cvs 44-648

cvs 44-648
SPL v16
SPL
SPL Set ID 707eb066-cdfc-444b-833a-9d6d133d48e4
Route
oral
Published
Effective Date 2025-07-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
dextromethorphan (10 mg) guaifenesin (200 mg) phenylephrine (5 mg)
Inactive Ingredients
starch, corn fd&c blue no. 2--aluminum lake fd&c red no. 40 magnesium stearate maltodextrin microcrystalline cellulose polyethylene glycol, unspecified polysorbate 80 polyvinyl alcohol, unspecified povidone, unspecified silicon dioxide sodium starch glycolate type a potato stearic acid talc titanium dioxide

Identifiers & Packaging

Pill Appearance
Imprint: 44;648 Shape: oval Color: red Size: 19 mm Score: 1
Marketing Status
otc monograph drug active Since 2015-07-20 Until 2023-07-19
Purpose

Cough suppressant Expectorant Nasal decongestant

Description

Dextromethorphan HBr 10 mg Guaifenesin 200 mg Phenylephrine HCl 5 mg

Medication Information

Uses
  • 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
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
Purpose

Cough suppressant

Expectorant

Nasal decongestant

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 
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 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number

Inactive Ingredients

corn starch, FD&C blue #2 aluminum lake, FD&C red #40 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polysorbate 80, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide

Description

Dextromethorphan HBr 10 mg Guaifenesin 200 mg Phenylephrine HCl 5 mg

Principal Display Panel

50% MORE TABLETS THAN THE

NATIONAL BRAND†

♥︎CVS

Health®

Compare to the active ingredients

in Maximum Strength Mucinex®

FAST-MAX® Severe Congestion & Cough*

Multi-Symptom

Severe Congestion

& Cough

DEXTROMETHORPHAN HBr 

Cough suppressant

GUAIFENESIN - Expectorant

PHENYLEPHRINE HCl 

Nasal decongestant

MAXIMUM STRENGTH

Relieves:

Nasal & chest congestion

Controls cough

Thins & loosens mucus

For Ages 12+

Actual Size

30 COATED 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® FAST-MAX®

Severe Congestion & Cough.

50844    REV0423D64801

†50% more tablets than Maximum Strength

Mucinex® FAST-MAX® Severe Congestion

& Cough 20 count package.

Distributed by:

CVS Pharmacy, Inc.

One CVS Drive

Woonsocket, RI 02895

© 2023 CVS/pharmacy

CVS.com®

1-800-SHOP CVS

V-19849

100% money back

guaranteed.

CVS.com/returnpolicy

PARENTS:

Learn about teen medicine abuse

www.StopMedicineAbuse.org

CVS 44-648
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 Caplet)

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

Ask A Doctor Before Use If You Have
  • heart disease
  • high blood pressure
  • 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) 

Structured Label Content

Uses
  • 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
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
Purpose

Cough suppressant

Expectorant

Nasal decongestant

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 
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 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number

Inactive Ingredients (Inactive ingredients)

corn starch, FD&C blue #2 aluminum lake, FD&C red #40 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polysorbate 80, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide

Principal Display Panel

50% MORE TABLETS THAN THE

NATIONAL BRAND†

♥︎CVS

Health®

Compare to the active ingredients

in Maximum Strength Mucinex®

FAST-MAX® Severe Congestion & Cough*

Multi-Symptom

Severe Congestion

& Cough

DEXTROMETHORPHAN HBr 

Cough suppressant

GUAIFENESIN - Expectorant

PHENYLEPHRINE HCl 

Nasal decongestant

MAXIMUM STRENGTH

Relieves:

Nasal & chest congestion

Controls cough

Thins & loosens mucus

For Ages 12+

Actual Size

30 COATED 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® FAST-MAX®

Severe Congestion & Cough.

50844    REV0423D64801

†50% more tablets than Maximum Strength

Mucinex® FAST-MAX® Severe Congestion

& Cough 20 count package.

Distributed by:

CVS Pharmacy, Inc.

One CVS Drive

Woonsocket, RI 02895

© 2023 CVS/pharmacy

CVS.com®

1-800-SHOP CVS

V-19849

100% money back

guaranteed.

CVS.com/returnpolicy

PARENTS:

Learn about teen medicine abuse

www.StopMedicineAbuse.org

CVS 44-648
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 Caplet) (Active ingredients (in each caplet))

Dextromethorphan HBr 10 mg

Guaifenesin 200 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
  • 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) 

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:35.825358 · Updated: 2026-03-14T23:09:28.158875