Cvs 44-615694-09

SPL v14

SPL

SPL Set ID f6b3ca40-7638-477f-b800-4c28c40ff0a8

Route

ORAL

Published

Effective Date 2025-12-11

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (325 mg) Guaifenesin (200 mg) Phenylephrine (5 mg) Diphenhydramine (12.5 mg)

Inactive Ingredients

Starch, Corn Crospovidone, Unspecified Fd&c Red No. 40 Aluminum Lake Fd&c Yellow No. 6 Aluminum Lake Magnesium Stearate Maltodextrin Microcrystalline Cellulose Polyethylene Glycol, Unspecified Polyvinyl Alcohol, Unspecified Povidone, Unspecified Silicon Dioxide Sodium Starch Glycolate Type A Potato Stearic Acid Talc Titanium Dioxide Croscarmellose Sodium Fd&c Blue No. 1 Aluminum Lake Fd&c Blue No. 2 Aluminum Lake Ferric Oxide Yellow Methacrylic Acid And Ethyl Acrylate Copolymer Sodium Bicarbonate

Identifiers & Packaging

Pill Appearance

Imprint: 44;694 Shape: oval Color: orange Color: blue Size: 19 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2017-07-01

Description

Acetaminophen 325 mg Guaifenesin 200 mg Phenylephrine HCl 5 mg

Purpose

Pain reliever Expectorant Nasal decongestant

Medication Information

Purpose

Pain reliever

Expectorant

Nasal decongestant

Description

Acetaminophen 325 mg Guaifenesin 200 mg Phenylephrine HCl 5 mg

Uses

temporarily relieves these common cold symptoms:
nasal congestion
headache
minor aches and pains
sinus congestion and pressure
cough (nighttime only)
runny nose and sneezing (nighttime only)
temporarily promotes nasal and/or sinus drainage
helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive (daytime only)

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
do not take more than 12 caplets in any 24-hour period
adults and children 12 years and over: take 2 caplets every 4 hours
children under 12 years: do not use

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.
with any other product containing diphenhydramine, even one used on skin (nighttime only)

Other Information

each caplet contains: sodium 3 mg (daytime only)
TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
see end flap for expiration date and lot number

Questions Or Comments?

1-800-426-9391

Principal Display Panel

♥︎CVS _™

NDC 69842-882-09

Maximum Strength

Daytime

Sinus Relief

ACETAMINOPHEN, Pain reliever

GUAIFENESIN, Expectorant

PHENYLEPHRINE HCl, Nasal decongestant

Relieves: Sinus pressure & congestion,

Headache | Thins & Loosens Mucus

10 DAY

CAPLETS

actual

size

Maximum Strength

Nighttime

Sinus Relief

ACETAMINOPHEN, Pain reliever

DIPHENHYDRAMINE HCl

Antihistamine, Cough suppressant

PHENYLEPHRINE HCl, Nasal decongestant

Relieves: Nasal congestion, Sinus pressure

& pain, Runny nose, Sneezing, Cough

10 NIGHT

CAPLETS

actual

size

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER

UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

Do Not Take Daytime and

Nighttime Products at the

Same Time.

50844 ORG082461569409

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

CVS 44-615694

When Using This Product

do not exceed recommended dosage
excitability may occur, especially in children (nighttime only)
marked drowsiness may occur (nighttime only)
alcohol, sedatives, and tranquilizers may increase drowsiness (nighttime only)
use caution when driving a motor vehicle or operating machinery (nighttime only)
avoid alcoholic beverages (nighttime only)

Stop Use and Ask A Doctor If

nervousness, dizziness, or sleeplessness occur
pain, nasal congestion, or cough gets worse or lasts more than 7 days
new symptoms occur
fever gets worse or lasts more than 3 days
redness or swelling is present
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.

In case of 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.

Do not take DAYTIME and NIGHTTIME products at the same time.

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
persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
cough that occurs with too much phlegm (mucus)
a breathing problem such as emphysema or chronic bronchitis (nighttime only)
glaucoma (nighttime only)

Inactive Ingredients (daytime Only)

corn starch, crospovidone, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide

Inactive Ingredients (nighttime Only)

corn starch, croscarmellose sodium, crospovidone, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, iron oxide yellow, magnesium stearate, methacrylic acid and ethyl acrylate copolymer, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium bicarbonate, stearic acid, talc, titanium dioxide

Active Ingredients (in Each Caplet) (daytime)

Acetaminophen 325 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

Active Ingredients (in Each Caplet) (nighttime)

Acetaminophen 325 mg

Diphenhydramine HCl 12.5 mg

Phenylephrine HCl 5 mg

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 common cold symptoms:
nasal congestion
headache
minor aches and pains
sinus congestion and pressure
cough (nighttime only)
runny nose and sneezing (nighttime only)
temporarily promotes nasal and/or sinus drainage
helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive (daytime only)

Purpose

Pain reliever

Expectorant

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
do not take more than 12 caplets in any 24-hour period
adults and children 12 years and over: take 2 caplets every 4 hours
children under 12 years: do not use

Do Not Use (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.
with any other product containing diphenhydramine, even one used on skin (nighttime only)

Other Information (Other information)

each caplet contains: sodium 3 mg (daytime only)
TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
see end flap for expiration date and lot number

Questions Or Comments? (Questions or comments?)

1-800-426-9391

Principal Display Panel

♥︎CVS _™

NDC 69842-882-09

Maximum Strength

Daytime

Sinus Relief

ACETAMINOPHEN, Pain reliever

GUAIFENESIN, Expectorant

PHENYLEPHRINE HCl, Nasal decongestant

Relieves: Sinus pressure & congestion,

Headache | Thins & Loosens Mucus

10 DAY

CAPLETS

actual

size

Maximum Strength

Nighttime

Sinus Relief

ACETAMINOPHEN, Pain reliever

DIPHENHYDRAMINE HCl

Antihistamine, Cough suppressant

PHENYLEPHRINE HCl, Nasal decongestant

Relieves: Nasal congestion, Sinus pressure

& pain, Runny nose, Sneezing, Cough

10 NIGHT

CAPLETS

actual

size

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER

UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

Do Not Take Daytime and

Nighttime Products at the

Same Time.

50844 ORG082461569409

V-19849

100% money back

guaranteed.

CVS.com/returnpolicy

CVS 44-615694

When Using This Product (When using this product)

do not exceed recommended dosage
excitability may occur, especially in children (nighttime only)
marked drowsiness may occur (nighttime only)
alcohol, sedatives, and tranquilizers may increase drowsiness (nighttime only)
use caution when driving a motor vehicle or operating machinery (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, nasal congestion, or cough gets worse or lasts more than 7 days
new symptoms occur
fever gets worse or lasts more than 3 days
redness or swelling is present
cough comes back or occurs with rash or headache that lasts. 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.)

Do not take DAYTIME and NIGHTTIME products at the same time.

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
persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
cough that occurs with too much phlegm (mucus)
a breathing problem such as emphysema or chronic bronchitis (nighttime only)
glaucoma (nighttime only)

Inactive Ingredients (daytime Only) (Inactive ingredients (daytime only))

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

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

Acetaminophen 325 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

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

Acetaminophen 325 mg

Diphenhydramine HCl 12.5 mg

Phenylephrine HCl 5 mg

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

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Raw Label Data

All Sections (JSON)

{"Uses": "temporarily relieves these common cold symptoms: nasal congestion headache minor aches and pains sinus congestion and pressure cough (nighttime only) runny nose and sneezing (nighttime only) temporarily promotes nasal and/or sinus drainage helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive (daytime only)", "Purpose": "Pain reliever Expectorant 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 do not take more than 12 caplets in any 24-hour period adults and children 12 years and over: take 2 caplets every 4 hours children under 12 years: do not use", "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. with any other product containing diphenhydramine, even one used on skin (nighttime only)", "Other information": "each caplet contains: sodium 3 mg (daytime only) TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) see end flap for expiration date and lot number", "Questions or comments?": "1-800-426-9391", "Principal Display Panel": "♥︎ CVS ™ NDC 69842-882-09 Maximum Strength Daytime Sinus Relief ACETAMINOPHEN, Pain reliever GUAIFENESIN, Expectorant PHENYLEPHRINE HCl, Nasal decongestant Relieves: Sinus pressure & congestion, Headache | Thins & Loosens Mucus 10 DAY CAPLETS actual size Maximum Strength Nighttime Sinus Relief ACETAMINOPHEN , Pain reliever DIPHENHYDRAMINE HCl Antihistamine, Cough suppressant PHENYLEPHRINE HCl, Nasal decongestant Relieves: Nasal congestion, Sinus pressure & pain, Runny nose, Sneezing, Cough 10 NIGHT CAPLETS actual size TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING Do Not Take Daytime and Nighttime Products at the Same Time. 50844 ORG082461569409 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 CVS 44-615694", "When using this product": "do not exceed recommended dosage excitability may occur, especially in children (nighttime only) marked drowsiness may occur (nighttime only) alcohol, sedatives, and tranquilizers may increase drowsiness (nighttime only) use caution when driving a motor vehicle or operating machinery (nighttime only) avoid alcoholic beverages (nighttime only)", "Stop use and ask a doctor if": "nervousness, dizziness, or sleeplessness occur pain, nasal congestion, or cough gets worse or lasts more than 7 days new symptoms occur fever gets worse or lasts more than 3 days redness or swelling is present 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.": "In case of 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. Do not take DAYTIME and NIGHTTIME products at the same time.", "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 persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema cough that occurs with too much phlegm (mucus) a breathing problem such as emphysema or chronic bronchitis (nighttime only) glaucoma (nighttime only)", "Inactive ingredients (daytime only)": "corn starch, crospovidone, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide", "Inactive ingredients (nighttime only)": "corn starch, croscarmellose sodium, crospovidone, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, iron oxide yellow, magnesium stearate, methacrylic acid and ethyl acrylate copolymer, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium bicarbonate, stearic acid, talc, titanium dioxide", "Active ingredients (in each caplet) (daytime)": "Acetaminophen 325 mg Guaifenesin 200 mg Phenylephrine HCl 5 mg", "Active ingredients (in each caplet) (nighttime)": "Acetaminophen 325 mg Diphenhydramine HCl 12.5 mg Phenylephrine HCl 5 mg", "Ask a doctor or pharmacist before use if you are": "taking the blood thinning drug warfarin taking sedatives or tranquilizers (nighttime only)"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:37.806931 · Updated: 2026-03-14T23:11:19.831195