Storage and handling
Other information • store at 20°-25°C (68°-77°F)
Robitussin Direct Chest Congestion
- Manufacturer
- Haleon US Holdings LLC
- Effective date
- 2024-04-12
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 7
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 21:05:56
Label at a glance#
ProductRobitussin Direct Chest Congestion
Active ingredientGUAIFENESIN
Label structure10 sections
Contacts and useful links#
Websitewww.robitussin.com
www.robitussin.com
www.robitussin.comLabel contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Active ingredient (in each tablet)
Guaifenesin 400 mg
OTC - PURPOSE SECTION
Purpose
Expectorant
INDICATIONS & USAGE SECTION
Use
helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
WARNINGS SECTION
Warnings
Ask a doctor before use if you have
- cough accompanied by too much phlegm (mucus)
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
OTC - STOP USE SECTION
Stop use and ask a doctor if
cough persists more than 7 days, tends to recur, or is accompanied by a 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
- take with a full glass of water
- do not take more than 6 tablets in 24 hours
- do not take more than directed
adults and children 12 years and over | take 1 tablet every 4 hours |
children under 12 years | Do not use |
STORAGE AND HANDLING SECTION
Other information
- store at 20°-25°C (68°-77°F)
INACTIVE INGREDIENT SECTION
Inactive ingredients
FD&C blue no. 1 aluminum lake, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, povidone, silicon dioxide, sodium starch glycolate, stearic acid
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.
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 China
PRINCIPAL DISPLAY PANEL
NEW
Robitussin
Chest Congestion
Guaifenesin
(Expectorant)
direct
Actual size
18
Tablets
L-0630-532-44-UPC_ORG Front Label
Products#
Every source-derived product name is available through these pages.
- Robitussin Direct Chest Congestion
- guaifenesin
- ALUMINUM OXIDE
- HYPROMELLOSE, UNSPECIFIED
- MAGNESIUM STEARATE
- MALTODEXTRIN
- MICROCRYSTALLINE CELLULOSE
- POLYETHYLENE GLYCOL, UNSPECIFIED
- POVIDONE, UNSPECIFIED
- SILICON DIOXIDE
- SODIUM STARCH GLYCOLATE TYPE A CORN
- STEARIC ACID
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0031-9303 | 0031-9303-01 |
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 |
|---|---|---|---|---|---|---|
| 7913f832-10b1-45e8-bc2e-8fc1ae59d817 | 5998b7dd-e376-4ea7-955e-707268e12b0b | 2024-04-12 | Warnings | 7913f832-10b1-45e8-bc2e-8fc1ae59d817 5998b7dd-e376-4ea7-955e-707268e12b0b |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.