Daytime Nighttime Cold and Flu
- Manufacturer
- WALGREENS | TIME CAP LABORATORIES, INC. | MARKSANS PHARMA LIMITED
- Effective date
- 2024-03-19
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 5
- Source
- full-release
- Hydrated at
- 2026-06-01 00:09:58
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Daytime Cold & Flu
Active ingredients (in each softgel)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg
Nighttime Cold & Flu
Active ingredients (in each softgel)
Acetaminophen 325 mg
Dextromethorphan HBr 15 mg
Doxylamine succinate 6.25 mg
OTC - PURPOSE SECTION
Daytime Cold & Flu
Purpose
Pain reliever/fever reducer
Cough suppressant
Nasal decongestant
Nighttime Cold & Flu
Purpose
Pain reliever/fever reducer
Cough suppressant
Antihistamine
INDICATIONS & USAGE SECTION
Uses
temporarily relieves common cold/flu symptoms:
- nasal congestion (Daytime only)
- cough due to minor throat & bronchial irritation
- sore throat
- headache
- minor aches and pains
- fever
- runny nose and sneezing (Nighttime only)
WARNINGS SECTION
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 4 doses in 24 hrs, which is the maximum daily amount for this product
- wilh 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.
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
- heart disease (Daytime only)
- high blood pressure (Daytime only)
- thyroid disease (Daytime only)
- diabetes (Daytime only)
- trouble urinating due to enlarged prostate gland
- cough that occurs with too much phlegm (mucus)
- persistent or chronic cough as occurs with smoking, asthma, or emphysema (Daytime only)
- glaucoma (Nighttime only)
- a breathing problem or chronic cough that lasts or as occurs with smoking, asthma,chronic bronchitis or emphysema (Nighttime only)
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 (Nighttime only)
OTC - WHEN USING SECTION
When using this product
- do not use more than directed (Daytime only)
- excitability may occur, especially in children (Nighttime only)
- marked drowsiness may occur (Nighttime only)
- avoid alcoholic drinks (Nighttime only)
- be careful when driving a motor vehicle or operating machinery (Nighttime only)
- alcohol, sedatives, & tranquilizers may increase drowsiness (Nighttime only)
OTC - STOP USE SECTION
Stop use and ask a doctor If
- you get nervous, dizzy or sleepless (Daytime only)
- pain, nasal congestion or cough get worse or last more than 7days (Daytime only)
- 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.
- pain, or cough gets worse or lasts more than 7days (Nighttime only)
- 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.
In case of overdose, get medical help or contact a Poison Control Center righl away (1-800-222-1222). Quick medical attention is critical for adults & for children even if you do not notice any signs or symptoms.
DOSAGE & ADMINISTRATION SECTION
Directions
- take only as directed
- do not exceed 4 doses per 24 hrs
adults & children 12yrs & over: 2 softgels with water every 6 hrs(Nighttime only)
2 softgels with water every 4 hrs (Daytime only)
children 4 to under 12 yrs: ask a doctor
children under 4 yrs: do not use
OTHER INFORMATION
Other information
- store at room temperature
INACTIVE INGREDIENT SECTION
Inactive ingredients (Daytime only)
FD&C red # 40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide.
Inactive ingredients (Nighttime only)
FD&C blue #1, FD&C yellow #10, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide.
OTC - QUESTIONS SECTION
Questions? Call 1-877-290-4008
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 2634564 | {1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule) / 1 (acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule) } Pack | GPCK | 5 |
| 2634564 | 1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule) Pack | PSN | 5 |
| 1086997 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Capsule | PSN | 5 |
| 1094549 | acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule | PSN | 5 |
| 1086997 | acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule | SCD | 5 |
| 1094549 | acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule | SCD | 5 |
| 2634564 | 1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule) Pack | SY | 5 |
| 1086997 | APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule | SY | 5 |
| 1094549 | APAP 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule | SY | 5 |
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#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 59361619-24d9-b610-eca6-5a7f25ed5e03 | Product name | 5 | 20240909 |
| f4368033-af8c-41bf-a84b-ff77392b8522 | Product name | 1 | 20161229 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0363-0729-24 | Daytime Nighttime Cold and Flu | 1 in 1 BLISTER PACK | KIT | 1 | 5 | |
| 0363-0729-24 | Daytime Nighttime Cold and Flu | 2 in 1 CARTON | KIT | 2 | 5 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0363-0729 | DAYTIME NIGHTTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) KIT [WALGREENS] | 5 | Current NDC, Legacy NDC, 2 package rows | 20240320_c945c35e-de0d-0fd6-e053-2995a90a1fbf.zip |
Products#
Every source-derived product name is available through these pages.
- Daytime Nighttime Cold and Flu
- Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl and Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate
- DAYTIME COLD AND FLU
- acetaminophine dextromethorphan hbr phenylphrine hcl
- FD&C RED NO. 40
- POLYETHYLENE GLYCOL, UNSPECIFIED
- POVIDONE
- SORBITAN
- TITANIUM DIOXIDE
- ACETAMINOPHEN
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- FD&C YELLOW NO. 6
- PHENYLEPHRINE HYDROCHLORIDE
- PHENYLEPHRINE
- SHELLAC
- WATER
- GELATIN
- GLYCERIN
- PROPYLENE GLYCOL
- NIGHTTIME COLD AND FLU
- acetaminophen dextromethorphan hbr doxylamine succinate
- FD&C BLUE NO. 1
- DOXYLAMINE SUCCINATE
- DOXYLAMINE
- D&C YELLOW NO. 10
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0363-0729 | 0363-0729-24 |
| 0363-0853 | |
| 0363-0850 |
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 Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | WALGREENS | c945c35e-de0d-0fd6-e053-2995a90a1fbf | 2024-03-19 | Warnings | 0363-0729-24 0363-0729 00363072924 f17043d3-c930-e6b9-e053-2995a90af141 c945c35e-de0d-0fd6-e053-2995a90a1fbf |
| Nighttime Cold and Flu | ACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATE | WALGREENS | d3053f80-aece-eb50-e053-2a95a90a5945 | 2024-03-15 | Warnings | 0363-0850 |
| Daytime Cold and Flu | ACETAMINOPHINE DEXTROMETHORPHAN HBR PHENYLPHRINE HCL | WALGREENS | d315bc95-1b46-75df-e053-2a95a90a6c66 | 2024-03-15 | Warnings | 0363-0853 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
