Active Ingredients And Purpose
Active ingredients (in each 20 mL)
Acetaminophen, 650 mg Dextromethorphan HBr, 20 mg
Purposes
Pain reliever/Fever reducer Cough suppressant
Robitussin Maximum Strength Severe Cough Plus Sore Throat
- Manufacturer
- Haleon US Holdings LLC
- Effective date
- 2025-11-13
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 11
- Source
- full-release
- Hydrated at
- 2026-06-01 01:16:07
Key Label Information#
Uses
Uses
temporarily relieves these symptoms occurring with a cold or flu: cough due to minor throat and bronchial irritation minor aches and pains sore throat pain headache temporarily reduces fever
Warnings
Warnings
Directions And Dosage
Directions
do not take more than 6 doses in any 24-hour period do not exceed recommended dosage. Taking more than the recommended dose (overdose) may cause serious liver damage. measure only with dosing cup provided keep dosing cup with product mL = milliliter this adult product is not intended for use in children under 12 years of age age dose adults and children 12 years and over 20 mL every 4 hours children under 12 years do not use
Other Label Information
Other information
each 20 mL contains: sodium 13 mg store at 20-25°C (68-77°F). Do not refrigerate.
Inactive ingredients
anhydrous citric acid, FD&C red no. 40, glycerin, menthol, natural & artificial flavor, polyethylene glycol, polysorbate 80, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose, xanthan gum
Questions or comments?
call weekdays from 8 AM to 6 PM EST at 1-800-245-1040
PRINCIPAL DISPLAY PANEL
ADULT Robitussin MAXIMUM STRENGTH SEVERE Cough + Sore Throat ACETAMINOPHEN (Pain Reliever/Fever Reducer) DEXTROMETHORPHAN HBr (Cough Suppressant) Relieves: Cough Sore Throat Pain Strong Cooling Liquid Non-Drowsy POWERFUL SORE THROAT Relief CF MAX For Ages 12 & Over 4 FL OZ (118 mL)
Label Images#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1919076 | acetaminophen 325 MG / dextromethorphan HBr 10 MG in 10 mL Oral Solution | PSN | 11 |
| 1919076 | acetaminophen 32.5 MG/ML / dextromethorphan hydrobromide 1 MG/ML Oral Solution | SCD | 11 |
| 1919076 | acetaminophen 325 MG / dextromethorphan HBr 10 MG per 10 mL Oral Solution | SY | 11 |
| 1919076 | acetaminophen 650 MG / dextromethorphan HBr 20 MG per 20 mL Oral Solution | SY | 11 |
| 1919076 | APAP 32.5 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML Oral Solution | SY | 11 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| DEXTROMETHORPHAN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
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 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0031-8750-12 | Robitussin Maximum Strength Severe Cough Plus Sore Throat | 118 mL in 1 BOTTLE | LIQUID | 118 | 11 | |
| 0031-8750-12 | Robitussin Maximum Strength Severe Cough Plus Sore Throat | 1 in 1 CARTON | LIQUID | 1 | 11 | |
| 0031-8750-18 | Robitussin Maximum Strength Severe Cough Plus Sore Throat | 1 in 1 CARTON | LIQUID | 1 | 11 | |
| 0031-8750-18 | Robitussin Maximum Strength Severe Cough Plus Sore Throat | 237 mL in 1 BOTTLE | LIQUID | 237 | 11 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0031-8750-12 | ML - Milliliter | 0031-8750 | 999c0b22-960e-42da-9a18-a0948763bc9e | 1 | 2020-05-08 |
| 0031-8750-18 | ML - Milliliter | 0031-8750 | cf497560-869d-468f-ad8a-e65a1bb6460e | 1 | 2020-06-05 |
Products#
- Robitussin Maximum Strength Severe Cough Plus Sore Throat
- acetaminophen, dextromethorphan hydrobromide
- DEXTROMETHORPHAN
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0031-8750 | 0031-8750-12, 0031-8750-18 |
Ingredients#
Complete SPL Sections#
Active ingredients (in each 20 mL)
Acetaminophen, 650 mg Dextromethorphan HBr, 20 mg
Purposes
Pain reliever/Fever reducer Cough suppressant
Uses
temporarily relieves these symptoms occurring with a cold or flu: cough due to minor throat and bronchial irritation minor aches and pains sore throat pain headache temporarily reduces fever
Warnings
Directions
do not take more than 6 doses in any 24-hour period do not exceed recommended dosage. Taking more than the recommended dose (overdose) may cause serious liver damage. measure only with dosing cup provided keep dosing cup with product mL = milliliter this adult product is not intended for use in children under 12 years of age age dose adults and children 12 years and over 20 mL every 4 hours children under 12 years do not use
Other information
each 20 mL contains: sodium 13 mg store at 20-25°C (68-77°F). Do not refrigerate.
Inactive ingredients
anhydrous citric acid, FD&C red no. 40, glycerin, menthol, natural & artificial flavor, polyethylene glycol, polysorbate 80, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose, xanthan gum
Questions or comments?
call weekdays from 8 AM to 6 PM EST at 1-800-245-1040
SPL UNCLASSIFIED SECTION
Dist. by: GSK CH, Warren, NJ 07059 For most recent product information, visit www.robitussin.com Trademarks owned or licensed by GSK ©2022 GSK or licensor Made in Mexico 000065356 Front Carton
PRINCIPAL DISPLAY PANEL
ADULT Robitussin MAXIMUM STRENGTH SEVERE Cough + Sore Throat ACETAMINOPHEN (Pain Reliever/Fever Reducer) DEXTROMETHORPHAN HBr (Cough Suppressant) Relieves: Cough Sore Throat Pain Strong Cooling Liquid Non-Drowsy POWERFUL SORE THROAT Relief CF MAX For Ages 12 & Over 4 FL OZ (118 mL)