Nighttime Ultra Concentrated Cold and Flu
- Manufacturer
- WALGREENS | TIME CAP LABORATORIES, INC. | MARKSANS PHARMA LIMITED
- Effective date
- 2025-04-03
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-06-01 01:06:01
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
Drug Facts
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
Active ingredients (in each softgel)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Doxylamine succinate 6.25 mg
OTC - PURPOSE SECTION
Purpose
Pain reliever/fever reducer
Cough suppressant
Antihistamine
INDICATIONS & USAGE SECTION
Uses
temporarily relieves common cold/flu symptoms:
- cough due to minor throat & bronchial irritation
- sore throat
- headache
- minor aches & pains
- fever
- runny nose & sneezing
WARNINGS SECTION
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- more than 8 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
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.
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
- glaucoma
- cough that occurs with too much phlegm (mucus)
- a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema
- trouble urinating due to enlarged prostate gland
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if you are
- taking sedatives or tranquilizers
- taking the blood thinning drug warfarin
OTC - WHEN USING SECTION
When using this product
- do not use more than directed
- 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
OTC - STOP USE SECTION
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.
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
- take only as directed
- do not exceed 8 softgels per 24 hrs
| adults & children 12 yrs & over | 2 softgels with water every 4 hrs |
| children 4 to under 12 yrs | ask a doctor |
| children under 4 yrs | 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, propylene glycol, 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 |
|---|---|---|---|
| 1426334 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG Oral Capsule | PSN | 2 |
| 1426334 | acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG Oral Capsule | SCD | 2 |
| 1426334 | APAP 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG Oral Capsule | SY | 2 |
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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0363-1756-78 | Nighttime Ultra Concentrated Cold and Flu | 48 in 1 BOTTLE | CAPSULE, LIQUID FILLED | 48 | 2 | |
| 0363-1756-78 | Nighttime Ultra Concentrated Cold and Flu | 1 in 1 CARTON | CAPSULE, LIQUID FILLED | 1 | 2 |
Products#
Every source-derived product name is available through these pages.
- Nighttime Ultra Concentrated Cold and Flu
- Acetaminophen, Dextromethorphan HBr, Doxylamine succinate softgels
- SORBITAN
- MICA
- POLYETHYLENE GLYCOL, UNSPECIFIED
- POVIDONE
- SHELLAC
- WATER
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- ACETAMINOPHEN
- DOXYLAMINE SUCCINATE
- DOXYLAMINE
- D&C YELLOW NO. 10 ALUMINUM LAKE
- FD&C BLUE NO. 1 ALUMINUM LAKE
- GELATIN
- GLYCERIN
- PROPYLENE GLYCOL
- SORBITOL
- TITANIUM DIOXIDE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0363-1756 | 0363-1756-78 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| SORBITAN | 6O92ICV9RU | IACT |
| MICA | V8A1AW0880 | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| POVIDONE | FZ989GH94E | IACT |
| SHELLAC | 46N107B71O | IACT |
| WATER | 059QF0KO0R | IACT |
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| DOXYLAMINE SUCCINATE | V9BI9B5YI2 | ACTIB |
| D&C YELLOW NO. 10 ALUMINUM LAKE | CQ3XH3DET6 | IACT |
| FD&C BLUE NO. 1 ALUMINUM LAKE | J9EQA3S2JM | IACT |
| GELATIN | 2G86QN327L | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| SORBITOL | 506T60A25R | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
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 |
|---|---|---|---|---|---|---|
| Nighttime Ultra Concentrated Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE SOFTGELS | WALGREENS | 2be0a699-e6ad-ef56-e063-6394a90aaca5 | 2025-04-03 | Warnings | 0363-1756-78 0363-1756 00363175678 31de432c-b86e-4795-e063-6294a90ab4a5 2be0a699-e6ad-ef56-e063-6394a90aaca5 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.

