FDA.reportPublic FDA data

CVS Maximum Strength Severe Congestion and Cough Cooling Menthol Flavor

Manufacturer
CVS PHARMACY, INC
Effective date
2026-08-19
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
daily-update
Hydrated at
2026-08-21 02:02:02

Label at a glance#

ProductCVS Maximum Strength Severe Congestion and Cough
Active ingredientdextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride
Label structure8 sections

Indications and 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 • nasal congestion due to a cold • temporarily helps you cough less

Dosage and administration

• do not take more than 6 doses in any 24-hour period • measure only with dosing cup provided • do not use dosing cup with other products • dose as follows or as directed by a doctor • mL = milliliter • adults and children 12 years of age and older: 20 mL in dosing cup provided every 4 hours. • children under 12 years of age: Do not use.

Storage and handling

• each 20 mL contains: sodium 6 mg • very low sodium • store at room temperature • do not refrigerate • dosing cup provided anhydrous citric acid, D&C Yellow No. 10, edetate disodium, FD&C Blue No. 1, flavor, potassium citrate, propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients
(in each 20 mL)		Purposes

Dextromethorphan HBr 20 mg

Cough suppressant

Guaifenesin 400 mg

Expectorant

Phenylephrine HCl 10 mg

Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

  • 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
    • nasal congestion due to a cold
    • temporarily helps you cough less

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

  • 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.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
  • cough that occurs with too much phlegm (mucus)

When using this product do not use more than directed

OTC - WHEN USING SECTION

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • nervousness, dizziness or sleeplessness occur
  • symptoms do not get better within 7 days or occur with fever
  • cough comes back, or occurs with rash or headache that lasts. These could be signs of a serious condition.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away at (1-800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not take more than 6 doses in any 24-hour period
  • measure only with dosing cup provided
  • do not use dosing cup with other products
  • dose as follows or as directed by a doctor
  • mL = milliliter
  • adults and children 12 years of age and older: 20 mL in dosing cup provided every 4 hours.
  • children under 12 years of age: Do not use.

Other information

STORAGE AND HANDLING SECTION

  • each 20 mL contains: sodium 6 mg
  • very low sodium
  • store at room temperature
  • do not refrigerate
  • dosing cup provided

Inactive Ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, D&C Yellow No. 10, edetate disodium, FD&C Blue No. 1, flavor, potassium citrate, propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum.

Questions or comments?

OTC - QUESTIONS SECTION

1-866-467-2748

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC# 69842-767-06

Compare to Mucinex® Fast-Max® Maximum Strength Severe Congestion & Cough Clear and Cool® Active Ingredients*

Maximum Strength

Severe Congestion & Cough


  • Dextromethorphan HBr Cough Suppressant
    Guaifenesin Expectorant
    Phenylephrine HCl Nasal Decongestant
  1. Controls Cough,
  2. Relieves Nasal & Chest Congestion
  3. Thins & Loosens Mucus

Cooling Menthol Flavor

Naturally and Artificially Flavored

6 FL OZ (180 mL)

For Ages 12+

Tamper evident: do not use if printed seal under cap is broken or missing.

Distributed by:

*This product is not manufactured or distributed by Reckitt Benckiser, the distributor of Mucinex® Fast -Max® Maximum Strength Severe Congestion & Cough Clear & Cool™.

CVS Maximum Strength Severe Congestion & cough
CVS Maximum Strength Severe Congestion & cough

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69842-76769842-767-06

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
dextromethorphan hydrobromide9D2RTI9KYHACTIB
guaifenesin495W7451VQACTIB
phenylephrine hydrochloride04JA59TNSJACTIB
anhydrous citric acidXF417D3PSLIACT
D&C YELLOW NO. 1035SW5USQ3GIACT
edetate disodium7FLD91C86KIACT
FD&C Blue NO. 1H3R47K3TBDIACT
POTASSIUM CITRATEEE90ONI6FFIACT
propylene glycol6DC9Q167V3IACT
propyl gallate8D4SNN7V92IACT
water059QF0KO0RIACT
sodium benzoateOJ245FE5EUIACT
sorbitol506T60A25RIACT
sucralose96K6UQ3ZD4IACT
xanthan gumTTV12P4NEEIACT

Source Document#

Source XML · Source PDF

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
72025-12-10full-release2026-06-01 01:21:41

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CVS Maximum Strength Severe Congestion and CoughDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDECVS PHARMACY, INCbfb3d021-f65f-499c-bbb1-c1aceb7a7bf92026-08-19WarningsExact identifier
ndc (package): 69842-767-06
ndc (product): 69842-767
ndc11 (package): 69842076706
spl id: 5768c53a-cbb8-4503-9e6a-270a40bf53d5
spl set id: bfb3d021-f65f-499c-bbb1-c1aceb7a7bf9

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.