FDA.reportPublic FDA data

Adult Cough plus Chest Congestion DM

Manufacturer
WALGREEN COMPANY
Effective date
2025-12-01
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:18:52

Label at a glance#

ProductAdult Cough plus Chest Congestion DM with Honey
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN
Label structure9 sections

Storage and handling

Other information each 20 ml contains: sodium 10 mg store at room temperature. Do not refrigerate.

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, USP 20 mg

Cough suppressant

Guaifenesin, USP 400 mg

Expectorant

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

Warnings

OTC - DO NOT USE SECTION

Do not useif 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 ifcough 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 at 1-800-222-1222.

DOSAGE & ADMINISTRATION SECTION

Directions

  • do not take more than 6 doses in any 24-hour period
  • measure only with dosing cup provided
  • keep dosing cup with product
  • ml = milliliter
  • this adult product is not intended for use in children under 12 years of age
agedose

adults and children 12 years and over

20 ml every 4 hours

children under 12 years

do not use

STORAGE AND HANDLING SECTION

Other information

  • each 20 ml contains:sodium 10 mg
  • store at room temperature. Do not refrigerate.

INACTIVE INGREDIENT SECTION

Inactive ingredients

citric acid, carboxymethylcellulose sodium, edetate disodium, glycerin, honey, natural & artificial flavors, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sucralose, xanthan gum, zinc gluconate

OTC - QUESTIONS SECTION

Questions or comments?

1-866-467-2748

PRINCIPAL DISPLAY PANEL - 118 ml Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to active ingredients in Robitussin® Honey Cough + Chest Congestion DM MAX*

NDC 0363-7754-04

Adult

Cough + Chest

Congestion DM

With Honey

Dextromethorphan HBr (Cough Suppressant)
Guaifenesin (Expectorant)

Maximum Strength

DM MAX

  • Controls Cough
  • Relieves Chest Congestion
  • Thins & Loosens Mucus
  • Gluten Free
  • No Artificial Colors
  • No Added Alcohol

Taste the Real Honey

For Ages 12 & Over

4 FL OZ (118 ml)

*This product is not manufactured or distributed by GSK Consumer Healthcare, distributor of Adult Robitussin® Honey Cough + Chest Congestion DM MAX.

TAMPER EVIDENT: DON NOT USE IF PRINTED INNER SEAL UNDER CAP IS TORN OR MISSING

IMPORTANT:Keep this carton for future reference for full labelling.

Distributed by:

WAG Adult Cough+ Chest Congestion DM with Honey
WAG Adult Cough+ Chest Congestion DM with Honey

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1020138dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 20 mL Oral SolutionPSN3
1020138dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCD3
1020138dextromethorphan HBr 20 MG / guaifenesin 400 MG per 20 ML Oral SolutionSY3
1020138dextromethorphan HBr 5 MG / guaifenesin 100 MG per 5 ML Oral SolutionSY3

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
0363-7754-04Adult Cough plus Chest Congestion DMwith Honey118 mL in 1 BOTTLESOLUTION1183
0363-7754-04Adult Cough plus Chest Congestion DMwith Honey1 in 1 CARTONSOLUTION13

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0363-77540363-7754-04

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
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDK679OBS311IACT
EDETATE DISODIUM7FLD91C86KIACT
GLYCERINPDC6A3C0OXIACT
HONEYY9H1V576FHIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
SUCRALOSE96K6UQ3ZD4IACT
XANTHAN GUMTTV12P4NEEIACT
ZINC GLUCONATEU6WSN5SQ1ZIACT
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
GUAIFENESIN495W7451VQACTIB

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
Adult Cough plus Chest Congestion DM with HoneyDEXTROMETHORPHAN HBR, GUAIFENESINWALGREEN COMPANY5f5af13a-c2a3-4bbe-880e-9c57b36e92342025-12-01WarningsExact identifier
ndc (package): 0363-7754-04
ndc (product): 0363-7754
ndc11 (package): 00363775404
spl id: 44e1cc69-f82c-8f00-e063-6394a90aabda
spl set id: 5f5af13a-c2a3-4bbe-880e-9c57b36e9234

Reported adverse events (FAERS/openFDA)#

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