cvs 44-004063

cvs 44-004063
SPL v5
SPL
SPL Set ID 92c570ff-139f-49ff-a7bd-8a540ecc07c7
Route
oral
Published
Effective Date 2025-10-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
dextromethorphan (20 mg) guaifenesin (400 mg) phenylephrine (10 mg) acetaminophen (650 mg) triprolidine (2.5 mg)
Inactive Ingredients
anhydrous citric acid fd&c blue no. 1 fd&c red no. 40 glycerin propylene glycol water sodium benzoate trisodium citrate dihydrate sodium metabisulfite sorbitol sucralose xanthan gum fd&c yellow no. 6

Identifiers & Packaging

Pill Appearance
Color: blue
Marketing Status
otc monograph drug active Since 2022-05-27
Purpose

Cough suppressant Expectorant Nasal decongestant

Description

Dextromethorphan HBr 20 mg Guaifenesin 400 mg Phenylephrine HCl 10 mg

Medication Information

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:

  • rash

  • blisters

  • skin reddening

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

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Uses
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
  • temporarily relieves:
    • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
    • the intensity of coughing
    • the impulse to cough to help you get to sleep
    • nasal congestion due to a cold
Purpose

Cough suppressant

Expectorant

Nasal decongestant

Directions
  • do not take more than directed
  • do not take more than 6 doses in any 24-hour period
  • mL = milliliter
  • only use the dose cup provided
  • adults and children 12 years and over: 20 mL in dosing cup provided every 4 hours
  • children under 12 years: do not use
Other Information
  • each 20 mL contains: sodium 9 mg
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • use by expiration date on package
Inactive Ingredients

anhydrous citric acid, FD&C blue #1, FD&C red #40, flavors, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sodium metabisulfite, sorbitol, sucralose, xanthan gum

Description

Dextromethorphan HBr 20 mg Guaifenesin 400 mg Phenylephrine HCl 10 mg

Principal Display Panel

♥CVS

Health®

Compare to the

active ingredients in

Mucinex® FAST-MAX®

Severe Congestion & Cough*

MAXIMUM STRENGTH

Severe Congestion

& Cough Relief

DEXTROMETHORPHAN HBr -

Cough suppressant

GUAIFENESIN - Expectorant

PHENYLEPHRINE HCl -

Nasal decongestant

Multi-Symptom

• Controls cough

• Relieves nasal &

  chest congestion

• Thins & loosens mucus

For Ages 12 & Over

Mixed Berry

Flavor

♥CVS

Health®

Compare to the

active ingredients in

Mucinex® NIGHTSHIFT®

Cold & Flu*

Nighttime

Cold & Flu Relief

ACETAMINOPHEN -

Pain reliever/Fever reducer

DEXTROMETHORPHAN HBr -

Cough suppressant

TRIPROLIDINE HCl -

Antihistamine

Multi-Symptom

• Relieves cough

  & sore throat

• Reduces fever

• Relieves runny

  nose & sneezing

For Ages 12 & Over

Mixed Fruit

Flavor

TWO - 6 FL OZ (177 mL) BOTTLES / TOTAL 12 FL OZ (355 mL)

TAMPER EVIDENT: DO NOT USE IF IMPRINTED

SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

PARENTS:

Learn about teen medicine abuse

www.StopMedicineAbuse.org

Do not take Severe Congestion & Cough Relief

and Cold & Flu Relief at the same time.

Distributed by:

CVS Pharmacy, Inc.

One CVS Drive

Woonsocket, RI 02895

© 2023 CVS/pharmacy

CVS.com® 1-800-SHOP CVS V-19849

*This product is not manufactured or

distributed by RB Health (US) LLC, owner

of the registered trademark Mucinex®

FAST-MAX® Severe Congestion & Cough

and Mucinex® NIGHTSHIFT® Cold & Flu.

50844      REV0423A00406345

CVS_44-004063_REV0423A
Do Not Use
  • 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.
Questions Or Comments?

1-800-426-9391

When Using This Product

do not exceed recommended dosage.

Stop Use and Ask A Doctor If
  • nervousness, dizziness, or sleeplessness occur

  • symptoms do not get better within 7 days or occur with fever

  • cough persists more than 7 days, tends to recur, or is accompanied by a fever, rash, or persistent headache. 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.

Active Ingredients (in Each 20 Ml)

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Phenylephrine HCl 10 mg

Ask A Doctor Before Use If You Have
  • heart disease
  • diabetes
  • high blood pressure
  • difficulty in urination due to enlargement of the prostate gland
  • thyroid disease
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • cough that occurs with too much phlegm (mucus)
Ask A Doctor Or Pharmacist Before Use If You Are
  • taking sedatives or tranquilizers

  • taking the blood thinning drug warfarin

Structured Label Content

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:

  • rash

  • blisters

  • skin reddening

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

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Uses
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
  • temporarily relieves:
    • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
    • the intensity of coughing
    • the impulse to cough to help you get to sleep
    • nasal congestion due to a cold
Purpose

Cough suppressant

Expectorant

Nasal decongestant

Directions
  • do not take more than directed
  • do not take more than 6 doses in any 24-hour period
  • mL = milliliter
  • only use the dose cup provided
  • adults and children 12 years and over: 20 mL in dosing cup provided every 4 hours
  • children under 12 years: do not use
Other Information (Other information)
  • each 20 mL contains: sodium 9 mg
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • use by expiration date on package
Inactive Ingredients (Inactive ingredients)

anhydrous citric acid, FD&C blue #1, FD&C red #40, flavors, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sodium metabisulfite, sorbitol, sucralose, xanthan gum

Principal Display Panel (Principal display panel)

♥CVS

Health®

Compare to the

active ingredients in

Mucinex® FAST-MAX®

Severe Congestion & Cough*

MAXIMUM STRENGTH

Severe Congestion

& Cough Relief

DEXTROMETHORPHAN HBr -

Cough suppressant

GUAIFENESIN - Expectorant

PHENYLEPHRINE HCl -

Nasal decongestant

Multi-Symptom

• Controls cough

• Relieves nasal &

  chest congestion

• Thins & loosens mucus

For Ages 12 & Over

Mixed Berry

Flavor

♥CVS

Health®

Compare to the

active ingredients in

Mucinex® NIGHTSHIFT®

Cold & Flu*

Nighttime

Cold & Flu Relief

ACETAMINOPHEN -

Pain reliever/Fever reducer

DEXTROMETHORPHAN HBr -

Cough suppressant

TRIPROLIDINE HCl -

Antihistamine

Multi-Symptom

• Relieves cough

  & sore throat

• Reduces fever

• Relieves runny

  nose & sneezing

For Ages 12 & Over

Mixed Fruit

Flavor

TWO - 6 FL OZ (177 mL) BOTTLES / TOTAL 12 FL OZ (355 mL)

TAMPER EVIDENT: DO NOT USE IF IMPRINTED

SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

PARENTS:

Learn about teen medicine abuse

www.StopMedicineAbuse.org

Do not take Severe Congestion & Cough Relief

and Cold & Flu Relief at the same time.

Distributed by:

CVS Pharmacy, Inc.

One CVS Drive

Woonsocket, RI 02895

© 2023 CVS/pharmacy

CVS.com® 1-800-SHOP CVS V-19849

*This product is not manufactured or

distributed by RB Health (US) LLC, owner

of the registered trademark Mucinex®

FAST-MAX® Severe Congestion & Cough

and Mucinex® NIGHTSHIFT® Cold & Flu.

50844      REV0423A00406345

CVS_44-004063_REV0423A
Do Not Use (Do not use)
  • 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.
Questions Or Comments? (Questions or comments?)

1-800-426-9391

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

  • symptoms do not get better within 7 days or occur with fever

  • cough persists more than 7 days, tends to recur, or is accompanied by a fever, rash, or persistent headache. 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 overdose, get medical help or contact a Poison Control Center right away.

Active Ingredients (in Each 20 Ml) (Active ingredients (in each 20 mL))

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Phenylephrine HCl 10 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • heart disease
  • diabetes
  • high blood pressure
  • difficulty in urination due to enlargement of the prostate gland
  • thyroid disease
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • cough that occurs with too much phlegm (mucus)
Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)
  • taking sedatives or tranquilizers

  • taking the blood thinning drug warfarin

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:03:49.688110 · Updated: 2026-03-14T23:13:06.603726