FDA.reportPublic FDA data

Robitussin Honey Maximum Strength Cough and Chest Congestion DM

Manufacturer
Haleon US Holdings LLC
Effective date
2024-05-03
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 00:12:00

Label at a glance#

ProductRobitussin Honey Maximum Strength Cough and Chest Congestion DM
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN
Label structure10 sections

Storage and handling

Other information each 20 mL contains : sodium 21 mg store at 20-25°C (68-77°F). Do not refrigerate.

Label contents#

Full prescribing information#

Active ingredients (in each 20 mL)

OTC - ACTIVE INGREDIENT SECTION

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Purposes

OTC - PURPOSE SECTION

Cough suppressant

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.

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 21 mg
  • store at 20-25°C (68-77°F). Do not refrigerate.

INACTIVE INGREDIENT SECTION

Inactive ingredients

anhydrous citric acid, carboxymethylcellulose sodium, glycerin, natural and artificial flavors, natural grade A honey, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium gluconate, sucralose, xanthan gum, zinc gluconate

OTC - QUESTIONS SECTION

Questions or comments?

call weekdays from 8 AM to 6 PM EST at 1-800-245-1040

Additional information

SPL UNCLASSIFIED SECTION

Packaged with Tamper-Evident bottle cap.

Do Not Use if breakable ring is separated or missing.

Dist. by: Haleon, Warren, NJ 07059

©2024 Haleon or licensor.

Trademarks owned or licensed by Haleon.

For most recent product information, visit www.robitussin.com

Pat. Info www.productpats.com Made in Canada

PARENTS:

Learn about teen medicine abuse

www.StopMedicineAbuse.org

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ADULT

Robitussin

Honey

Cough+Chest
Congestion DM

DEXTROMETHORPHAN HBr (Cough Suppressant)
GUAIFENESIN (Expectorant)

MAXIMUM STRENGTH

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

Taste the
Real Honey

DM
MAX

For Ages 12+
4 FL OZ (118 mL)

62000000211563 Carton Front

Robitussin Honey C+CC DM Max 4 fl oz (118 ml)
Robitussin Honey C+CC DM Max 4 fl oz (118 ml)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1020138dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 20 mL Oral SolutionPSN8
1020138dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCD8
1020138dextromethorphan HBr 20 MG / guaifenesin 400 MG per 20 ML Oral SolutionSY8
1020138dextromethorphan HBr 5 MG / guaifenesin 100 MG per 5 ML Oral SolutionSY8

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
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0031-8756-12Robitussin Honey Maximum Strength Cough and Chest Congestion DM118 mL in 1 BOTTLESOLUTION1188
0031-8756-12Robitussin Honey Maximum Strength Cough and Chest Congestion DM1 in 1 CARTONSOLUTION18
0031-8756-18Robitussin Honey Maximum Strength Cough and Chest Congestion DM1 in 1 CARTONSOLUTION18
0031-8756-18Robitussin Honey Maximum Strength Cough and Chest Congestion DM237 mL in 1 BOTTLESOLUTION2378

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0031-8756ROBITUSSIN HONEY MAXIMUM STRENGTH COUGH AND CHEST CONGESTION DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) SOLUTION [HALEON US HOLDINGS LLC]8Current NDC, Legacy NDC, 4 package rows20240504_eaa10aed-5b1e-48bf-bc05-7a5638851daf.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0031-8756-12ML - Milliliter0031-87568416ba12-afa1-4752-97ab-31d20f644e5f12019-07-02
0031-8756-18ML - Milliliter0031-8756913071af-382f-4fe6-ad2d-df68bbb113a912019-08-06

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
0031-87560031-8756-12, 0031-8756-18

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
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
SODIUM GLUCONATER6Q3791S76IACT
SUCRALOSE96K6UQ3ZD4IACT
XANTHAN GUMTTV12P4NEEIACT
ZINC GLUCONATEU6WSN5SQ1ZIACT
HONEYY9H1V576FHIACT
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
GUAIFENESIN495W7451VQACTIB

Source Document#

Source XML · Source PDF

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Robitussin Honey Cough DM Day Night Value PackDEXTROMETHORPHAN HBR, GUAIFENESIN, DOXYLAMINE SUCCINATEHaleon US Holdings LLC1bbd0157-06e6-4a3b-bac9-91ac879ba0892025-11-06WarningsExact identifier
ndc (package): 0031-8756-12
ndc11 (package): 00031875612
Robitussin Honey Maximum Strength Cough and Chest Congestion DMDEXTROMETHORPHAN HBR, GUAIFENESINHaleon US Holdings LLCeaa10aed-5b1e-48bf-bc05-7a5638851daf2024-05-03WarningsExact identifier
ndc (package): 0031-8756-18
ndc (package): 0031-8756-12
ndc (product): 0031-8756
ndc11 (package): 00031875618
ndc11 (package): 00031875612
spl id: 178d098c-514f-d1fe-e063-6294a90af6ca
spl set id: eaa10aed-5b1e-48bf-bc05-7a5638851daf

Reported adverse events (FAERS/openFDA)#

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