Chest Congestion Relief

Manufacturer
Mckesson
Effective date
2016-12-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:48:13

Label at a glance#

ProductChest Congestion Relief
Active ingredientGUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE
Label structure10 sections

Indications and uses

temporarily relieves cough due to minor throat and bronchial irritation associated with the common cold helps loosen phelgm (mucus) and thin bronchial secretions to make coughs more productive

Dosage and administration

take with full glass of water; 1 tablet every 4 hours do not take more than 6 tablets in 24 hours children under 12 years: do not use

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

(in each intermediate release tablet)

Guaifenesin 400 mg

Dextromethorphan HBr 20 mg

Purpose

OTC - PURPOSE SECTION

Expectorant

Cough Suppressant

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves cough due to minor throat and bronchial irritation associated with the common cold
  • helps loosen phelgm (mucus) and thin bronchial secretions to make coughs more productive

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 your prescription drug contains an MAOI ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

  • cough accompanied by too much of phelgm (mucus)
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • when using this product do not use more than directed

Stop use and ask doctor if

Cough lasts more than 7 days, comes back, or occurs with 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • take with full glass of water;

    1 tablet every 4 hours

  • do not take more than 6 tablets in 24 hours
  • children under 12 years: do not use

Other Information

SPL UNCLASSIFIED SECTION

  • store at 25° C(77°F) ; excursion permitted between 15°-30° C (59°-86°F)
  • see end flap for expiration date and lot number
  • metal content per tablet:
  • sodium 7mg, Magnesium 1mg

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Colloidal Silicon Dioxide, Hypromellose, Microcrystalline cellulose, Magnesium stearate, Polyethylene Glycol, Stearic Acid powder, Sodium Starch Glycolate

Questions or Comments

OTC - QUESTIONS SECTION

Call 1-855-314-1850

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

aa8e63bc-figure-01
aa8e63bc-figure-01
aa8e63bc-figure-02
aa8e63bc-figure-02

NDC 70677-0012-1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1147685dextromethorphan HBr 20 MG / guaiFENesin 400 MG Oral TabletPSN1
1147685dextromethorphan hydrobromide 20 MG / guaifenesin 400 MG Oral TabletSCD1
1147685guaifenesin 400 MG / dextromethorphan HBr 20 MG Oral TabletSY1

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70677-0012-12020-01-31C16284748780-19d75b9d0-f4e7-f424-e053-dadaa90a57ceGuaifenesin 400 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70677-0012-1Chest Congestion Relief50 in 1 BOTTLETABLET501
70677-0012-1Chest Congestion Relief1 in 1 CARTONTABLET11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70677-0012CHEST CONGESTION RELIEF (GUAIFENESIN AND DEXTROMETHORPHAN HBR) TABLET [MCKESSON]1Legacy NDC, 2 package rows20161220_6c27d44a-a6dc-4e64-8b9e-ab91dd9aa9ce.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70677-001270677-0012-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 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
aa8e63bc-bdf8-4e91-9d13-a6b9a8f52c2d6c27d44a-a6dc-4e64-8b9e-ab91dd9aa9ce2016-12-18WarningsExact identifier
spl id: aa8e63bc-bdf8-4e91-9d13-a6b9a8f52c2d
spl set id: 6c27d44a-a6dc-4e64-8b9e-ab91dd9aa9ce

Reported adverse events (FAERS/openFDA)#

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