Nightime
- Manufacturer
- H-E-B | TIME CAP LABORATORIES INC. | MARKSANS PHARMA LIMITED
- Effective date
- 2023-01-13
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- full-release
- Hydrated at
- 2026-06-01 00:55:25
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Active ingredients (in each softgel)
Acetaminophen 325 mg
Dextromethorphan HBr 15 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 4 doses in 24 hrs, which is the maximum daily amount for this product
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks daily 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, lasts 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
- 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, & 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 (1-800-222-1222) right away.
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 12 yrs & over: 2 softgels with water every 6 hrs
children 4 to under 12 yrs: ask a doctor
children under 4 yrs: do not use
OTHER SAFETY INFORMATION
Other information
- store at room temperature
INACTIVE INGREDIENT SECTION
Inactive ingredients FD&C blue #1, D&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 |
|---|---|---|---|
| 1094549 | acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule | PSN | 3 |
| 1094549 | acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule | SCD | 3 |
| 1094549 | APAP 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 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 |
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 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 37808-095-16 | 2025-02-14 | C162847 | 48780-1 | 2cef2736-888e-d83d-e063-dadaa90ab31f | 694T HEB 37808-095 Nighttime Cold & Flu Softgels 16s |
| 37808-095-16 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-888e-d83d-e063-dadaa90ab31f | 694T HEB 37808-095 Nighttime Cold & Flu Softgels 16s |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 37808-095-16 | Nightime | 1 in 1 CARTON | CAPSULE, LIQUID FILLED | 1 | 3 | |
| 37808-095-16 | Nightime | 8 in 1 BLISTER PACK | CAPSULE, LIQUID FILLED | 8 | 3 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Nightime
- Acetaminophen Dextromethorphan HBr Doxylamine Succinate
- FD&C BLUE NO. 1
- GELATIN
- POVIDONE
- WATER
- POLYETHYLENE GLYCOL, UNSPECIFIED
- TITANIUM DIOXIDE
- SHELLAC
- PROPYLENE GLYCOL
- SORBITAN
- D&C YELLOW NO. 10
- GLYCERIN
- ACETAMINOPHEN
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- DOXYLAMINE SUCCINATE
- DOXYLAMINE
- SORBITOL SOLUTION
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 37808-095 | 37808-095-16 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| GELATIN | 2G86QN327L | IACT |
| POVIDONE | FZ989GH94E | IACT |
| WATER | 059QF0KO0R | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| SHELLAC | 46N107B71O | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| SORBITAN | 6O92ICV9RU | IACT |
| D&C YELLOW NO. 10 | 35SW5USQ3G | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| DOXYLAMINE SUCCINATE | V9BI9B5YI2 | ACTIB |
| SORBITOL SOLUTION | 8KW3E207O2 | 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 |
|---|---|---|---|---|---|---|
| Nightime | ACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATE | H-E-B | db44560b-da02-74c9-e053-2a95a90af0b6 | 2023-01-13 | Warnings | 37808-095-16 37808-095 37808009516 f2332918-58b0-8f7c-e053-2a95a90ac056 db44560b-da02-74c9-e053-2a95a90af0b6 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
