Storage and handling
Other information store at 20°C-25°C (68°F -77°F) avoid excessive heat above 40°C (104°F) protect from light
Robitussin Direct Cough - Haleon US Holdings LLC
- Manufacturer
- Haleon US Holdings LLC
- Effective date
- 2026-07-30
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- daily-update
- Hydrated at
- 2026-08-04 03:33:31
Label at a glance#
ProductRobitussin Direct Cough
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE
Label structure10 sections
Contacts and useful links#
Websitewww.stopmedicineabuse.org
www.StopMedicineAbuse.org
www.StopMedicineAbuse.orgWebsitewww.robitussin.com
www.robitussin.com
www.robitussin.comLabel contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Active ingredient (in each liquid-filled capsule)
Dextromethorphan HBr, USP 15 mg
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
- a cough that occurs with too much phlegm (mucus)
- a cough that lasts or is chronic as occurs with smoking, asthma, or emphysema
OTC - STOP USE SECTION
Stop use and ask a doctor ifcough lasts for 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 8 capsules in any 24-hour period
- this adult product is not intended for use in children under 12 years of age
adults and children 12 years and over | take 1 capsule (15 mg) every 4 hours, as required |
children under 12 years | do not use |
STORAGE AND HANDLING SECTION
Other information
- store at 20°C-25°C (68°F -77°F)
- avoid excessive heat above 40°C (104°F)
- protect from light
INACTIVE INGREDIENT SECTION
Inactive ingredients
FD&C blue no. 1, FD&C red no. 40, fractionated coconut oil, gelatin, glycerin, mannitol, pharmaceutical ink, polyethylene glycol, povidone, propyl gallate, propylene glycol, purified water, sorbitol, sorbitol anhydrides
OTC - QUESTIONS SECTION
Questions or comments?
Call weekdays from 9 AM-5 PM EST at 1-800-245-1040
Additional Information
Do not use if safety seal under cap printed with “Sealed for Your Protection” is broken or missing.
Should be 18 or older to purchase
PARENTS:
Learn about teen medicine abuse
Lift Here for More Drug Facts
Distributed by: GSK Consumer Healthcare, Warren, NJ 07059
visit www.robitussin.com
Trademarks owned or licensed by GSK.
©2022 GSK or licensor.
Made in India
PRINCIPAL DISPLAY PANEL
NEW
Robitussin
Cough
Dextromethorphan HBr
(Cough Suppressant)
direct
Actual size
18
Liqui-Gels
®*
*Liquid filled capsules
L-0630-782-44-UPC_ORG Front Label
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| bf324df6-7127-7deb-def5-2681c136cd03 | Product name | 3 | 20250325 |
| 43a1ed49-eae2-4840-8075-cb4b33478540 | Product name | 1 | 20230425 |
| ba088a92-ab5e-b2d4-e908-f5ea691b7587 | Product name | 7 | 20210201 |
| 76633df9-0d59-4b88-03ed-21dee1b966f8 | Product name | 1 | 20140508 |
Products#
Every source-derived product name is available through these pages.
- Robitussin Direct Cough
- dextromethorphan hydrobromide
- DEXTROMETHORPHAN
- FD&C BLUE NO. 1
- FD&C RED NO. 40
- COCONUT OIL
- GELATIN, UNSPECIFIED
- GLYCERIN
- MANNITOL
- POLYETHYLENE GLYCOL, UNSPECIFIED
- POVIDONE, UNSPECIFIED
- PROPYL GALLATE
- PROPYLENE GLYCOL
- WATER
- SORBITOL
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0031-9302 | 0031-9302-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| COCONUT OIL | Q9L0O73W7L | IACT |
| GELATIN, UNSPECIFIED | 2G86QN327L | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| MANNITOL | 3OWL53L36A | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| POVIDONE, UNSPECIFIED | FZ989GH94E | IACT |
| PROPYL GALLATE | 8D4SNN7V92 | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| WATER | 059QF0KO0R | IACT |
| SORBITOL | 506T60A25R | IACT |
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 3 | 2024-03-18 | full-release | 2026-06-01 00:09:56 |
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 Direct Cough | DEXTROMETHORPHAN HYDROBROMIDE | Haleon US Holdings LLC | 70c9556b-063a-4fb3-96f6-1d4ffa495ed4 | 2026-07-30 | Warnings | 0031-9302-01 0031-9302 00031930201 57d72c9c-b950-1fa9-e063-6394a90a9360 70c9556b-063a-4fb3-96f6-1d4ffa495ed4 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.