FDA.reportPublic FDA data

CVS 44-004

Manufacturer
CVS PHARMACY | LNK International, Inc.
Effective date
2026-07-21
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
daily-update
Hydrated at
2026-07-29 05:10:08

Label at a glance#

ProductSevere Cough and Congestion
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
Label structure9 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 the impulse to cough to help you get to sleep nasal congestion due to a cold

Dosage and administration

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

Storage and handling

each 20 mL contains: sodium 9 mg use by expiration date on package store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

Label contents#

Full prescribing information#

Active ingredients (in each 20 mL)

OTC - ACTIVE INGREDIENT SECTION

Dextromethorphan HBr 20 mg
Guaifenesin 400 mg
Phenylephrine HCl 10 mg

Purpose

OTC - PURPOSE SECTION

Cough suppressant
Expectorant
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
    • the impulse to cough to help you get to sleep
    • nasal congestion due to a cold

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

  • 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
  • high blood pressure
  • heart disease
  • diabetes
  • cough that occurs with too much phlegm (mucus)

When using this product

OTC - WHEN USING SECTION

do not exceed recommended dosage.

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 persists more than 1 week, 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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

STORAGE AND HANDLING SECTION

  • each 20 mL contains: sodium 9 mg
  • use by expiration date on package
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

1-800-426-9391

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 69842-942-45

♥CVS™

Mixed Berry Flavor

Maximum Strength†
SEVERE
CONGESTION
& COUGH

Dextromethorphan HBr
Cough Suppressant
Guaifenesin, Expectorant
Phenylephrine HCl, Nasal Decongestant

Compare to Maximum Strength
Mucinex® FAST-MAX® Severe
Congestion & Cough active ingredients*

Multi-Symptom | Relieves Nasal
& Chest Congestion | Controls Cough
Thins & Loosens Mucus

6 FL OZ (177 mL)

Ages 12
& Older

†Under OTC monograph.

CVS 44-004
CVS 44-004

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
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bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
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0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
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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
69842-94269842-942-45

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
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C RED NO. 40WZB9127XOAIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
TRISODIUM CITRATE DIHYDRATEB22547B95KIACT
SODIUM METABISULFITE4VON5FNS3CIACT
SORBITOL506T60A25RIACT
SUCRALOSE96K6UQ3ZD4IACT
XANTHAN GUMTTV12P4NEEIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
82025-12-11full-release2026-06-01 01:22:16

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
Severe Cough and CongestionDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLCVS PHARMACY791eaac1-ddb5-40e2-9040-52dfadc30e062026-07-21WarningsExact identifier
ndc (package): 69842-942-45
ndc (product): 69842-942
ndc11 (package): 69842094245
spl id: 82907873-0af8-4b64-8b08-d00b362bf921
spl set id: 791eaac1-ddb5-40e2-9040-52dfadc30e06

Reported adverse events (FAERS/openFDA)#

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