

Other information
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • use by expiration date on package

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

♥︎CVS
Health™

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

Compare to the active ingredients in Mucinex®*

NDC 59779-761-01

Severe
Congestion
& Cold

Acetaminophen - Pain reliever, Fever reducer
Dextromethorphan HBr - Cough suppressant
Guaifenesin - Expectorant
Phenylephrine HCl - Nasal decongestant

MAXIMUM STRENGTH

Relieves:
Headache, Fever, Nasal
& Chest congestion

Controls cough
Thins & Loosens mucus

For Ages 12+

30 CAPLETS

*This product is not manufactured or distributed by Reckitt Benckiser LLC, owner of the registered trademark Mucinex®.

50844           REV0317A61701

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2017 CVS/pharmacy
CVS.com®    1-800-SHOP CVS    V-19849

CVS® Quality
Money Back Guarantee 

CVS 44-617

SEVERE CONGESTION AND COLD  MAXIMUM STRENGTH
acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-761
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE10 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 
TITANIUM DIOXIDE 
TALC 
POVIDONE 
STEARIC ACID 
MICROCRYSTALLINE CELLULOSE 
SILICON DIOXIDE 
CROSPOVIDONE 
POLYETHYLENE GLYCOL, UNSPECIFIED 
POLYVINYL ALCOHOL, UNSPECIFIED 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
Product Characteristics
ColorREDScoreno score
ShapeOVALSize19mm
FlavorImprint Code44;617
Contains    
Packaging
#Item CodePackage Description
1NDC:59779-761-013 BLISTER PACK in 1 PACKAGE
110 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34104/07/201302/21/2022
Labeler - CVS Pharmacy (062312574)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(59779-761)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867894MANUFACTURE(59779-761)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.967626305PACK(59779-761)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867837PACK(59779-761)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.868734088PACK(59779-761)

 
CVS Pharmacy

Further information

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