Daytime Cold and Flu
- Manufacturer
- CVS Pharmacy | TIME CAP LABS INC | MARKSANS PHARMA LIMITED
- Effective date
- 2026-03-16
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-06-01 01:50:18
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
Active ingredients (in each softgel)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
OTC - PURPOSE SECTION
Purposes
Pain reliever/fever reducer
Cough suppressant
INDICATIONS & USAGE SECTION
Uses
- temporarily relieves these common cold and flu symptoms:
- 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 12 softgels in 24 hours, which is the maximum daily amount for this product
- 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 right away (1-800-222-1222). 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 12 softgels in any 24-hour period
- adults and children 12 years of age and over: take 2 softgels every 4 hours
- children under 12 years of age: do not use
OTHER SAFETY INFORMATION
Other information
- store at 20-25°C (68-77°F)
- avoid excessive heat
INACTIVE INGREDIENT SECTION
Inactive ingredients
FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide
OTC - QUESTIONS SECTION
Questions or comments? Call 1-877-290-4008
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
CVS 798T
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1867684 | acetaminophen 325 MG / dextromethorphan HBr 10 MG Oral Capsule | PSN | 2 |
| 1867684 | acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG Oral Capsule | SCD | 2 |
| 1867684 | acetaminophen 325 MG / dextromethorphan HBr 10 MG Oral Capsule | SY | 2 |
| 1867684 | APAP 325 MG / Dextromethorphan Hydrobromide 10 MG Oral Capsule | 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 |
|---|---|---|---|---|---|---|
| 51316-897-16 | Daytime Cold and Flu | 8 in 1 BLISTER PACK | CAPSULE, LIQUID FILLED | 8 | 2 | |
| 51316-897-16 | Daytime Cold and Flu | 2 in 1 CARTON | CAPSULE, LIQUID FILLED | 2 | 2 |
Products#
Every source-derived product name is available through these pages.
- Daytime Cold and Flu
- Acetaminophen, Dextromethorphan HBr
- WATER
- GELATIN, UNSPECIFIED
- POVIDONE, UNSPECIFIED
- GLYCERIN
- FD&C YELLOW NO. 6
- PROPYLENE GLYCOL
- SORBITAN
- FD&C RED NO. 40
- TITANIUM DIOXIDE
- ACETAMINOPHEN
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- SHELLAC
- POLYETHYLENE GLYCOL, UNSPECIFIED
- SORBITOL SOLUTION
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 51316-897 | 51316-897-16 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| WATER | 059QF0KO0R | IACT |
| GELATIN, UNSPECIFIED | 2G86QN327L | IACT |
| POVIDONE, UNSPECIFIED | FZ989GH94E | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| FD&C YELLOW NO. 6 | H77VEI93A8 | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| SORBITAN | 6O92ICV9RU | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| SHELLAC | 46N107B71O | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| SORBITOL SOLUTION | 8KW3E207O2 | IACT |
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 1 | 2026-01-13 | monthly-update | 2026-06-03 17:56:11 |
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 |
|---|---|---|---|---|---|---|
| Daytime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR | CVS Pharmacy | 48438525-e49f-9303-e063-6394a90a44f2 | 2026-03-16 | Warnings | 51316-897-16 51316-897 51316089716 4d1f15a3-53f6-02c5-e063-6294a90ae190 48438525-e49f-9303-e063-6394a90a44f2 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
