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
Description

Dextromethorphan HBr 20 mg Guaifenesin 400 mg Phenylephrine HCl 10 mg

Purpose

Cough suppressant Expectorant Nasal decongestant

Medication Information

Purpose

Cough suppressant

Expectorant

Nasal decongestant

Description

Dextromethorphan HBr 20 mg Guaifenesin 400 mg Phenylephrine HCl 10 mg

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
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.

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
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.
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

Questions Or Comments?

1-800-426-9391

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
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

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

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.

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
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.
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

Questions Or Comments? (Questions or comments?)

1-800-426-9391

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
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

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