Non-Drying Sinus PE

Dosage form: capsule
Ingredients: GUAIFENESIN 200mg, PHENYLEPHRINE HYDROCHLORIDE 5mg
Labeler: WOONSOCKET PRESCRIPTION CENTER,INCORPORATED
NDC Code: 59779-548

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 44-548

Active ingredients (in each caplet)

Guaifenesin 200 mg
Phenylephrine HCl 5 mg

Purpose

Expectorant
Nasal decongestant

Uses
  • temporarily releives nasal congestion
  • promotes nasal and/or sinus drainage
  • temporarily relieves sinus congestion and pressure
  • help loosens phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Warnings

Do not use

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.

Ask a doctor before use if you have
  • 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, ashtma, chronic bronchitis, or emphysema

When using this product

do not exceed recommended dose.

Stop use and ask a doctor if
  • nervousness, dizziness, or sleeplessness
  • cough gets worse or lasts more than 7 days
  • symptoms do not improve within 7 days or occur with afever
  • cough tends to come back or occurs with fever, 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 overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions
  • 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 use

Other information
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number 

Inactive ingredients

corn starch, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silica gel, sodium starch glycolate, stearic acid, talc, titanium dioxide

Questions or comments?

1-800-426-9391

Principal display panel

CVS
pharmacy®

*Compare to the active ingredients in Sudafed PE® Sinus

Non-Drowsy
NON-DRYING
SINUS PE
MAXIMUM STRENGTH     
Does not contain Pseudoephedrine

GUAIFENESIN, PHENYLEPHRINE HCl
EXPECTORANT, NASAL DECONGESTANT

  • Nasal & sinus congestion
  • Sinus pressure
  • Sinus drainage

24 Coated Caplets

12 Doses
2 Pills Per Dose

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2013 CVS/pharmacy
www.cvs.com    1-800-shop-CVS

V-19849

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Sudafed® PE Non-Drying Sinus.
50844    REV0812C54808

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

CVS 44-548

NON-DRYING SINUS PE 
guaifenesin, phenylephrine hcl capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-548
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN200 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 
D&C YELLOW NO. 10 
MAGNESIUM STEARATE 
MALTODEXTRIN 
POLYVINYL ALCOHOL 
Product Characteristics
ColorBLUEScoreno score
ShapeCAPSULE (capsule shaped tablet) Size16mm
FlavorImprint Code44;548
Contains    
Packaging
#Item CodePackage Description
1NDC:59779-548-082 BLISTER PACK (2 BLISTER PACK) in 1 CARTON
112 CAPSULE (12 CAPSULE) in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34109/17/2003
Labeler - WOONSOCKET PRESCRIPTION CENTER,INCORPORATED (062312574)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(59779-548)

Revised: 02/2013
 
WOONSOCKET PRESCRIPTION CENTER,INCORPORATED

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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