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 • runny nose and sneezing
Daytime Nighttime
- Manufacturer
- CVS Pharmacy
- Effective date
- 2024-12-15
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 20:45:49
Label at a glance#
ProductDaytime Nighttime cold and flu relief
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE
Label structure17 sections
Dosage and administration
• take only as directed – see Overdose warning • only use the dose cup provided • do not exceed 4 doses per 24 hrs adults & children 12 yrs & over 30 mL every 6 hrs children 4 to under 12 yrs ask a doctor children under 4 yrs do not use
Storage and handling
• each 30 mL dose cup contains: sodium 39 mg • store at 20-25 ° C (68-77 ° F)
Contacts and useful links#
Label contents#
Full prescribing information#
Nighttime Cold & FluActive ingredients (in each 30 mL)
Acetaminophen 650 mg
Dextromethorphan HBr 30 mg
Doxylamine succinate 12.5 mg
Purpose
Pain reliever/fever reducer
Cough suppressant
Antihistamine
Uses
temporarily relieves common cold/flu symptoms:
- cough due to minor throat and bronchial irritation
- sore throat
- headache
- minor aches and pains
- fever
- runny nose and sneezing
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
- glaucoma
- cough that occurs with too much phlegm (mucus)
- a breathing problem such as emphysema or chronic bronchitis
- trouble urinating due to an enlarged prostate gland
- persistent or chronic cough as occurs with smoking, asthma, or emphysema sodium-restricted diet
Ask a doctor or pharmacist before use if you are
- taking sedatives or tranquilizers
- taking the blood thinning drug warfarin
When using this product
- excitability may occur, especially in children
- marked drowsiness may occur
- avoid alcoholic drinks
- be careful when driving a motor vehicle or operating machinery
- alcohol, sedatives, and tranquilizers may increase drowsiness
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
- only use the dose cup provided
- do not exceed 4 doses per 24 hrs
adults & children 12 yrs & over | 30 mL every 6 hrs |
children 4 to under 12 yrs | ask a doctor |
children under 4 yrs | do not use |
Other information
- each 30 mL dose cup contains: sodium 39 mg
- store at 20-25°C (68-77°F)
Inactive ingredients
alcohol, anhydrous citric acid, FD&C blue no. 1, FD&C red no. 40, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate
Questions or comments?
1-800-719-9260
Daytime Cold & FluActive ingredients (in each 15 mL)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg
Purpose
Pain reliever/fever reducer
Cough suppressant
Nasal decongestant
Uses
- temporarily relieves common cold/flu symptoms:
- nasal congestion
- 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
- adult takes more than 4,000 mg of acetaminophen in 24 hours
- child takes more than 5 doses in 24 hours
- taken with other drugs containing acetaminophen
- adult has 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
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- trouble urinating due to an enlarged prostate gland
- 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
When using this product
do not use more than directed
Stop use and ask a doctor if
- you get nervous, dizzy or sleepless
- pain, nasal congestion or cough gets worse or lasts more than 5 days (children) or 7 days (adults)
- 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
- only use the dose cup provided
- do not exceed 4 doses per 24 hrs
adults & children 12 yrs & over | 30 mL every 4 hrs |
children 6 to under 12 yrs | 15 mL every 4 hrs |
children 4 to under 6 yrs | ask a doctor |
children under 4 yrs | do not use |
Other information
- each 15 mL contains: sodium 7 mg
- store at 20-25°C (68-77°F)
Inactive ingredients
butylated hydroxyanisole, edetate disodium, FD&C yellow no. 6, flavor, glycerin, menthol, monobasic sodium phosphate, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sucrose, xanthan gum
Questions or comments?
1-800-719-9260
Package/Label Principal Display Panel
COMBO PACK
CVS Health®
Compare to the active ingredients in Vicks® DayQuil® Cold & Flu
CVS Health®
Non-Drowsy
Daytime
ACETAMINOPHEN - Pain reliever; Fever reducer
DEXTROMETHORPHAN HBr - Cough suppressant
PHENYLEPHRINE HCl - Nasal decongestant
Relieves:
Aches, Fever, Sore throat, Cough, Nasal congestion
COLD & FLU
ALCOHOL & ANTIHISTAMINE FREE
TOTAL 24 FL OZ (1.5 PT) (710 mL)
COMBO PACK
CVS Health®
Compare to the active ingredients in Vicks® NyQuil® Cold & Flu
CVS Health®
Multi-Symptom
Nighttime
ACETAMINOPHEN - Pain reliever; Fever reducer
DEXTROMETHORPHAN HBr - Cough suppressant
DOXYLAMINE SUCCINATE - Antihistamine
Relieves:
Aches, Fever, Sore throat, Cough, Sneezing, Runny nose
COLD & FLU
Cherry Flavor
ALCOHOL 10%
TWO 12 FL OZ (355 mL) UNITS
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 69842-733-02 | 2023-11-07 | C162847 | 48780-1 | 0191ceaa-67f8-198a-e063-dbdaa90aec3e | Daytime Nighttime Cold & Flu Relief Drug Facts |
| 69842-733-02 | 2023-07-28 | C162847 | 48780-1 | 0191ceaa-67f8-198a-e063-dbdaa90aec3e | Daytime Nighttime Cold & Flu Relief Drug Facts |
Products#
Every source-derived product name is available through these pages.
- Daytime Nighttime cold and flu relief
- Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl
- Nighttime cold and flu relief
- acetaminophen, dextromethorphan hbr, doxylamine succinate
- ACETAMINOPHEN
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- DOXYLAMINE SUCCINATE
- DOXYLAMINE
- ALCOHOL
- ANHYDROUS CITRIC ACID
- FD&C BLUE NO. 1
- FD&C RED NO. 40
- HIGH FRUCTOSE CORN SYRUP
- POLYETHYLENE GLYCOL, UNSPECIFIED
- PROPYLENE GLYCOL
- WATER
- SACCHARIN SODIUM
- SODIUM CITRATE, UNSPECIFIED FORM
- Daytime cold and flu relief
- acetaminophen, dextromethorphan hbr, phenylephrine hcl
- PHENYLEPHRINE HYDROCHLORIDE
- PHENYLEPHRINE
- BUTYLATED HYDROXYANISOLE
- EDETATE DISODIUM
- FD&C YELLOW NO. 6
- GLYCERIN
- SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM
- SUCROSE
- XANTHAN GUM
- MENTHOL, UNSPECIFIED FORM
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 69842-733 | 69842-733-02 |
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 |
|---|---|---|---|---|---|---|
| 85018a61-07a8-4c79-b699-6463561dd89e | e8fd21a5-d690-474e-946d-18c5fad3fa97 | 2024-12-15 | Warnings | 85018a61-07a8-4c79-b699-6463561dd89e e8fd21a5-d690-474e-946d-18c5fad3fa97 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.