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Non Drowsy Cold and Cough PE by WOONSOCKET PRESCRIPTION CENTER,INCORPORATED

Medically reviewed on August 20, 2018

Dosage form: capsule, coated
Ingredients: ACETAMINOPHEN 325mg, DEXTROMETHORPHAN HYDROBROMIDE 10mg, GUAIFENESIN 100mg, PHENYLEPHRINE HYDROCHLORIDE 5mg
Labeler: WOONSOCKET PRESCRIPTION CENTER,INCORPORATED
NDC Code: 59779-799

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 44-546

Active ingredients

 Acetaminophen 325 mg

Dextromathorphan HBr 10 mg

Guaifenesin 100 mg

Phenylephrine HCl 5 mg

Purpose

 Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

Uses
  •  temporarily relieves these symptoms due to the common cold:
    • nasal congestion
    • headache
    • minor aches and pains
    • cough
    • sore throat
  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
  • temporarily reduces fever

Warnings

 Liver warning: This product contains acetaminophen.  Sever 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 accompained 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 shopping the 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
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged 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
  • pain, cough, 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 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.

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 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 uses this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage

Other information
  •  store at controlled room temperature 15º-30ºC (59º-86ºF)
  • see end flap for expiration date or lot number

Inactive ingredients

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

Questions or comments?

 1-800-426-9391

Principal Display Panel

 The product packaging shown below represents a sample of that currently in use.  Additional packaging may also be available.

CVS®

pharmacy

NDC 59779-546-03

Compare to the active ingredients in Sudafed PE® Cold & Cough*

NON-DROWSY

COUGH & COLD PE

MULTI-SYMPTOM

ACETAMINOPHEN, DEXTROMATHORPHAN HBr

GUAIFENESIN, PHENYLEPHRINE HCl

PAIN RELIEVER/FEVER REDUCER, EXPECTORANT

COUGH SUPPRESSANT, NASAL DECONGESTANT

•Nasal & sinus congestion

•Chest congestion

•Fever & body aches

•Cough & sore throat

Does not contain Pseudoephedrine

* This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Sudafed ® PE Cold & Cough.

50844    REV0510B54603

Distributed by: CVS Pharmacy, Inc.

One CVS Ddrive, Woonsocket, RI 02895

© 2010 CVS/pharmacy

NON DROWSY COLD AND COUGH PE 
acetaminophen, dextromathorphan hbr, gauifenesin, phenylephrine hcl capsule, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-799
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE10 mg
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN100 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
CORN STARCH 3-E-DODECENYL SUCCINIC ANHYDRIDE MODIFIED 
CROSPOVIDONE 
MAGNESIUM STEARATE 
MALTODEXTRIN 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOL 
POLYVINYL ALCOHOL 
POVIDONE 
DIATOMACEOUS EARTH 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
STEARIC ACID 
TALC 
TITANIUM DIOXIDE 
Product Characteristics
ColorORANGEScoreno score
ShapeCAPSULESize17mm
FlavorImprint Code44;546
Contains    
Packaging
#Item CodePackage Description
1NDC:59779-799-031 BLISTER PACK (1 BLISTER PACK) in 1 CARTON
110 CAPSULE, COATED (10 CAPSULE) in 1 BLISTER PACK
2NDC:59779-799-091 BLISTER PACK (1 BLISTER PACK) in 1 CARTON
220 CAPSULE, COATED (20 CAPSULE) in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34102/22/2007
Labeler - WOONSOCKET PRESCRIPTION CENTER,INCORPORATED (062312574)

 
WOONSOCKET PRESCRIPTION CENTER,INCORPORATED

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Further information

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

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