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SINUS PAIN AND CONGESTION by CVS Pharmacy

Dosage form: kit
Ingredients: ACETAMINOPHEN 325mg, PHENYLEPHRINE HYDROCHLORIDE 5mg; ACETAMINOPHEN 325mg, CHLORPHENIRAMINE MALEATE 2mg, PHENYLEPHRINE HYDROCHLORIDE 5mg
Labeler: CVS Pharmacy
NDC Code: 59779-779

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 44-455C466

Active ingredients (in each caplet)
(Daytime Sinus Congestion & Pain) 

Acetaminophen 325 mg
Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer
Nasal decongestant

Active ingredients (in each caplet)
(Nighttime Sinus Congestion & Pain)

Acetaminophen 325 mg
Chlorpheniramine maleate 2 mg
Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer
Antihistamine
Nasal decongestant

Uses
  • temporarily relieves these symptoms associated with hay fever or other respiratory allergies, and the common cold:
    • minor aches and pains
    • headache
    • nasal congestion
    • sinus congestion and pressure
    • runny nose and sneezing(Nighttime only)
  • helps decongest sinus openings and passages
  • promotes sinus drainage
  • temporarily reduces fever
  • helps clear nasal passages

Warnings

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

  • more than 4,000 mg 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

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

  • skin reddening 
  • blisters
  • rash

If a skin reaction occurs, stop use and seek medical help right away.

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
  • heart disease
  • high blood pressure
  • diabetes
  • thyroid disease
  • difficulty in urination due to enlargement of the prostate gland
  • liver disease
  • a breathing problem such as emphysema or chronic bronchitis (Nighttime only)
  • glaucoma (Nighttime only)

Ask a doctor or pharmacist before use if you are
  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers (Nighttime only)

When using this product
  • do not exceed recommended dosage
  • use caution when driving a motor vehicle or operating machinery (Nighttime only)
  • may cause drowsiness (Nighttime only)
  • excitability may occur, especially in children (Nighttime only)
  • alcohol, sedatives, and tranquilizers may increase drowsiness (Nighttime only)
  • avoid alcoholic beverages (Nighttime only)

Stop use and ask a doctor if
  • nervousness, dizziness, or sleeplessness occur
  • pain or nasal congestion gets worse or lasts more than 7 days
  • new symptoms occur
  • redness or swelling is present
  • fever gets worse or lasts more than 3 days

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 accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. 

If taking NIGHTTIME and DAYTIME products, carefully read each section to ensure correct dosing.

Directions
  • do not take more than directed 
  • 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 (Daytime only)

corn starch, crospovidone, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silica gel, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide

Inactive ingredients(Nighttime only)

corn starch, crospovidone, flavor, magnesium stearate, 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

Sinus

DAYTIME -  Non Drowsy

Sinus Pain & Congestion

ACETAMINOPHEN
Pain reliever, Fever reducer
PHENYLEPHRINE HCl
Nasal decongestant

Relieves:
Headache, Sinus pressure
& Nasal congestion

12 COOL CAPLETS
With cool blast flavor

Actual Size

NIGHTTIME - To Let You Sleep

Sinus Pain & Congestion

ACETAMINOPHEN
Pain reliever, Fever reducer
CHLORPHENIRAMINE MALEATE
Antihistamine
PHENYLEPHRINE HCl
Nasal decongestant

Relieves:
Fever, Headache, Sinus pressure,
Nasal congestion & Runny nose

12 COOL CAPLETS
With cool blast flavor

Actual Size

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
© 2016 CVS/pharmacy     CVS.com®     1-800-SHOP CVS    

V-19849

CVS®Quality
Money Back Guarantee

50844 REV0716A45546608

Do not take the Daytime and Nighttime caplets at the same time.

CVS Health 44-455C466

SINUS PAIN AND CONGESTION 
acetaminophen, chlorpheniramine maleate, phenylephrine hcl kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-779
Packaging
#Item CodePackage Description
1NDC:59779-779-081 KIT in 1 PACKAGE, COMBINATION
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BLISTER PACK 12 
Part 21 BLISTER PACK 12 
Part 1 of 2
SINUS PAIN AND CONGESTION 
acetaminophen, phenylephrine hcl tablet, film coated
Product Information
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
STARCH, CORN 
CROSPOVIDONE 
D&C YELLOW NO. 10 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOLS 
POVIDONE 
STEARIC ACID 
SUCRALOSE 
TALC 
TITANIUM DIOXIDE 
Product Characteristics
ColorGREENScoreno score
ShapeOVALSize17mm
FlavorMENTHOLImprint Code44;466
Contains    
Packaging
#Item CodePackage Description
112 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34107/26/2005
Part 2 of 2
SINUS PAIN AND CONGESTION 
acetaminophen, chlorpheniramine maleate, phenylephrine hcl tablet, film coated
Product Information
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
CHLORPHENIRAMINE MALEATE (CHLORPHENIRAMINE) CHLORPHENIRAMINE MALEATE2 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN 
CROSPOVIDONE 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOLS 
POVIDONE 
STEARIC ACID 
SUCRALOSE 
TALC 
TITANIUM DIOXIDE 
Product Characteristics
ColorWHITEScoreno score
ShapeOVALSize17mm
FlavorMENTHOLImprint Code44;455
Contains    
Packaging
#Item CodePackage Description
112 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34106/28/2005
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34107/26/2005
Labeler - CVS Pharmacy (062312574)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(59779-779)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867894MANUFACTURE(59779-779)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.967626305PACK(59779-779)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.868734088PACK(59779-779)

 
CVS Pharmacy

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Medically reviewed on Nov 29, 2016

Further information

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

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