MAXIMUM STRENGTH CHEST CONGESTION AND COUGH

Manufacturer
CVS PHARMACY, INC.
Effective date
2024-12-18
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:44:36

Label at a glance#

ProductMAXIMUM STRENGTH CHEST CONGESTION AND COUGH
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN
Label structure9 sections

Indications and uses

temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes

Dosage and administration

do not take more than 12 softgels in any 24-hour period this adult product is not intended for use in children under 12 years of age age dose adults and children 12 years and over 2 softgels every 4 hours children under 12 years do not use

Storage and handling

store at 20-25°C (68-77°F). avoid excessive heat above 40°C (104°F).

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients (in each softgel)Purposes
Dextromethorphan HBr, USP 10 mgCough suppressant
Guaifenesin, USP 200 mgExpectorant

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes

Warnings

WARNINGS SECTION

OTC - DO NOT USE 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

  • cough that occurs with too much phlegm (mucus)
  • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema

OTC - STOP USE SECTION

Stop use and ask a doctor if cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. 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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not take more than 12 softgels in any 24-hour period
  • this adult product is not intended for use in children under 12 years of age
agedose
adults and children 12 years and over2 softgels every 4 hours
children under 12 yearsdo not use

Other information

STORAGE AND HANDLING SECTION

  • store at 20-25°C (68-77°F).
  • avoid excessive heat above 40°C (104°F).

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C Red-40, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, special sorbitol, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

1-888-333-9792

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to the active ingredients in Robitussin® Maximum

Strength Cough+Chest Congestion DM*

Maximum Strength

Cough + Chest Congestion DM

DEXTROMETHORPHAN HBr / COUGH SUPPRESSANT

GUAIFENESIN/ EXPECTORANT

MAXIMUM STRENGTH

Relieves

cough

chest congestion

20 SOFTGELS

CVS HBPCVS HBP

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1111663dextromethorphan HBr 10 MG / guaiFENesin 200 MG Oral CapsulePSN6
1111663dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG Oral CapsuleSCD6

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69842-783-20MAXIMUM STRENGTH CHEST CONGESTION AND COUGH10 in 1 BLISTER PACKCAPSULE, GELATIN COATED106
69842-783-20MAXIMUM STRENGTH CHEST CONGESTION AND COUGH2 in 1 CARTONCAPSULE, GELATIN COATED26

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-783MAXIMUM STRENGTH CHEST CONGESTION AND COUGH (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) CAPSULE, GELATIN COATED [CVS PHARMACY, INC.]6Legacy NDC, 2 package rows20241220_3d9852cd-0a2b-4935-89dd-05da40b626fd.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69842-783-20EA - Each69842-7839a65f98c-dc70-4269-8a23-a37f864d9fce12021-12-08

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69842-78369842-783-20

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

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
29932528-c152-ca8a-e063-6394a90a5b343d9852cd-0a2b-4935-89dd-05da40b626fd2024-12-18WarningsExact identifier
spl id: 29932528-c152-ca8a-e063-6394a90a5b34
spl set id: 3d9852cd-0a2b-4935-89dd-05da40b626fd

Reported adverse events (FAERS/openFDA)#

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