FDA.reportPublic FDA data

ROBITUSSIN Nighttime Cough DM Soft CHEWS

Manufacturer
Haleon US Holdings LLC
Effective date
2025-11-25
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:18:01

Label at a glance#

ProductROBITUSSIN Nighttime Cough DM Soft CHEWS
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE
Label structure10 sections

Storage and handling

Other information each chewable tablet contains: calcium 10 mg, potassium 10 mg, sodium 7 mg store at 20-25°C (68-77°F)

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each chewable tablet)

Dextromethorphan equivalent to 15 mg dextromethorphan HBr

Doxylamine succinate 6.25 mg

OTC - PURPOSE SECTION

Purposes

Cough suppressant

Antihistamine

INDICATIONS & USAGE SECTION

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 SECTION

Warnings

OTC - DO NOT USE SECTION

Do not use

  • 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 is chronic such as occurs with smoking, asthma, or chronic bronchitis or emphysema

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking sedatives or tranquilizers

When using this product

OTC - WHEN USING SECTION

  • 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.

DOSAGE & ADMINISTRATION SECTION

Directions

  • do not take more than 4 doses (8 chewable tablets) in 24-hours, unless directed by a doctor.
  • chew tablets completely before swallowing
  • this adult product is not intended for use in children under 12 years of age
agedose

adults and children 12 years and over

take 2 chewable tablets every 6 hours, as needed

children under 12 years

do not use

STORAGE AND HANDLING SECTION

Other information

  • each chewable tablet contains:calcium 10 mg, potassium 10 mg, sodium 7 mg
  • store at 20-25°C (68-77°F)

INACTIVE INGREDIENT SECTION

Inactive ingredients

calcium gluconate monohydrate, carboxymethylcellulose calcium, carnauba wax, corn syrup solids, crospovidone, D&C red no. 30 aluminum lake, FD&C blue no. 1 aluminum lake, glycerin, mannitol, natural and artificial flavors, pregelatinized starch, simethicone, sodium gluconate, sorbitol, sorbitol solution, sucralose, sucrose, whole dry milk

OTC - QUESTIONS SECTION

Questions or comments?

call weekdays from 8 AM to 6 PM EST at 1-855-297-3031

Additional Information

SPL UNCLASSIFIED SECTION

Do Not Use if seal under bottle cap imprinted with “SEALED for YOUR PROTECTION” is broken or missing.

*Among those with a preference vs. original formulation

PARENTS:

Learn about teen medicine abuse

www.StopMedicineabuse.org

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NEW!IMPROVED FLAVOR*

Robitussin

Nighttime Cough DM

Soft CHEWS

DEXTROMETHORPHAN HBr 15 mg
(Cough Suppressant)

DOXYLAMINE SUCCINATE 6.25 mg

(Antihistamine)

FAST reliefANYWHERE

Cough, runny nose & sneezing

20 CHEWABLE TABLETS

Chew tablets completely before swallowing

UP TO 8HRCOUGH RELIEF

Berry flavor

Robitussin NT Cough DM Soft Chews 20 ct
Robitussin NT Cough DM Soft Chews 20 ct

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2685210dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Chewable TabletPSN2
2685210dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Chewable TabletSCD2

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
e0d2eb29-08bd-4bba-90d1-c91c68a38767Product name420250516
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
e92765c1-be81-432a-b909-1b10777ec378Product name120190208
f4368033-af8c-41bf-a84b-ff77392b8522Product name120161229
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0031-9311-20ROBITUSSIN Nighttime Cough DM Soft CHEWS20 in 1 BOTTLETABLET, CHEWABLE202

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0031-93110031-9311-20

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
SUCRALOSE96K6UQ3ZD4IACT
SUCROSEC151H8M554IACT
COW MILK917J3173FTIACT
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
DOXYLAMINE SUCCINATEV9BI9B5YI2ACTIB
CALCIUM GLUCONATE MONOHYDRATECZN0MI5R31IACT
CARBOXYMETHYLCELLULOSE CALCIUMUTY7PDF93LIACT
CARNAUBA WAXR12CBM0EIZIACT
CORN SYRUP9G5L16BK6NIACT
CROSPOVIDONE, UNSPECIFIED2S7830E561IACT
D&C RED NO. 30 ALUMINUM LAKEGE75M6YV5WIACT
GLYCERINPDC6A3C0OXIACT
MANNITOL3OWL53L36AIACT
STARCH, CORNO8232NY3SJIACT
DIMETHICONE, UNSPECIFIED92RU3N3Y1OIACT
SODIUM GLUCONATER6Q3791S76IACT
SORBITOL506T60A25RIACT
SORBITOL SOLUTION8KW3E207O2IACT

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
ROBITUSSIN Nighttime Cough DM Soft CHEWSDEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEHaleon US Holdings LLC39468746-e06d-4849-9d06-9af4d14351b02025-11-25WarningsExact identifier
ndc (package): 0031-9311-20
ndc (product): 0031-9311
ndc11 (package): 00031931120
spl id: 4472847f-6aad-ca49-e063-6394a90a7ff3
spl set id: 39468746-e06d-4849-9d06-9af4d14351b0

Reported adverse events (FAERS/openFDA)#

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