Indications and uses
temporarily relieves common cold and flu symptoms: headache minor aches and pains sore throat runny nose and sneezing cough due to minor throat and bronchial irritation temporarily reduces fever
Leader 44-013
- Manufacturer
- Cardinal Health 110, LLC. DBA Leader | LNK International, Inc.
- Effective date
- 2026-08-15
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- daily-update
- Hydrated at
- 2026-08-18 02:02:24
Label at a glance#
ProductCold and Flu Nighttime
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE
Label structure9 sections
Dosage and administration
do not take more than directed do not exceed 4 doses per 24 hours mL = milliliter only use the dose cup provided adults and children 12 years and over: 30 mL every 6 hours children under 12 years: do not use
Storage and handling
each 30 mL contains: sodium 13 mg store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) use by expiration date on package
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredients (in each 30 mL)
Acetaminophen 650 mg
Dextromethorphan HBr 30 mg
Doxylamine succinate 12.5 mg
Purpose
Pain reliever/fever reducer
Cough suppressant
Antihistamine
Uses
- temporarily relieves common cold and flu symptoms:
- headache
- minor aches and pains
- sore throat
- runny nose and sneezing
- cough due to minor throat and bronchial irritation
- temporarily reduces fever
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 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.
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
Ask a doctor before use if you have
- difficulty in urination due to enlargement of the prostate gland
- liver disease
- glaucoma
- a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema
- cough that occurs with too much phlegm (mucus)
Ask a doctor or pharmacist before use if you are
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers
When using this product
- marked drowsiness may occur
- excitability may occur, especially in children
- avoid alcoholic beverages
- alcohol, sedatives, and tranquilizers may increase drowsiness
- use caution when driving a motor vehicle or operating machinery
Stop use and ask a doctor if
- pain or cough gets worse or lasts more than 7 days
- redness or swelling is present
- fever gets worse or lasts more than 3 days
- new symptoms occur
- cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.
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. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
- do not take more than directed
- do not exceed 4 doses per 24 hours
- mL = milliliter
- only use the dose cup provided
- adults and children 12 years and over: 30 mL every 6 hours
- children under 12 years: do not use
Other information
- each 30 mL contains: sodium 13 mg
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- use by expiration date on package
Inactive ingredients
anhydrous citric acid, FD&C blue #1, FD&C red #40, flavor, glycerin, high fructose corn syrup, polyethylene glycol 400, propylene glycol, purified water, sodium benzoate, sodium chloride, sodium citrate dihydrate, sodium saccharin, sucralose
Questions or comments?
1-800-426-9391
Principal display panel
LEADER™
NDC 70000-0673-1
Nighttime
Cold & Flu
Acetaminophen
Dextromethorphan HBr
Doxylamine Succinate
Pain Reliever / Fever Reducer
Cough Suppressant
Antihistamine
Cherry
Flavor
Relief of:
• Headache
• Fever
• Sore Throat
• Minor Aches & Pains
• Sneezing
• Runny Nose
• Cough
For Ages 12 & Over
COMPARE TO
VICKS® NYQUIL®
COLD & FLU
active ingredients*
100% Money
Back Guarantee
12 FL OZ (355 mL)
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0096295143300 | GTIN-13: 0096295143300 EAN-13: 0096295143300 GTIN-12: 096295143300 UPC-A: 096295143300 GTIN storage (14 digits): 00096295143300 | leader-44-013-1.jpg |
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 |
Products#
Every source-derived product name is available through these pages.
- Cold and Flu Nighttime
- Acetaminophen, Dextromethorphan HBr, Doxylamine succinate
- ACETAMINOPHEN
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- DOXYLAMINE SUCCINATE
- DOXYLAMINE
- ANHYDROUS CITRIC ACID
- FD&C BLUE NO. 1
- FD&C RED NO. 40
- GLYCERIN
- HIGH FRUCTOSE CORN SYRUP
- POLYETHYLENE GLYCOL 400
- PROPYLENE GLYCOL
- WATER
- SODIUM BENZOATE
- SODIUM CHLORIDE
- TRISODIUM CITRATE DIHYDRATE
- SACCHARIN SODIUM
- SUCRALOSE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 70000-0673 | 70000-0673-1 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 2 | 2025-08-13 | full-release | 2026-06-01 01:10:39 |
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 |
|---|---|---|---|---|---|---|
| Cold and Flu Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Cardinal Health 110, LLC. DBA Leader | b1c2055b-4b5a-4fa2-b600-8930c9c8524c | 2026-08-15 | Warnings | 70000-0673-1 70000-0673 70000067301 3ea43c67-c34d-4876-8a74-972b84b14b52 b1c2055b-4b5a-4fa2-b600-8930c9c8524c |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.