Indications and uses
• temporarily relieves common cold/flu symptoms: • cough due to minor throat and bronchial irritation • sore throat • headache • minor aches and pains • fever
CVS Pharmacy, Inc. Daytime Cold & Flu Drug Facts
- Manufacturer
- CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
- Effective date
- 2026-06-22
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- monthly-update
- Hydrated at
- 2026-07-17 21:35:46
Label at a glance#
ProductDAYTIME COLD AND FLU
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE
Label structure8 sections
Dosage and administration
• take only as directed - see overdose warning • do not exceed 8 caplets per 24 hrs adults & children 12 yrs & over 2 caplets with water every 4 hrs children 4 to under 12 yrs ask a doctor children under 4 yrs do not use
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredients (in each caplet)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Purpose
Pain reliever/fever reducer
Cough suppressant
Uses
- temporarily relieves common cold/flu symptoms:
- cough due to minor throat and bronchial irritation
- sore throat
- headache
- minor aches and pains
- 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 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.
- if you have ever had an allergic reaction to this product or any of its ingredients
Ask a doctor before use if you have
- liver disease
- cough that occurs with too much phlegm (mucus)
- persistent or chronic cough such as occurs with smoking, asthma, or emphysema
Ask a doctor or pharmacist before use if you are
taking the blood thinning drug warfarin
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.
If pregnant or breast-feeding,
ask a health professional before use.
Keep out of reach of children.
Overdose warning: 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.
Directions
- take only as directed - see overdose warning
- do not exceed 8 caplets per 24 hrs
adults & children 12 yrs & over | 2 caplets with water every 4 hrs |
children 4 to under 12 yrs | ask a doctor |
children under 4 yrs | do not use |
Inactive ingredients
colloidal silicon dioxide, croscarmellose sodium, crospovidone, FD&C yellow #6 aluminum lake, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol 3350, polyvinyl alcohol, povidone, pregelatinized starch, propylene glycol, stearic acid, sucralose, talc, titanium dioxide
Questions or comments?
1-800-719-9260
Package/Label Principal Display Panel
NEW FORMULA
CVS™
COOLING
actual size
DAYTIME COLD & FLU
Acetaminophen
Pain Reliever / Fever Reducer
Dextromethorphan HBr
Cough Suppressant
Compare to Vicks® DayQuil® VapoCOOL® active ingredients
Relieves: Headache, Fever, Sore throat, Minor aches & pains, Cough
24 CAPLETS
Products#
Every source-derived product name is available through these pages.
- DAYTIME COLD AND FLU
- acetaminophen, dextromethorphan hydrobromide
- ACETAMINOPHEN
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- SILICON DIOXIDE
- CROSCARMELLOSE SODIUM
- CROSPOVIDONE, UNSPECIFIED
- FD&C YELLOW NO. 6 ALUMINUM LAKE
- MAGNESIUM STEARATE
- MICROCRYSTALLINE CELLULOSE
- POLYETHYLENE GLYCOL 3350
- POLYVINYL ALCOHOL, UNSPECIFIED
- POVIDONE, UNSPECIFIED
- PROPYLENE GLYCOL
- STEARIC ACID
- SUCRALOSE
- TALC
- TITANIUM DIOXIDE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 51316-676 | 51316-676-62 |
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 |
|---|---|---|---|---|---|---|
| DAYTIME COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 59db2573-7ebb-4cf9-bfe3-428929bb4eeb | 2026-06-22 | Warnings | 51316-676-62 51316-676 51316067662 737aafe1-dd7e-487d-b474-60be1ea33aac 59db2573-7ebb-4cf9-bfe3-428929bb4eeb |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.