FDA.reportPublic FDA data

Robitussin Honey Maximum Strength Nighttime Cough DM

Manufacturer
Haleon US Holdings LLC
Effective date
2024-05-01
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
full-release
Hydrated at
2026-06-01 00:11:51

Label at a glance#

ProductRobitussin Honey Maximum Strength Nighttime Cough DM
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE
Label structure10 sections

Indications and uses

temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat controls the impulse to cough to help you sleep

Dosage and administration

measure only with dosing cup provided keep dosing cup with product mL = milliliter do not take more than 4 doses 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 20 mL every 6 hours children under 12 years do not use

Storage and handling

each 20 ml contains : sodium 21 mg store at 20-25°C (68-77°F)

Label contents#

Full prescribing information#

Active ingredients (in each 20 mL)

OTC - ACTIVE INGREDIENT SECTION

Dextromethorphan HBr 30 mg

Doxylamine Succinate 12.5 mg

Purposes

OTC - PURPOSE SECTION

Cough suppressant

Antihistamine

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
    • runny nose
    • sneezing
    • itchy, watery eyes
    • itching of the nose or throat
  • controls the impulse to cough to help you sleep

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

  • to sedate a child or to make a child sleepy
  • 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

  • trouble urinating due to an enlarged prostate gland
  • glaucoma
  • a cough that occurs with too much phlegm (mucus)
  • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you aretaking sedatives or tranquilizers

When using this product

OTC - WHEN USING SECTION

  • do not use more than directed
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • measure only with dosing cup provided
  • keep dosing cup with product
  • mL = milliliter
  • do not take more than 4 doses 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 over

20 mL every 6 hours

children under 12 years

do not use

Other information

STORAGE AND HANDLING SECTION

  • each 20 ml contains: sodium 21 mg
  • store at 20-25°C (68-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, blueberry juice concentrate, carboxymethylcellulose sodium, glycerin, lactic acid, 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

Questions or comments?

OTC - QUESTIONS SECTION

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

SPL UNCLASSIFIED SECTION

Distributed by: Pfizer, Madison, NJ 07940 USA

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

Nighttime
Cough DM

DEXTROMETHORPHAN HBr (Cough Suppressant)
DOXYLAMINE SUCCINATE (Antihistamine)

MAXIMUM STRENGTH

  • Controls Cough
  • Relieves runny nose and sneezing

Taste the
Real Honey

DM
NIGHTTIME
MAX

For Ages 12+
4 FL OZ (118 ml)

62000000211557 - Carton

Robitussin Honey MS NT Cough 4 fl ozs (118 ml)
Robitussin Honey MS NT Cough 4 fl ozs (118 ml)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1115329dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 20 mL Oral SolutionPSN10
1115329dextromethorphan hydrobromide 1.5 MG/ML / doxylamine succinate 0.625 MG/ML Oral SolutionSCD10
1115329dextromethorphan hydrobromide 30 MG / doxylamine succinate 12.5 MG per 20 ML Oral SolutionSY10
1115329dextromethorphan hydrobromide 7.5 MG / doxylamine succinate 3.125 MG per 5 ML Oral SolutionSY10

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
DOXYLAMINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
f4368033-af8c-41bf-a84b-ff77392b8522Product name120161229
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0031-8758-12Robitussin Honey Maximum Strength Nighttime Cough DM1 in 1 CARTONSOLUTION110
0031-8758-12Robitussin Honey Maximum Strength Nighttime Cough DM118 mL in 1 BOTTLESOLUTION11810
0031-8758-18Robitussin Honey Maximum Strength Nighttime Cough DM1 in 1 CARTONSOLUTION110
0031-8758-18Robitussin Honey Maximum Strength Nighttime Cough DM237 mL in 1 BOTTLESOLUTION23710

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0031-8758ROBITUSSIN HONEY MAXIMUM STRENGTH NIGHTTIME COUGH DM (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [HALEON US HOLDINGS LLC]10Current NDC, Legacy NDC, 4 package rows20240502_0b41da13-18a1-4987-ae43-1319bfa27484.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0031-8758-12ML - Milliliter0031-8758f347b7e8-eefe-40b3-a382-be63c1019bcd12019-08-06
0031-8758-18ML - Milliliter0031-87583a65a26a-eed3-49ee-9ae9-5ccf8887a83712022-06-06

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0031-87580031-8758-12, 0031-8758-18

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDK679OBS311IACT
GLYCERINPDC6A3C0OXIACT
LACTIC ACID, UNSPECIFIED FORM33X04XA5ATIACT
HONEYY9H1V576FHIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
SODIUM GLUCONATER6Q3791S76IACT
SUCRALOSE96K6UQ3ZD4IACT
XANTHAN GUMTTV12P4NEEIACT
ZINC GLUCONATEU6WSN5SQ1ZIACT
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
DOXYLAMINE SUCCINATEV9BI9B5YI2ACTIB

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): 0031-8758-12
ndc11 (package): 00031875812
Robitussin Honey Maximum Strength Nighttime Cough DMDEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEHaleon US Holdings LLC0b41da13-18a1-4987-ae43-1319bfa274842024-05-01WarningsExact identifier
ndc (package): 0031-8758-18
ndc (package): 0031-8758-12
ndc (product): 0031-8758
ndc11 (package): 00031875818
ndc11 (package): 00031875812
spl id: 176b9197-54b8-217e-e063-6394a90add78
spl set id: 0b41da13-18a1-4987-ae43-1319bfa27484

Reported adverse events (FAERS/openFDA)#

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