Indications and uses
DAY COLD & FLU FORMULA temporarily relieves these symptoms due to a cold or flu: minor aches and pains headache cough sore throat nasal and sinus congestion temporarily reduces fever
CVS Health DAY Cold and Flu Plus
- Manufacturer
- CVS Pharmacy
- Effective date
- 2022-11-18
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 5
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 21:47:32
Label at a glance#
ProductCVS Health Non Drowsy DAY Cold and Flu Plus and NIGHTTIME Cold and Flu Plus
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE
Label structure17 sections
Dosage and administration
do not take more than the recommended dose adults and children 12 years and over: take 2 softgels with water every 4 hours. Do not exceed 10 softgels in 24 hours or as directed by a doctor. children under 12 years: do not use
Storage and handling
store at room temperature. Avoid excessive heat.
Contacts and useful links#
Label contents#
Full prescribing information#
CVS Health COLD & FLU FORMULA DAY NON-DROWSY Active ingredients (in each softgel)
Acetaminophen 325 mg
Dextromethorphan hydrobromide 10 mg
Phenylephrine hydrochloride 5 mg
CVS Health COLD & FLU FORMULA NIGHT Active ingredients (in each softgel)
Acetaminophen 325 mg
Dextromethorphan hydrobromide 10 mg
Doxylamine succinate 6.25 mg
Phenylephrine hydrochloride 5 mg
Purposes
DAY COLD & FLU FORMULA
Pain reliever/fever reducer
Cough suppressant
Nasal decongestant
Purposes
NIGHT COLD & FLU FORMULA
Pain reliever/fever reducer
Cough suppressant
Antihistamine
Nasal decongestant
Uses
DAY COLD & FLU FORMULA
- temporarily relieves these symptoms due to a cold or flu:
- minor aches and pains
- headache
- cough
- sore throat
- nasal and sinus congestion
- temporarily reduces fever
Uses
NIGHT COLD & FLU FORMULA
- temporarily relieves these symptoms due to a cold or flu:
- minor aches and pains
- headache
- nasal and sinus congestion
- cough
- sore throat
- runny nose
- sneezing
- temporarily reduces fever
DAY COLD & FLU FORMULA Warnings
Liver warning
These products contain acetaminophen. Severe liver damage may occur if you take
- more than 10 softgels in 24 hours, which is the maximum daily amount for this product
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
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.
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.
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
- in children under 12 years of age
Ask a doctor before use if you have
- liver disease
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- cough with excessive phlegm (mucus)
- difficulty in urination due to enlargement of the prostate gland
- persistent or chronic cough such as occurs with smoking, asthma, or emphysema
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 exceed recommended dosage
Stop use and ask a doctor if
- pain, cough, or nasal congestion 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.
- nervousness, dizziness, or sleeplessness occurs
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
NIGHTTIME COLD & FLU FORMULA Warnings
Liver warning
These products contain acetaminophen. Severe liver damage may occur if you take
- more than 10 softgels in 24 hours, which is the maximum daily amount for this product
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
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.
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.
Do not use to sedate children.
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
- in children under 12 years of age
Ask a doctor before use if you have
- liver disease
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- glaucoma
- cough with excessive phlegm (mucus)
- a breathing problem such as emphysema or chronic bronchitis
- difficulty in urination due to enlargement of the prostate gland
- 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
- taking sedatives or tranquilizers
When using this product
- do not exceed recommended dosage
- may cause marked drowsiness
- avoid alcoholic drinks
- alcohol, sedatives, and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
- excitability may occur, especially in children
Stop use and ask a doctor if
- pain, cough, or nasal congestion 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.
- nervousness, dizziness, or sleeplessness occurs
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
DAY COLD & FLU FORMULA Directions
- do not take more than the recommended dose
- adults and children 12 years and over: take 2 softgels with water every 4 hours. Do not exceed 10 softgels in 24 hours or as directed by a doctor.
- children under 12 years: do not use
NIGHTTIME COLD & FLU FORMULA Directions
- do not take more than the recommended dose
- adults and children 12 years and over: take 2 softgels with water every 4 hours. Do not exceed 10 softgels in 24 hours or as directed by a doctor.
- children under 12 years: do not use
DAY COLD & FLU FORMULA Other information
- store at room temperature. Avoid excessive heat.
NIGHTTIME COLD & FLU FORMULA Other information
- store at room temperature. Avoid excessive heat.
DAY COLD & FLU FORMULA Inactive ingredients
FD&C Red No. 40, FD&C Yellow No. 6, gelatin, glycerin, polyethylene
glycol-400, povidone, propylene glycol, purified water, sorbitol sorbitan,
titanium dioxide
NIGHTTIME COLD & FLU FORMULA Inactive ingredients
D&C Yellow No. 10, FD&C Blue No. 1, gelatin, glycerin, polyethylene
glycol-400, povidone, propylene glycol, purified water, shellac, sorbitol
sorbitan, sodium hydroxide, titanium dioxide
DAY COLD & FLU FORMULA
Questions or comments?1-888-333-9792
NIGHTTIME COLD & FLU FORMULA
Questions or comments?1-888-333-9792
Principal Display Panel
CVS NON-DROWSY DAY Cold & Flu Plus and NIGHTTIME Cold & Flu Plus 20ct
Compare to the active ingredients in
Alka-Seltzer PLUS® Day and Night Cold and Flu Formula
NON-DROWSY DAY
Cold & Flu Plus
ACETAMINOPHEN- Pain reliever; Fever reducer
DEXTROMETHORPHAN HBr - Cough suppressant
PHENYLEPHRINE HCI - Nasal decongestant
Relieves:
Nasal congestion; Cough;
Headache & body ache;
Sore throat; Sinus pressure
12 SOFTGELS
NIGHTTIME
Cold & Flu Plus
ACETAMINOPHEN- Pain reliever; Fever reducer
DEXTROMETHORPHAN HBr - Cough suppressant
DOXYLAMINE SUCCINATE - Antihistamine
PHENYLEPHRINE HCI - Nasal decongestant
Relieves:
Nasal congestion; Cough;
Headache & body ache;
Sore throat; Runny nose
8 SOFTGELS
THIS PRODUCT IS PACKAGED IN A CHILD-RESISTANT AND
TAMPER-EVIDENT PACKAGE. USE ONLY IF BLISTERS ARE INTACT
*This product is not manufactured or distributed by Bayer
Healthcare LLC, owner of the registered trademark
Alka-Seltzer PLUS® Day and Night Cold and Flu Formula
Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2019 CVS/pharmacy
CVS.com® 1-800-SHOP CVS
Made in India
V-35249
Products#
Every source-derived product name is available through these pages.
- CVS Health Non Drowsy DAY Cold and Flu Plus and NIGHTTIME Cold and Flu Plus
- acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride
- CVS Health DAY Cold and Flu Plus
- acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride
- FD&C RED NO. 40
- FD&C YELLOW NO. 6
- GELATIN
- GLYCERIN
- POLYETHYLENE GLYCOL 400
- POVIDONE
- PROPYLENE GLYCOL
- WATER
- SORBITOL
- TITANIUM DIOXIDE
- ACETAMINOPHEN
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- PHENYLEPHRINE HYDROCHLORIDE
- PHENYLEPHRINE
- CVS Health NIGHTTIME Cold and Flu Plus
- D&C YELLOW NO. 10
- FD&C BLUE NO. 1
- SHELLAC
- SODIUM HYDROXIDE
- DOXYLAMINE SUCCINATE
- DOXYLAMINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 69842-517 | 69842-517-20 |
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 |
|---|---|---|---|---|---|---|
| 297e1137-40b9-b4e2-e063-6294a90aa920 | dc527a11-fbac-445a-ac32-bb7b180f48bf | 2024-12-17 | Warnings | dc527a11-fbac-445a-ac32-bb7b180f48bf |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.