SEVERE COLD AND FLU RELIEF description, usages, side effects, indications, overdosage, supplying and lots more!

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SEVERE COLD AND FLU RELIEF

WOONSOCKET PRESCRIPTION CENTER,INCORPORATED

CVS 44-503C




FULL PRESCRIBING INFORMATION

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

Pain reliever/fever reducer
Cough suppressant
Expectorant
Nasal decongestant

  • 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

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.

  • 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
  • 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)

taking the blood thinning drug warfarin.

do not exceed recommended dosage.
  • 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. 

ask a health professional before use.

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.

  • 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
  • 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 

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

 1-800-426-9391

CVS
pharmacy™

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

NON-DROWSY

SEVERE
COLD & FLU RELEIF
DAYTIME

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
© 2014 CVS/pharmacy      CVS.com®    1-800-SHOP  CVS

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

SEVERE COLD AND FLU RELIEF

CVS-44-503C

SEVERE COLD AND FLU RELIEF

Acetaminophen, Phenylephrine HCl, Dextromethorphan HBr, Guiafenesin TABLET, FILM COATED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:59779-889
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 325 mg
DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN 10 mg
Guaifenesin GUAIFENESIN 200 mg
Phenylephrine Hydrochloride PHENYLEPHRINE 5 mg

Inactive Ingredients

Ingredient Name Strength
CROSPOVIDONE
D&C YELLOW NO. 10
MAGNESIUM STEARATE
maltodextrin
POLYETHYLENE GLYCOLS
POLYVINYL ALCOHOL
POVIDONES
STEARIC ACID
talc
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
YELLOW 19 mm 44;503 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 12 in 1 BLISTER PACK
2 NDC:59779-889-08 2 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2005-08-04


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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