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

Key Label Information#

Active Ingredients And Purpose

Active ingredients (in each 20 mL)

Dextromethorphan HBr 30 mg Doxylamine Succinate 12.5 mg

Uses

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

Warnings

Warnings

Directions And Dosage

Directions

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

Other Label Information

Other information

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

Inactive ingredients

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?

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

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

Label Images#

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

Products#

NDC Codes#

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

Ingredients#

Complete SPL Sections#

Active ingredients (in each 20 mL)

OTC - ACTIVE INGREDIENT SECTION

Dextromethorphan HBr 30 mg Doxylamine Succinate 12.5 mg

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

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 age dose 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

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

Source Document#

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