Cvs 44-615-sm

SPL v3

SPL

SPL Set ID c70e6506-6c5b-4d3f-ab18-a690840caabc

Route

ORAL

Published

Effective Date 2025-04-26

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (325 mg) Guaifenesin (200 mg) Phenylephrine (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

Identifiers & Packaging

Pill Appearance

Imprint: 44;615 Shape: oval Color: orange Size: 19 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2024-04-03

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:
- nasal congestion
- headache
- minor aches and pains
- sinus congestion and pressure
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

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.
if you have ever had an allergic reaction to this product or any of its ingredients

Other Information

each caplet contains: sodium 3 mg
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

Inactive Ingredients

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

Questions Or Comments?

1-800-426-9391

Principal Display Panel

♥CVS

Health_®

Compare to the active ingredients in

Maximum Strength Mucinex®

Sinus-Max® Severe Congestion & Pain*

NDC 51316-516-09

MAXIMUM STRENGTH

Mucus Relief

Sinus Severe

Congestion & Pain

ACETAMINOPHEN - Pain reliever

GUAIFENESIN - Expectorant

PHENYLEPHRINE HCl - Nasal decongestant

Relieves:

• Sinus congestion

• Headache

Thins & loosens mucus

Ages 12 Years & Over

Actual Size

20 CAPLETS

TAMPER EVIDENT: DO NOT USE IF

PACKAGE IS OPENED OR IF BLISTER

UNIT IS TORN, BROKEN OR SHOWS

ANY SIGNS OF TAMPERING

*This product is not manufactured or distributed by RB Health (US) LLC, owner of the

registered trademark Maximum Strength Mucinex® Sinus-Max® Severe Congestion & Pain.

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

© 2024 CVS/pharmacy

CVS.com® 1-800-SHOP CVS V-19849

100% money back

guaranteed.

CVS.com/returnpolicy

50844

ORG062361509

CVS 44-615

When Using This Product

do not exceed recommended dosage.

Stop Use and Ask A Doctor If

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

Ask A Doctor Before Use If You Have

liver disease
thyroid disease
diabetes
heart disease
difficulty in urination due to enlargement of the prostate gland
persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
high blood pressure
cough that occurs with too much phlegm (mucus)

Active Ingredients (in Each Caplet)

Acetaminophen 325 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

Ask A Doctor Or Pharmacist Before Use If You Are

taking the blood thinning drug warfarin.

Structured Label Content

Uses

temporarily relieves:
- nasal congestion
- headache
- minor aches and pains
- sinus congestion and pressure
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

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.
if you have ever had an allergic reaction to this product or any of its ingredients

Other Information (Other information)

each caplet contains: sodium 3 mg
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

Inactive Ingredients (Inactive ingredients)

Questions Or Comments? (Questions or comments?)

1-800-426-9391

Principal Display Panel (Principal display panel)

♥CVS

Health_®

Compare to the active ingredients in

Maximum Strength Mucinex®

Sinus-Max® Severe Congestion & Pain*

NDC 51316-516-09

MAXIMUM STRENGTH

Mucus Relief

Sinus Severe

Congestion & Pain

ACETAMINOPHEN - Pain reliever

GUAIFENESIN - Expectorant

PHENYLEPHRINE HCl - Nasal decongestant

Relieves:

• Sinus congestion

• Headache

Thins & loosens mucus

Ages 12 Years & Over

Actual Size

20 CAPLETS

TAMPER EVIDENT: DO NOT USE IF

PACKAGE IS OPENED OR IF BLISTER

UNIT IS TORN, BROKEN OR SHOWS

ANY SIGNS OF TAMPERING

*This product is not manufactured or distributed by RB Health (US) LLC, owner of the

registered trademark Maximum Strength Mucinex® Sinus-Max® Severe Congestion & Pain.

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

© 2024 CVS/pharmacy

CVS.com® 1-800-SHOP CVS V-19849

100% money back

guaranteed.

CVS.com/returnpolicy

50844

ORG062361509

CVS 44-615

When Using This Product (When using this product)

do not exceed recommended dosage.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

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

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

liver disease
thyroid disease
diabetes
heart disease
difficulty in urination due to enlargement of the prostate gland
persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
high blood pressure
cough that occurs with too much phlegm (mucus)

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

Acetaminophen 325 mg

Guaifenesin 200 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.

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "temporarily relieves: nasal congestion headache minor aches and pains sinus congestion and pressure 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", "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. if you have ever had an allergic reaction to this product or any of its ingredients", "Other information": "each caplet contains: sodium 3 mg 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", "Inactive ingredients": "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", "Questions or comments?": "1-800-426-9391", "Principal display panel": "♥ CVS Health ® Compare to the active ingredients in Maximum Strength Mucinex® Sinus-Max® Severe Congestion & Pain* NDC 51316-516-09 MAXIMUM STRENGTH Mucus Relief Sinus Severe Congestion & Pain ACETAMINOPHEN - Pain reliever GUAIFENESIN - Expectorant PHENYLEPHRINE HCl - Nasal decongestant Relieves: • Sinus congestion • Headache Thins & loosens mucus Ages 12 Years & Over Actual Size 20 CAPLETS TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING *This product is not manufactured or distributed by RB Health (US) LLC, owner of the registered trademark Maximum Strength Mucinex® Sinus-Max® Severe Congestion & Pain. Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895 © 2024 CVS/pharmacy CVS.com® 1-800-SHOP CVS V-19849 100% money back guaranteed. CVS.com/returnpolicy 50844 ORG062361509 CVS 44-615", "When using this product": "do not exceed recommended dosage.", "Stop use and ask a doctor if": "nervousness, dizziness, or sleeplessness occur fever gets worse or lasts more than 3 days pain, nasal congestion, or cough gets worse or lasts more than 7 days redness or swelling is present new symptoms occur 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.", "Ask a doctor before use if you have": "liver disease thyroid disease diabetes heart disease difficulty in urination due to enlargement of the prostate gland persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema high blood pressure cough that occurs with too much phlegm (mucus)", "Active ingredients (in each caplet)": "Acetaminophen 325 mg Guaifenesin 200 mg Phenylephrine HCl 5 mg", "Ask a doctor or pharmacist before use if you are": "taking the blood thinning drug warfarin."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:59.950995 · Updated: 2026-03-14T23:08:27.251685