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SINUS PAIN AND CONGESTION DAYTIME

Dosage form: tablet
Ingredients: ACETAMINOPHEN 325mg, PHENYLEPHRINE HYDROCHLORIDE 5mg
Labeler: CVS Pharmacy
NDC Code: 59779-558

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 44-558-Delisting

Active ingredients (in each gelcap)

Acetaminophen 325 mg
Phenylephrine HCl 5 mg

Purpose

Pain reliever
Nasal decongestant

Uses
  • for the temporary relief of:
    • minor aches and pain
    • headache
    • nasal congestion
    • sinus congestion and pressure
  • helps decongest sinus openings and passages
  • promotes sinus drainage
  • helps clear nasal passages

Warnings

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

  • more than 12 gelcaps 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

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. 

Ask a doctor before use if you have
  • liver disease
  • diabetes
  • heart disease
  • high blood pressure
  • thyroid disease
  • trouble urinating due to an enlarged prostate gland 

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 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

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 gelcaps every 4 hours
    • do not take more than 12 gelcaps in 24 hours
  • children under 12 years: do not use 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 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number 

Inactive ingredients

croscarmellose sodium, crospovidone, D&C yellow #10, FD&C blue #1, FD&C red #40, FD&C yellow #6, gelatin, hydroxypropyl cellulose, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, shellac glaze, silica gel, stearic acid, titanium dioxide

Questions or comments?

1-800-426-9391

Principal Display Panel

CVS
pharmacy™

NON-DROWSY

SINUS PAIN &
CONGESTION
DAYTIME

Acetaminophen - Pain reliever
Phenylephrine HCl - Nasal decongestant

Headache, Sinus pressure, Nasal congestion

24 RAPID RELEASE GELCAPS

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

50844    ORG071255808

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

CVS 44-558

SINUS PAIN AND CONGESTION DAYTIME 
acetaminophen and phenylephrine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-558
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM 
D&C YELLOW NO. 10 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
HYDROXYPROPYL CELLULOSE, UNSPECIFIED 
HYPROMELLOSES 
MAGNESIUM STEARATE 
POLYETHYLENE GLYCOLS 
STEARIC ACID 
TITANIUM DIOXIDE 
FD&C YELLOW NO. 6 
GELATIN, UNSPECIFIED 
FERROSOFERRIC OXIDE 
FERRIC OXIDE RED 
FERRIC OXIDE YELLOW 
CELLULOSE, MICROCRYSTALLINE 
POVIDONES 
PROPYLENE GLYCOL 
SILICON DIOXIDE 
Product Characteristics
ColorRED, GREENScoreno score
ShapeOVALSize19mm
FlavorImprint CodeL;8
Contains    
Packaging
#Item CodePackage Description
1NDC:59779-558-082 BLISTER PACK in 1 CARTON
112 TABLET in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34103/17/200807/08/2019
Labeler - CVS Pharmacy (062312574)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(59779-558)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867894MANUFACTURE(59779-558)

 
CVS Pharmacy

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Medically reviewed on Jul 26, 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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