Indications and uses
temporarily relieves these common cold/flu symptoms: minor aches and pains headache sore throat fever runny nose and sneezing cough due to minor throat and bronchial irritation
Nighttime Cold and Flu
- Manufacturer
- Rite Aid Corporation
- Effective date
- 2025-08-15
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 9
- Source
- full-release
- Hydrated at
- 2026-06-01 01:10:29
Label at a glance#
ProductNighttime Cold and Flu
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE
Label structure10 sections
Dosage and administration
do not take more than directed (see Overdose warning) do not take more than 4 doses in any 24-hour period measure only with dosing cup provided. Do not use any other dosing device. mL= milliliter keep dosing cup with product adults and children 12 years and over: 30 mL every 6 hours children under 12 years of age: do not use When using other Day Time or Night Time products, carefully read each label to ensure corr...
Storage and handling
each 30 mL contains: potassium 5 mg each 30 mL contains: sodium 24 mg store between 20-25ºC (68-77ºF). Do not refrigerate.
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
Purposes
Pain reliever/fever reducer
Cough suppressant
Antihistamine
Uses
temporarily relieves these common cold/flu symptoms:
- minor aches and pains
- headache
- sore throat
- fever
- runny nose and sneezing
- cough due to minor throat and bronchial irritation
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
- 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.
- with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist
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 such smoking, asthma, chronic bronchitis, or emphysema
- trouble urinating due to enlarged prostate gland
Ask a doctor or pharmacist before use if you are taking
- sedatives or tranquilizers
- the blood thinning drug warfarin
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 and tranquilizers may increase drowsiness
Stop use and ask a doctor if
- pain or cough gets worse or lasts more than 7 days
- new symptoms occur
- fever gets worse or lasts more than 7 days
- redness or swelling is present
- 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.
Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. 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 as well as for children even if you do not notice any signs or symptoms.
Directions
- do not take more than directed (see Overdose warning)
- do not take more than 4 doses in any 24-hour period
- measure only with dosing cup provided. Do not use any other dosing device.
- mL= milliliter
- keep dosing cup with product
- adults and children 12 years and over: 30 mL every 6 hours
- children under 12 years of age: do not use
- When using other Day Time or Night Time products, carefully read each label to ensure correct dosing
Other information
- each 30 mL contains: potassium 5 mg
- each 30 mL contains: sodium 24 mg
- store between 20-25ºC (68-77ºF). Do not refrigerate.
Inactive ingredients
acesulfame potassium, alcohol, citric acid, FD&C blue 1, FD&C red 40, flavor,high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate
Questions or comments?
call 1-877-753-3935 Monday-Friday 9AM-5PM EST
Principal Display Panel
Compare to the active ingredients in Vicks® Nyquil® Cold & Flu*
NIGHTTIME
COLD & FLU RELIEF
ACETAMINOPHEN 650 MG
DEXTROMETHORPHAN HBr 30 mg
DOXYLAMINE SUCCINATE 12.5 mg
PAIN RELIEVER / FEVER REDUCER
COUGH SUPPRESSANT
ANTIHISTAMINE
Relieves headache, fever, sore throat, minor aches & pain
Sneezing • Runny nose • Cough
10% Alcohol
For ages 12 years & over
FL OZ (mL)
CHERRY FLAVOR
*This product is not manufactured or distributed by The Procter & Gamble Company.Vicks® and NyQuil® are registered trademarks of The Procter & Gamble Company.
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND DOSAGE CUP OR UNDER CAP IS BROKEN OR MISSING.
DISTRIBUTED BY:
RITE AID, 30 HUNTER LANE
CAMP HILL PA 17011
Product Label
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1043400 | acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 30 mL Oral Solution | PSN | 9 |
| 1043400 | acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution | SCD | 9 |
| 1043400 | acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral Solution | SY | 9 |
| 1043400 | acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral Solution | SY | 9 |
| 1043400 | APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution | SY | 9 |
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#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 11822-3318-0 | 2023-02-22 | C162847 | 48780-1 | f386c64a-33cb-0266-e053-dadaa90a7c1a | Drug Facts |
| 11822-3318-1 | 2023-02-22 | C162847 | 48780-1 | f386c64a-33cb-0266-e053-dadaa90a7c1a | Drug Facts |
| 11822-3318-5 | 2023-02-22 | C162847 | 48780-1 | f386c64a-33cb-0266-e053-dadaa90a7c1a | Drug Facts |
| 11822-3318-0 | 2023-01-30 | C162847 | 48780-1 | f386c64a-33cb-0266-e053-dadaa90a7c1a | Drug Facts |
| 11822-3318-1 | 2023-01-30 | C162847 | 48780-1 | f386c64a-33cb-0266-e053-dadaa90a7c1a | Drug Facts |
| 11822-3318-5 | 2023-01-30 | C162847 | 48780-1 | f386c64a-33cb-0266-e053-dadaa90a7c1a | Drug Facts |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 11822-3318-0 | Nighttime Cold and Flu | 355 mL in 1 BOTTLE, PLASTIC | LIQUID | 355 | 9 | |
| 11822-3318-1 | Nighttime Cold and Flu | 355 mL in 1 BOTTLE, PLASTIC | LIQUID | 355 | 9 | |
| 11822-3318-5 | Nighttime Cold and Flu | 237 mL in 1 BOTTLE, PLASTIC | LIQUID | 237 | 9 |
Products#
Every source-derived product name is available through these pages.
- Nighttime Cold and Flu
- Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate
- ACETAMINOPHEN
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- DOXYLAMINE SUCCINATE
- DOXYLAMINE
- PROPYLENE GLYCOL
- WATER
- ALCOHOL
- ANHYDROUS CITRIC ACID
- HIGH FRUCTOSE CORN SYRUP
- POLYETHYLENE GLYCOL, UNSPECIFIED
- SACCHARIN SODIUM
- TRISODIUM CITRATE DIHYDRATE
- FD&C BLUE NO. 1
- FD&C RED NO. 40
- ACESULFAME POTASSIUM
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 11822-3318 | 11822-3318-1, 11822-3318-0, 11822-3318-5 |
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 |
|---|---|---|---|---|---|---|
| Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Rite Aid Corporation | 25bf4390-23f7-4bb6-b86e-c40eaf8d92da | 2025-08-15 | Warnings | 11822-3318-0 11822-3318-5 11822-3318-1 11822-3318 11822331805 11822331801 11822331800 880d003e-696b-492d-9452-121baba8557b 25bf4390-23f7-4bb6-b86e-c40eaf8d92da |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.