Storage and handling
Other information each chewable tablet contains: calcium 10 mg, potassium 10 mg, sodium 6 mg store at a controlled room temperature 20-25°C (68-77°F)
ROBITUSSIN LONG-ACTING COUGH Soft CHEWS
- Manufacturer
- Haleon US Holdings LLC
- Effective date
- 2025-11-25
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- full-release
- Hydrated at
- 2026-06-01 01:18:12
Label at a glance#
ProductROBITUSSIN LONG-ACTING COUGH Soft CHEWS
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE
Label structure10 sections
Contacts and useful links#
Websitewww.stopmedicineabuse.org
www.StopMedicineabuse.org
www.StopMedicineabuse.orgLabel contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Active ingredient (in each chewable tablet)
Dextromethorphan equivalent to 15 mg dextromethorphan HBr
OTC - PURPOSE SECTION
Purpose
Cough suppressant
INDICATIONS & USAGE SECTION
Use
- temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
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
- cough that occurs with too much phlegm (mucus)
- cough that lasts or is chronic such as occurs with smoking, asthma, 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 4 doses (8 chewable tablets) in 24-hours, unless directed by a doctor
- chew tablets completely before swalloing
- this adult product is not intended for use in children under 12 years of age
| age | dose | |
|---|---|---|
adults and children 12 years and over | take 2 chewable tablets every 6 to 8 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 6 mg
- store at a controlled room temperature 20-25°C (68-77°F)
INACTIVE INGREDIENT SECTION
Inactive ingredients
calcium gluconate monohydrate, carboxymethylcellulose calcium, carnauba wax, corn syrup solids, crospovidone, FD&C red no. 40, 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
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
PRINCIPAL DISPLAY PANEL
NEW!IMPROVED FLAVOR*
Robitussin
Long-Acting Cough
Soft CHEWS
DEXTROMETHORPHAN HBr 15 mg
(Cough Suppressant)
FASTrelief ANYWHERE
UP TO 8HRCOUGH RELIEF
10 CHEWABLE TABLETS
Chew tablets completely before swallowing
Berry flavor
DailyMed RxNorm Mappings#
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| DEXTROMETHORPHAN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| e0d2eb29-08bd-4bba-90d1-c91c68a38767 | Product name | 4 | 20250516 |
| 6bd95106-a412-1dad-b9cc-4cb74bfb27ce | Product name | 2 | 20230315 |
| e92765c1-be81-432a-b909-1b10777ec378 | Product name | 1 | 20190208 |
| 290f523a-f9db-9774-b5a9-e1f908ac1782 | Product name | 1 | 20150828 |
| c6b65c52-69c7-df49-550a-a50c137f6218 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0031-9310-10 | ROBITUSSIN LONG-ACTING COUGH Soft CHEWS | 10 in 1 BOTTLE | TABLET, CHEWABLE | 10 | 3 | |
| 0031-9310-20 | ROBITUSSIN LONG-ACTING COUGH Soft CHEWS | 20 in 1 BOTTLE | TABLET, CHEWABLE | 20 | 3 |
Products#
Every source-derived product name is available through these pages.
- ROBITUSSIN LONG-ACTING COUGH Soft CHEWS
- dextromethorphan hydrobromide
- CALCIUM GLUCONATE MONOHYDRATE
- CARBOXYMETHYLCELLULOSE CALCIUM
- CARNAUBA WAX
- CORN SYRUP
- CROSPOVIDONE, UNSPECIFIED
- FD&C RED NO. 40
- GLYCERIN
- MANNITOL
- STARCH, CORN
- DIMETHICONE, UNSPECIFIED
- SODIUM GLUCONATE
- SORBITOL
- SORBITOL SOLUTION
- SUCRALOSE
- SUCROSE
- COW MILK
- DEXTROMETHORPHAN
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0031-9310 | 0031-9310-10, 0031-9310-20 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| ROBITUSSIN LONG-ACTING COUGH Soft CHEWS | DEXTROMETHORPHAN HYDROBROMIDE | Haleon US Holdings LLC | f22248b7-7abd-4df7-a986-dae357ebe8f1 | 2025-11-25 | Warnings | 0031-9310-10 0031-9310-20 0031-9310 00031931010 00031931020 4471f0f1-079c-219b-e063-6294a90ae0bb f22248b7-7abd-4df7-a986-dae357ebe8f1 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.