Ultra concentrated Daytime/ Nighttime Severe Softgel
- Manufacturer
- CVS PHARMACY, INC | TIME CAP LABORATORIES, INC. | MARKSANS PHARMA LIMITED
- Effective date
- 2026-03-26
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- full-release
- Hydrated at
- 2026-06-01 01:51:32
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Drug Facts
Active ingredients (in each softgel)
Acetaminophen 325 mg
Dextromethorphan hydrobromide 10 mg
Phenylephrine hydrochloride 5 mg
OTC - PURPOSE SECTION
Purposes
Pain reliever/fever reducer
Cough suppressant
Nasal decongestant
INDICATIONS & USAGE SECTION
Uses
- temporarily relieves these symptoms due to a cold or flu:
- minor aches and pains
- headache
- nasal congestion
- sore throat
- sinus congestion and pressure
- cough
- temporarily reduces fever
WARNINGS SECTION
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 or severe allergic reactions. Symptoms may include:
- skin reddening
- blisters
- rash
- hives
- facial swelling
- asthma (wheezing)
- shock
If a skin or general allergic 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.
- if you have ever had an allergic reaction to this product or any of its ingredients
- in children under 12 years of age
OTC - ASK DOCTOR SECTION
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
OTC - STOP USE SECTION
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.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children. 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 the recommended dose
- do not take the Day and Night products at the same time; wait 4 hours after the last Night dose before starting Day product.
- adults and children 12 years and over: take 2 softgels with water every 4 hours. Do not exceed 6 softgels in 12 hours or as directed by a doctor.
- children under 12 years: do not use
OTHER SAFETY INFORMATION
Other information
store at no greater than 25°C
INACTIVE INGREDIENT SECTION
Inactive ingredients FD&C yellow no. 6 al. lake, gelatin, glycerin, mica, polyethylene glycol 400, povidone, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide
OTC - QUESTIONS SECTION
Questions or comments? Call 1-877-290-4008
OTC - ACTIVE INGREDIENT SECTION
Active ingredients (in each softgel)
Acetaminophen 325 mg
Dextromethorphan hydrobromide 10 mg
Doxylamine succinate 6.25 mg
Phenylephrine hydrochloride 5 mg
OTC - PURPOSE SECTION
Purposes
Pain reliever/fever reducer
Cough suppressant
Antihistamine
Nasal decongestant
INDICATIONS & USAGE SECTION
Uses
- temporarily relieves these symptoms due to a cold or flu:
- minor aches and pains
- headache
- nasal congestion
- cough
- sinus congestion and pressure
- runny nose
- sore throat
- sneezing
- temporarily reduces fever
WARNINGS SECTION
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 or severe allergic reactions. Symptoms may include:
- skin reddening
- blisters
- rash
- hives
- facial swelling
- asthma (wheezing)
- shock
If a skin or general allergic 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 to sedate children.
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.
- if you have ever had an allergic reaction to this product or any of its ingredients
- in children under 12 years of age
OTC - ASK DOCTOR SECTION
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
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if you are
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers
OTC - WHEN USING SECTION
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
OTC - STOP USE SECTION
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.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children. 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 the recommended dose
- do not take the Day and Night products at the same time; wait 4 hours after the last Day dose before starting Night product.
- adults and children 12 years and over: take 2 softgels with water every 4 hours. Do not exceed 4 softgels in 12 hours or as directed by a doctor.
- children under 12 years: do not use
OTHER SAFETY INFORMATION
Other information
- store at no greater than 25°C
INACTIVE INGREDIENT SECTION
Inactive ingredients D&C yellow no. 10 al. lake, FD&C blue no.1 al. lake, gelatin, glycerin, mica, polyethylene glycol 400, povidone, purified water, shellac, sorbitol sorbitan solution, titanium dioxide
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 |
|---|---|---|---|
| 2634363 | {1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG / phenylephrine hydrochloride 5 MG Oral Capsule) / 1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule) } Pack | GPCK | 3 |
| 2634363 | 1 daytime (acetaminophen 325 MG / dextromethorphan Hbr 10 MG / phenylephrine HCl 5 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral Capsule) Pack | PSN | 3 |
| 1297288 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral Capsule | PSN | 3 |
| 1086997 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Capsule | PSN | 3 |
| 1297288 | acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG / phenylephrine hydrochloride 5 MG Oral Capsule | SCD | 3 |
| 1086997 | acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule | SCD | 3 |
| 2634363 | 1 daytime (acetaminophen 325 MG / dextromethorphan Hbr 10 MG / phenylephrine HCl 5 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral Capsule) Pack | SY | 3 |
| 1297288 | APAP 325 MG / Dextromethorphan Hydrobromide 10 MG / doxylamine succinate 6.25 MG / Phenylephrine Hydrochloride 5 MG Oral Capsule | SY | 3 |
| 1086997 | APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule | SY | 3 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| DEXTROMETHORPHAN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| DOXYLAMINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| PHENYLEPHRINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 51316-547-24 | Ultra concentrated Daytime/ Nighttime Severe Softgel | 2 in 1 CARTON | KIT | 2 | 3 | |
| 51316-547-24 | Ultra concentrated Daytime/ Nighttime Severe Softgel | 1 in 1 BLISTER PACK | KIT | 1 | 3 |
Products#
Every source-derived product name is available through these pages.
- Ultra concentrated Daytime/ Nighttime Severe Softgel
- Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine hydrochloride softgel
- Daytime Ultra Concentrated
- Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl softgel
- PHENYLEPHRINE HYDROCHLORIDE
- PHENYLEPHRINE
- PROPYLENE GLYCOL
- SORBITAN
- MICA
- POLYETHYLENE GLYCOL, UNSPECIFIED
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- FD&C YELLOW NO. 6 ALUMINUM LAKE
- GLYCERIN
- ACETAMINOPHEN
- WATER
- SHELLAC
- GELATIN
- POVIDONE
- TITANIUM DIOXIDE
- Nighttime Severe Ultra Concentrated
- Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl softgel
- D&C YELLOW NO. 10 ALUMINUM LAKE
- FD&C BLUE NO. 1 ALUMINUM LAKE
- DOXYLAMINE SUCCINATE
- DOXYLAMINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 51316-547 | 51316-547-24 |
| 51316-577 | |
| 51316-446 |
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 |
|---|---|---|---|---|---|---|
| Ultra concentrated Daytime/ Nighttime Severe Softgel | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE SOFTGEL | CVS PHARMACY, INC | 24cedaec-06a6-8fde-e063-6394a90a3d7a | 2026-03-26 | Warnings | 51316-547-24 51316-547 51316054724 4de9aabc-fafa-fd37-e063-6294a90ab10c 24cedaec-06a6-8fde-e063-6394a90a3d7a |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
