Cough and Sore Throat
- Manufacturer
- CVS | TIME CAP LABORATORIES, INC. | MARKSANS PHARMA LIMITED
- Effective date
- 2025-05-02
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-06-01 01:00:13
Label at a glance#
ProductCough and Sore Throat
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE
Label structure10 sections
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
Active ingredients (in each 20 mL)
Acetaminophen 650 mg
Dextromethorphan HBr 20 mg
OTC - PURPOSE SECTION
Purposes
Pain reliever/fever reducer
Cough suppressant
INDICATIONS & USAGE SECTION
Uses
- temporarily relieves:
- cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
- the intensity of coughing
- the impulse to cough to help you get to sleep
- minor aches and pains
- sore throat
- headache
- temporarily reduces fever
WARNINGS SECTION
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 6 doses in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks daily 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.
OTC - DO NOT USE SECTION
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 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.
OTC - ASK DOCTOR SECTION
Ask a doctor before use if you have
- liver disease
- persistent or chronic cough such as occurs with smoking, asthma, or emphysema
- cough that occurs with too much phlegm (mucus)
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin
OTC - WHEN USING SECTION
When using this product do not use more than directed
OTC - STOP USE SECTION
Stop use and ask a doctor if
- pain or cough gets worse or lasts more than 7 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
- cough comes back or occurs with rash or headache that lasts. 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.
Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
DOSAGE & ADMINISTRATION SECTION
Directions
- do not take more than directed (see Overdose warning)
- do not take more than 6 doses in any 24-hour period
- measure only with dosing cup provided
- do not use dosing cup with other products
- dose as follows or as directed by a doctor
- adults and children 12 years of age and over: 20 mL in dosing cup provided every 4 hours
- children under 12 years of age: do not use
OTHER SAFETY INFORMATION
Other information
- each 20 mL contains: sodium 17 mg
- store at 20-25°C (68-77°F) and do not refrigerate.
INACTIVE INGREDIENT SECTION
Inactive ingredients
citric acid anhydrous, D&C yellow no. 10, edetate disodium, FD&C red no. 40, flavors, glycerin, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium saccharin, sorbitol solution, sucralose, xanthan gum
OTC - QUESTIONS SECTION
Questions or comments? Call 1-877-290-4008
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1919076 | acetaminophen 325 MG / dextromethorphan HBr 10 MG in 10 mL Oral Solution | PSN | 2 |
| 1919076 | acetaminophen 32.5 MG/ML / dextromethorphan hydrobromide 1 MG/ML Oral Solution | SCD | 2 |
| 1919076 | acetaminophen 325 MG / dextromethorphan HBr 10 MG per 10 mL Oral Solution | SY | 2 |
| 1919076 | acetaminophen 650 MG / dextromethorphan HBr 20 MG per 20 mL Oral Solution | SY | 2 |
| 1919076 | APAP 32.5 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML Oral Solution | SY | 2 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| DEXTROMETHORPHAN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 51316-662-03 | Cough and Sore Throat | 180 mL in 1 BOTTLE | LIQUID | 180 | 2 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Cough and Sore Throat
- Acetaminophen, Dextromethorphan Hydrobromide liquid
- D&C YELLOW NO. 10
- FD&C RED NO. 40
- GLYCERIN
- PROPYLENE GLYCOL
- WATER
- SODIUM BENZOATE
- XANTHAN GUM
- ACETAMINOPHEN
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- POLYETHYLENE GLYCOL, UNSPECIFIED
- SUCRALOSE
- SODIUM SACCHARIN
- SODIUM CITRATE
- SORBITOL SOLUTION
- ANHYDROUS CITRIC ACID
- EDETATE DISODIUM
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 51316-662 | 51316-662-03 |
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 |
|---|---|---|---|---|---|---|
| Cough and Sore Throat | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE LIQUID | CVS | 2d13564a-e8d1-c357-e063-6394a90ad90e | 2025-05-02 | Warnings | 51316-662-03 51316-662 51316066203 3161682c-7349-d0ce-e063-6294a90ad18c 2d13564a-e8d1-c357-e063-6394a90ad90e |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.