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SEVERE COLD AND FLU RELIEF by WOONSOCKET PRESCRIPTION CENTER,INCORPORATED

Dosage form: tablet, film coated
Ingredients: ACETAMINOPHEN 325mg, DEXTROMETHORPHAN HYDROBROMIDE 10mg, GUAIFENESIN 200mg, PHENYLEPHRINE HYDROCHLORIDE 5mg
Labeler: WOONSOCKET PRESCRIPTION CENTER,INCORPORATED
NDC Code: 59779-889

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 44-503C-Delisting

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/flu symptoms:
    • headache
    • cough
    • nasal congestion
    • sore throat
    • minor aches and pains
  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
  • temporarily reduces fever

Warnings

Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 10 caplets (3,250 mg acetaminophen) in 24 hours. 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

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. 
  • 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
  • thyroid disease
  • trouble urinating due to an enlarged prostate gland
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • high blood pressure
  • 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
  • pain, nasal congestion, or cough gets worse or lasts more than 7 days
  • new symptoms occur
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • persistent cough lasts for more than one week, tends to recur, or is accompanied by fever, rash, or persistent headache

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 take more than directed (see overdose warning)
  • adults and children 12 years and over
    • take 2 caplets every 4 hours
    • swallow whole - do not crush, chew, or dissolve
    • do not take more than 10 caplets in 24 hours
  • children under 12 years: ask a doctor

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

Inactive ingredients

corn starch, crospovidone, D&C yellow #10 aluminum lake, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silica gel, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide

Questions or comments?

 1-800-426-9391

Principal Display Panel

♥︎CVSHealth™

Compare to the active ingredients in TYLENOL® Cold & Flu Severe*

Daytime
NDC 59779-889-08
Non-Drowsy

Severe Cold & Flu Relief

ACETAMINOPHEN - Pain reliever, Fever reducer
DEXTROMETHORPHAN HBr
- Cough suppressant
GUAIFENESIN
- Expectorant
PHENYLEPHRINE HCl
- Nasal decongestant

Relieves:
Fever, Headache,
Sore throat, Nasal congestion,
Cough & Chest congestion

24 COOL CAPLETS
      With Cool Blast Flavor

Actual Size

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark TYLENOL® Cold & Flu Severe.
50844    ORG011450308

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

Made in the U.S.A. with domestic and imported ingredients
V-19849

CVS 44-503C-SCFH

SEVERE COLD AND FLU RELIEF 
acetaminophen, dextromethorphan hbr, guiafenesin, phenylephrine hcl tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-889
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
D&C YELLOW NO. 10 
MAGNESIUM STEARATE 
MALTODEXTRIN 
POLYETHYLENE GLYCOLS 
POLYVINYL ALCOHOL 
POVIDONES 
STEARIC ACID 
TALC 
TITANIUM DIOXIDE 
Product Characteristics
ColorYELLOWScoreno score
ShapeOVALSize19mm
FlavorMINTImprint Code44;503
Contains    
Packaging
#Item CodePackage Description
1NDC:59779-889-082 BLISTER PACK in 1 CARTON
112 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34108/04/200511/23/2018
Labeler - WOONSOCKET PRESCRIPTION CENTER,INCORPORATED (062312574)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(59779-889)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867894MANUFACTURE(59779-889)

 
WOONSOCKET PRESCRIPTION CENTER,INCORPORATED

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Medically reviewed on Nov 23, 2018

Further information

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

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