Sinus Pain And Congestion

Sinus Pain And Congestion
SPL v17
SPL
SPL Set ID 697dffdd-5b56-4395-8e69-6b4360d9fdc5
Route
ORAL
Published
Effective Date 2025-12-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg) Phenylephrine (5 mg) Chlorpheniramine (2 mg)
Inactive Ingredients
Starch, Corn Crospovidone, Unspecified D&c Yellow No. 10 Aluminum Lake Fd&c Blue No. 1 Aluminum Lake Fd&c Red No. 40 Aluminum Lake Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol, Unspecified Polyvinyl Alcohol, Unspecified Povidone, Unspecified Silicon Dioxide Sodium Starch Glycolate Type A Potato Stearic Acid Sucralose Talc Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: 44;455 Shape: oval Color: green Color: white Size: 17 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2005-07-26

Description

Acetaminophen 325 mg Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer Nasal decongestant


Medication Information

Purpose

Pain reliever/fever reducer

Nasal decongestant

Description

Acetaminophen 325 mg Phenylephrine HCl 5 mg

Uses
  • temporarily relieves these symptoms associated with hay fever or other respiratory allergies, and the common cold:

    • nasal congestion
    • headache
    • minor aches and pains
    • sinus congestion and pressure
    • runny nose and sneezing  (Nighttime only)
  • promotes sinus drainage
  • helps clear nasal passages 
  • helps decongest sinus openings and passages
  • temporarily reduces fever



Warnings

Liver warning: This product contains acetaminophen. 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

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.

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
Do Not Use
  • if you have ever had an allergic reaction to this product or any of its ingredients
  • 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.

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
Questions Or Comments?

1-800-426-9391

Principal Display Panel

♥︎CVS

NDC 59779-779-08

actual size

Non-Drowsy

DAYTIME

SINUS PAIN &

CONGESTION

ACETAMINOPHEN

Pain Reliever, Fever Reducer

Phenylephrine HCl, Nasal Decongestant

Relieves: Headache, Sinus pressure

& Nasal congestion

12 CAPLETS

actual size

NIGHTTIME

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 CAPLETS

24 TOTAL CAPLETS

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

© 2025 CVS/pharmacy

CVS.com®

1-800-SHOP CVS

V-19849

100% money back 

guaranteed.

CVS.com/returnpolicy

50844 ORG072145546608

Do not take the

Daytime and Nighttime

caplets at the same time.

CVS 44-455C466
When Using This Product
  • do not exceed recommended dosage
  • use caution when driving a motor vehicle or operating machinery (Nighttime only)
  • drowsiness may occur  (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
  • 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.

In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. 

Read each section carefully. Do not take DAYTIME and NIGHTTIME products at the same time.

Active Ingredients (in Each Caplet)

Acetaminophen 325 mg

Phenylephrine HCl 5 mg

Ask A Doctor Before Use If You Have
  • heart disease
  • high blood pressure
  • liver disease
  • thyroid disease
  • diabetes
  • difficulty in urination due to enlargement of the prostate gland
  • a breathing problem such as emphysema or chronic bronchitis (Nighttime only)
  • glaucoma (Nighttime only)
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, silicon dioxide, 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, silicon dioxide, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide

Ask A Doctor Or Pharmacist Before Use If You Are
  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers (Nighttime only)

Structured Label Content

Uses
  • temporarily relieves these symptoms associated with hay fever or other respiratory allergies, and the common cold:

    • nasal congestion
    • headache
    • minor aches and pains
    • sinus congestion and pressure
    • runny nose and sneezing  (Nighttime only)
  • promotes sinus drainage
  • helps clear nasal passages 
  • helps decongest sinus openings and passages
  • temporarily reduces fever



Purpose

Pain reliever/fever reducer

Nasal decongestant

Warnings

Liver warning: This product contains acetaminophen. 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

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.

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
Do Not Use (Do not use)
  • if you have ever had an allergic reaction to this product or any of its ingredients
  • 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.

Other Information (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
Questions Or Comments? (Questions or comments?)

1-800-426-9391

Principal Display Panel

♥︎CVS

NDC 59779-779-08

actual size

Non-Drowsy

DAYTIME

SINUS PAIN &

CONGESTION

ACETAMINOPHEN

Pain Reliever, Fever Reducer

Phenylephrine HCl, Nasal Decongestant

Relieves: Headache, Sinus pressure

& Nasal congestion

12 CAPLETS

actual size

NIGHTTIME

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 CAPLETS

24 TOTAL CAPLETS

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

© 2025 CVS/pharmacy

CVS.com®

1-800-SHOP CVS

V-19849

100% money back 

guaranteed.

CVS.com/returnpolicy

50844 ORG072145546608

Do not take the

Daytime and Nighttime

caplets at the same time.

CVS 44-455C466
When Using This Product (When using this product)
  • do not exceed recommended dosage
  • use caution when driving a motor vehicle or operating machinery (Nighttime only)
  • drowsiness may occur  (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 (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, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. 

Read each section carefully. Do not take DAYTIME and NIGHTTIME products at the same time.

Active Ingredients (in Each Caplet) (Active ingredients (in each caplet))

Acetaminophen 325 mg

Phenylephrine HCl 5 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • heart disease
  • high blood pressure
  • liver disease
  • thyroid disease
  • diabetes
  • difficulty in urination due to enlargement of the prostate gland
  • a breathing problem such as emphysema or chronic bronchitis (Nighttime only)
  • glaucoma (Nighttime only)
Inactive Ingredients (daytime Only) (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, silicon dioxide, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide

Inactive Ingredients (nighttime Only) (Inactive ingredients (Nighttime only))

corn starch, crospovidone, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)
  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers (Nighttime only)

Advanced Ingredient Data


Raw Label Data

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