Indications and uses
temporarily relieves minor aches and pains due to: sore throat headache backache toothache premenstrual and menstrual cramps the common cold minor pain of arthritis muscular aches temporarily reduces fever
Robitussin Direct Sore Throat Pain
- Manufacturer
- Haleon US Holdings LLC
- Effective date
- 2024-04-08
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- full-release
- Hydrated at
- 2026-06-01 00:10:49
Label at a glance#
ProductRobitussin Direct Sore Throat Pain
Active ingredientACETAMINOPHEN
Label structure9 sections
Dosage and administration
do not take more than directed adults and children 12 years of age and over: take 1 caplet every 4 hours, or 2 caplets every 6 hours, while symptoms last do not take more than 6 caplets in any 24 hours, unless directed by a doctor do not take for more than 10 days unless directed by a doctor children under 12 years of age: ask a doctor
Contacts and useful links#
Websitewww.robitussin.com
www.robitussin.com
www.robitussin.comLabel contents#
Full prescribing information#
Active ingredient (in each caplet)
Acetaminophen 500 mg
Purposes
Pain reliever/Fever reducer
Uses
- temporarily relieves minor aches and pains due to:
- sore throat
- headache
- backache
- toothache
- premenstrual and menstrual cramps
- the common cold
- minor pain of arthritis
- muscular aches
- temporarily reduces fever
Warnings
Liver warning:
This product contains acetaminophen. Severe liver damage may occur if you take
- more than 4,000 mg of acetaminophen in 24 hours
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
- blisters
- rash
- If a skin reaction occurs, stop use and seek medical help right away.
Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
Do not use
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- if you are allergic to acetaminophen or any of the inactive ingredients in this product
Ask a doctor before use if you have liver disease
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin
Stop use and ask a doctor if
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
- These could be signs of a serious condition.
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
- do not take more than directed
- adults and children 12 years of age and over: take 1 caplet every 4 hours, or 2 caplets every 6 hours, while symptoms last
- do not take more than 6 caplets in any 24 hours, unless directed by a doctor
- do not take for more than 10 days unless directed by a doctor
- children under 12 years of age: ask a doctor
Other information
- store at 25°C (77°F)
Inactive ingredients
castor oil, hypromellose, povidone, pregelatinized starch, sodium starch glycolate, stearic acid
Additional Information
Do not use if safety seal under cap printed with “Sealed for Your Protection” is broken or missing.
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
Lift Here for More Drug Facts
PRINCIPAL DISPLAY PANEL
NEW
Robitussin
Sore Throat Pain
Acetaminophen
(Pain Reliever, Fever Reducer)
direct
18 Caplets
Actual size
L-0630-175-44-UPC_ORG - Front Label
DailyMed RxNorm Mappings#
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0031-9301-01 | Robitussin Direct Sore Throat Pain | 18 in 1 BOTTLE | TABLET, COATED | 18 | 4 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Robitussin Direct Sore Throat Pain
- acetaminophen
- CASTOR OIL
- HYPROMELLOSE, UNSPECIFIED
- POVIDONE, UNSPECIFIED
- STARCH, CORN
- SODIUM STARCH GLYCOLATE TYPE A POTATO
- STEARIC ACID
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0031-9301 | 0031-9301-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| CASTOR OIL | D5340Y2I9G | IACT |
| HYPROMELLOSE, UNSPECIFIED | 3NXW29V3WO | IACT |
| POVIDONE, UNSPECIFIED | FZ989GH94E | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | 5856J3G2A2 | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
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 Direct Sore Throat Pain | ACETAMINOPHEN | Haleon US Holdings LLC | 1b512078-24c3-4b80-8f2c-d6824d367f25 | 2024-04-08 | Warnings | 0031-9301-01 0031-9301 00031930101 159c0477-cdc8-fbc7-e063-6294a90a3448 1b512078-24c3-4b80-8f2c-d6824d367f25 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.