FDA.reportPublic FDA data

CVS Maximum Strength Severe Congestion and Cough

Manufacturer
CVS
Effective date
2020-04-13
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:06:05

Label at a glance#

ProductCVS Maximum Strength Severe Congestion and Cough Overnight Cold and Flu Clear and cool
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, Guaifenesin, PHENYLEPHRINE HYDROCHLORIDE, Acetaminophen, TRIPROLIDINE HYDROCHLORIDE
Label structure12 sections

Indications and uses

MAXIMUM STRENGTH SEVERE CONGESTION & COUGH ▪ 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 ▪ low sodium ▪ store at room temperature ▪ do not refrigerate ▪ dosing cup provided

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients (in each 20 mL)
Maximum Strength Severe Congestion & Cough		Purposes

Dextromethorphan HBr 20 mg

Cough suppressant

Guaifenesin 400 mg

Phenylephrine HCl 10 mg

Expectorant

Nasal decongestant

Active ingredients (in each 20 mL)Purposes
Overnight Cold & Flu Clear & Cool

Acetaminophen 650 mg

Pain reliever/fever reducer

Dextromethorphan HBr 20 mg

Phenylephrine HCl 10 mg

Antihistamine/cough suppressant

Nasal decongestant

Triprolidine HCl 2.5 mg

Antihistamine

Uses

INDICATIONS & USAGE SECTION

MAXIMUM STRENGTH SEVERE CONGESTION & COUGH

  • 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

  • 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

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

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 Centre 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
  • low sodium
  • store at room temperature
  • do not refrigerate
  • dosing cup provided

Inactive ingredients (Maximum strength mucus relief DM)

INACTIVE INGREDIENT SECTION

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

Uses (OVERNIGHT COLD & FLU CLEAR & COOL

INDICATIONS & USAGE SECTION

  • temporarily relieves these common cold and flu symptoms:
  • cough
  • nasal congestion
  • minor aches and pains
  • sore throat
  • headache
  • runny nose
  • sneezing
  • itching of the nose or throat
  • itchy, watery eyes due to hay fever
  • temporarily reduces fever
  • controls cough to help you get to sleep

Warnings

WARNINGS SECTION

Liver warnings: This product contains acetaminophen. Severe liver damage may occur if you take\

  • more than 4000 mg in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks daily while using this product

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

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Centre right away at 1-800-222-1222.

Quick medical attention is critical for adults as well as for children, even if you do not notice any signs

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not take more than directed (see overdose warnings
  • do not take more than 4 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
  • adults and children 12 years of age and over: 20 ml in dosing cup provided every 4 hours
  • children under 12 years of age: do not use
Other Information

OTHER SAFETY INFORMATION

  • each 20 mL contains: sodium 10 mg
  • store at room temperature
  • do not refrigerate

Inactive ingredients (Overnight Cold & Flu)

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

(1-866-467-2748)

PRINCIPAL DISPLAY PANEL - Kit Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

VALUE PACK

NDC 69842-967-12

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

Maximum Strength

Severe Congestion & Cough

Dextromethorphan HBr • Cough Suppressant
Guaifenesin • Expectorant

Phenylephrine HCl • Nasal Decongestant

  • Controls Cough
  • Relieves Nasal & Chest Congestion
  • Thins & Loosens Mucus

Cooling Menthol Flavor

Naturally and Artificially Flavored

For Ages 12+

6 FL. OZ. (180 mL)

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

Compare to Mucinex® Nightshift Cold & Flu Clear & Cool Active Ingredients**

Overnight Cold & Flu

Clear & Cool

Acetaminophen • Pain Reliever/Fever Reducer
Dextromethorphan HBr • Cough Suppressant
Phenylephrine HCl • Nasal Decongestant

Triprolidine HCl • Antihistamine

Maximum Strength per 4-hour dose

Night Time Relief for a Better Morning

  • Cough
  • Fever
  • Sore Throat
  • Runny Nose
  • Sneezing
  • Nasal Congestion

For Ages 12+

6 FL OZ (180 mL)

**This product is not manufactured or distributed by RB Health, the distributor of Mucinex® Nightshift Cold & Flu Clear & Cool.

DO NOT TAKE MAXIMUM STRENGTH SEVERE CONGESTION & COUGH & OVERNIGHT COLD & FLU CLEAR & COOL LIQUIDS AT THE SAME TIME.

CVS Value Pack Maximum Strength Severe Congestion & Cough Overnight Cold and Flu Clear and cool
CVS Value Pack Maximum Strength Severe Congestion & Cough Overnight Cold and Flu Clear and cool

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2288826{1 (acetaminophen 32.5 MG/ML / dextromethorphan hydrobromide 1 MG/ML / phenylephrine hydrochloride 0.5 MG/ML / triprolidine hydrochloride 0.125 MG/ML Oral Solution) / 1 (dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution) } PackGPCK1
22888261 daytime (dextromethorphan HBr 20 MG / guaiFENesin 400 MG / phenylephrine HCl 10 MG in 20 mL Oral Solution) / 1 nighttime (acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG / triprolidine HCl 2.5 MG in 20 mL Oral Solution) PackPSN1
2173662acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG / triprolidine HCl 2.5 MG in 20 mL Oral SolutionPSN1
1043543dextromethorphan HBr 5 MG / guaiFENesin 100 MG / phenylephrine HCl 2.5 MG in 5 mL Oral SolutionPSN1
2173662acetaminophen 32.5 MG/ML / dextromethorphan hydrobromide 1 MG/ML / phenylephrine hydrochloride 0.5 MG/ML / triprolidine hydrochloride 0.125 MG/ML Oral SolutionSCD1
1043543dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral SolutionSCD1
22888261 daytime (dextromethorphan HBr 20 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 20 ML Oral Solution) / 1 nighttime (acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG / triprolidine HCl 2.5 MG per 20 ML Oral Solution) PackSY1
2173662acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG / triprolidine hydrochloride 1.25 MG per 10 mL Oral SolutionSY1
2173662acetaminophen 650 MG / dextromethorphan hydrobromide 20 MG / phenylephrine hydrochloride 10 MG / triprolidine hydrochloride 2.5 MG per 20 mL Oral SolutionSY1
2173662APAP 32.5 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / Phenylephrine Hydrochloride 0.5 MG/ML / Triprolidine Hydrochloride 0.125 MG/ML Oral SolutionSY1
1043543dextromethorphan HBr 20 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 20 ML Oral SolutionSY1
1043543dextromethorphan HBr 5 MG / guaifenesin 100 MG / phenylephrine HCl 2.5 MG per 5 ML Oral SolutionSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
GUAIFENESIN Pharmacologic Class Indexing1Indexing - Pharmacologic Class20211129
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69842-967-122022-01-28C16284748780-1d6a99b39-d6bc-a426-e053-dadaa90af4c2Maximum Strength Severe Congestion & Cough and Overnight Cold & Flu Value Pack

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69842-967-12CVS Maximum Strength Severe Congestion and CoughOvernight Cold and Flu Clear and cool1 in 1 CARTONKIT11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-967CVS MAXIMUM STRENGTH SEVERE CONGESTION AND COUGH OVERNIGHT COLD AND FLU CLEAR AND COOL (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN AND TRIPROLIDINE HCL) KIT [CVS]1Legacy NDC, 1 package rows20200413_d90ee70c-59df-4976-b66b-b8ece17f744a.zip

Products#

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

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69842-96769842-967-12

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 33 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
Acetaminophen362O9ITL9DACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
TRIPROLIDINE HYDROCHLORIDEYAN7R5L890ACTIB
anhydrous citric acidXF417D3PSLIACT
ASCORBIC ACIDPQ6CK8PD0RIACT
D&C YELLOW NO. 1035SW5USQ3GIACT
edetate disodium7FLD91C86KIACT
FD&C Blue No. 1H3R47K3TBDIACT
glycerinPDC6A3C0OXIACT
propyl gallate8D4SNN7V92IACT
propylene glycol6DC9Q167V3IACT
water059QF0KO0RIACT
sodium benzoateOJ245FE5EUIACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
sorbitol506T60A25RIACT
sucralose96K6UQ3ZD4IACT
xanthan gumTTV12P4NEEIACT

Source Document#

Source XML

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
d90ee70c-59df-4976-b66b-b8ece17f744ad90ee70c-59df-4976-b66b-b8ece17f744a2020-04-13WarningsExact identifier
spl id: d90ee70c-59df-4976-b66b-b8ece17f744a
spl set id: d90ee70c-59df-4976-b66b-b8ece17f744a

Reported adverse events (FAERS/openFDA)#

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