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
- P & L Development, LLC
- Effective date
- 2024-02-02
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 9
- Source
- full-release
- Hydrated at
- 2026-06-01 00:08:15
Label at a glance#
ProductNighttime Cold and Flu ReadyInCase
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 peroid 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 insure cor...
Storage and handling
each 30 mL contains; potassium 5 mg each 30 mL contain sodium 19 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 is 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 such as occurs with 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 3 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 peroid
- 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 insure correct dosing
Other information
- each 30 mL contains; potassium 5 mg
- each 30 mL contain sodium 19 mg
- store between 20-25ºC (68-77ºF). Do not refrigerate
Inactive ingredients
acesulfame potassium, alcohol, citric acid, D&C yellow 10, FD&C green 3, FD&C yellow 6, 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 active ingredients in Vicks® NyQuil®* Cold & Flu*
Night Time
Cold & Flu relief
Acetaminophen 650 mg
Dextromethorphan HBr 30 mg
Doxylamine succinate 12.5 mg
pain reliever/fever reducer
cough suppressant
antihistamine
relieves:
- fever,
- headache
- sore throat
- cough
- minor aches and pains
- runny nose & sneezing
for ages 12 years & over
alcohol 10%
FL OZ (mL)
*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 BOTTLE OR UNDER CAP IS BROKEN OR MISSING.
Manufactured by:
PL Developments
11865 S. Alameda St
Lynwood, CA 90262
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#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 49580-0346-2 | Nighttime Cold and FluReadyInCase | 355 mL in 1 BOTTLE, PLASTIC | LIQUID | 355 | 9 | |
| 49580-0346-4 | Nighttime Cold and FluReadyInCase | 118 mL in 1 BOTTLE, PLASTIC | LIQUID | 118 | 9 | |
| 49580-0346-8 | Nighttime Cold and FluReadyInCase | 237 mL in 1 BOTTLE, PLASTIC | LIQUID | 237 | 9 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 49580-0346 | NIGHTTIME COLD AND FLU READYINCASE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [P & L DEVELOPMENT, LLC] | 9 | Current NDC, Legacy NDC, 3 package rows | 20240203_155a7168-b568-41f4-b8a2-214889b4eccf.zip |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| ACETAMINOPHEN | ACTIVE INGREDIENT | 362O9ITL9D | 3 | |
| DEXTROMETHORPHAN HYDROBROMIDE | ACTIVE INGREDIENT | 9D2RTI9KYH | 3 | |
| DOXYLAMINE SUCCINATE | ACTIVE INGREDIENT | V9BI9B5YI2 | 3 | |
| ACETAMINOPHEN | ACTIVE MOIETY | 362O9ITL9D | 3 | |
| DEXTROMETHORPHAN | ACTIVE MOIETY | 7355X3ROTS | 3 | |
| DOXYLAMINE | ACTIVE MOIETY | 95QB77JKPL | 3 | |
| ACESULFAME POTASSIUM | INACTIVE INGREDIENT | 23OV73Q5G9 | 3 | |
| ALCOHOL | INACTIVE INGREDIENT | 3K9958V90M | 3 | |
| ANHYDROUS CITRIC ACID | INACTIVE INGREDIENT | XF417D3PSL | 3 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | 3 | |
| FD&C GREEN NO. 3 | INACTIVE INGREDIENT | 3P3ONR6O1S | 3 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | 3 | |
| HIGH FRUCTOSE CORN SYRUP | INACTIVE INGREDIENT | XY6UN3QB6S | 3 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | 3 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | 3 | |
| SACCHARIN SODIUM | INACTIVE INGREDIENT | SB8ZUX40TY | 3 | |
| TRISODIUM CITRATE DIHYDRATE | INACTIVE INGREDIENT | B22547B95K | 3 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 3 |
Products#
Every source-derived product name is available through these pages.
- Nighttime Cold and Flu ReadyInCase
- Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate
- ACETAMINOPHEN
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- DOXYLAMINE SUCCINATE
- DOXYLAMINE
- PROPYLENE GLYCOL
- WATER
- ACESULFAME POTASSIUM
- ALCOHOL
- ANHYDROUS CITRIC ACID
- HIGH FRUCTOSE CORN SYRUP
- POLYETHYLENE GLYCOL, UNSPECIFIED
- SACCHARIN SODIUM
- TRISODIUM CITRATE DIHYDRATE
- D&C YELLOW NO. 10
- FD&C GREEN NO. 3
- FD&C YELLOW NO. 6
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 49580-0346 | 49580-0346-8, 49580-0346-2, 49580-0346-4 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | SUSPENSION, EXTENDED RELEASE / ORAL | 62 mg | ||
| FD&C GREEN NO. 3 | FD&C GREEN NO. 3 | 3P3ONR6O1S | ELIXIR / ORAL | NA | ||
| D&C YELLOW NO. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | CAPSULE, DELAYED RELEASE / ORAL | 1 mg | ||
| FD&C GREEN NO. 3 | FD&C GREEN NO. 3 | 3P3ONR6O1S | CAPSULE / ORAL | 40 mg | ||
| ACESULFAME POTASSIUM | ACESULFAME POTASSIUM | 23OV73Q5G9 | TABLET, CHEWABLE / ORAL | 15 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | SYRUP / ORAL | 268 mg | ||
| D&C YELLOW NO. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | CAPSULE, COATED PELLETS / ORAL | 0.01 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | POWDER, FOR SOLUTION / ORAL | 123 mg | ||
| ACESULFAME POTASSIUM | ACESULFAME POTASSIUM | 23OV73Q5G9 | LOZENGE / ORAL | 120 mg | ||
| ACESULFAME POTASSIUM | ACESULFAME POTASSIUM | 23OV73Q5G9 | SUSPENSION / ORAL | 160 mg | ||
| D&C YELLOW NO. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | TABLET / ORAL | 80 mg | ||
| D&C YELLOW NO. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | CAPSULE, COATED PELLETS / ORAL | 0.01 mg | ||
| TRISODIUM CITRATE DIHYDRATE | TRISODIUM CITRATE DIHYDRATE | B22547B95K | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 200 mg | ||
| D&C YELLOW NO. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | CAPSULE / ORAL | 20 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | POWDER, FOR SUSPENSION / ORAL | 570 mg | ||
| FD&C GREEN NO. 3 | FD&C GREEN NO. 3 | 3P3ONR6O1S | SYRUP / ORAL | 3.75 mg/5ml | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | TABLET, CHEWABLE / ORAL | 4 mg | ||
| TRISODIUM CITRATE DIHYDRATE | TRISODIUM CITRATE DIHYDRATE | B22547B95K | GRANULE, FOR SUSPENSION / ORAL | 4950 mg | ||
| ACESULFAME POTASSIUM | ACESULFAME POTASSIUM | 23OV73Q5G9 | TROCHE / ORAL | 26 mg | ||
| TRISODIUM CITRATE DIHYDRATE | TRISODIUM CITRATE DIHYDRATE | B22547B95K | POWDER, FOR SUSPENSION / ORAL | 5010 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | SUSPENSION / ORAL | 400 mg | ||
| D&C YELLOW NO. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | CAPSULE / ORAL | 20 mg | ||
| FD&C GREEN NO. 3 | FD&C GREEN NO. 3 | 3P3ONR6O1S | CAPSULE, DELAYED RELEASE / ORAL | 5 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | FILM, SOLUBLE / ORAL | 7 mg | ||
| D&C YELLOW NO. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | CAPSULE, LIQUID FILLED / ORAL | 1.51 mg | ||
| D&C YELLOW NO. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | CONCENTRATE / ORAL | 0.03 mg/1ml | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | CAPSULE / ORAL | 131 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | POWDER, FOR SUSPENSION / ORAL | 570 mg | ||
| TRISODIUM CITRATE DIHYDRATE | TRISODIUM CITRATE DIHYDRATE | B22547B95K | SUSPENSION, EXTENDED RELEASE / ORAL | 9 mg | ||
| TRISODIUM CITRATE DIHYDRATE | TRISODIUM CITRATE DIHYDRATE | B22547B95K | TABLET, CHEWABLE / ORAL | 14 mg | ||
| FD&C GREEN NO. 3 | FD&C GREEN NO. 3 | 3P3ONR6O1S | SYRUP / ORAL | 3.75 mg/5ml | ||
| D&C YELLOW NO. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | TABLET, FILM COATED / ORAL | 120 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | SUSPENSION / ORAL | 400 mg | ||
| TRISODIUM CITRATE DIHYDRATE | TRISODIUM CITRATE DIHYDRATE | B22547B95K | GRANULE, FOR SUSPENSION / ORAL | 4950 mg | ||
| TRISODIUM CITRATE DIHYDRATE | TRISODIUM CITRATE DIHYDRATE | B22547B95K | CAPSULE / ORAL | 35 mg | ||
| D&C YELLOW NO. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | POWDER, FOR SOLUTION / ORAL | NA | ||
| TRISODIUM CITRATE DIHYDRATE | TRISODIUM CITRATE DIHYDRATE | B22547B95K | TABLET, DELAYED RELEASE / ORAL | 640 mg | ||
| TRISODIUM CITRATE DIHYDRATE | TRISODIUM CITRATE DIHYDRATE | B22547B95K | SYRUP / ORAL | 705 mg | ||
| D&C YELLOW NO. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | CONCENTRATE / ORAL | 0.03 mg/1ml | ||
| FD&C GREEN NO. 3 | FD&C GREEN NO. 3 | 3P3ONR6O1S | SOLUTION / ORAL | 0.25 mg/5ml | ||
| D&C YELLOW NO. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | SYRUP / ORAL | 4 mg | ||
| TRISODIUM CITRATE DIHYDRATE | TRISODIUM CITRATE DIHYDRATE | B22547B95K | TABLET / ORAL | 896 mg | ||
| HIGH FRUCTOSE CORN SYRUP | HIGH FRUCTOSE CORN SYRUP | XY6UN3QB6S | SUSPENSION / ORAL | 20000 mg | ||
| D&C YELLOW NO. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | SUSPENSION / ORAL | 20 mg/5ml | ||
| D&C YELLOW NO. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | TABLET, CHEWABLE / ORAL | 4 mg | ||
| HIGH FRUCTOSE CORN SYRUP | HIGH FRUCTOSE CORN SYRUP | XY6UN3QB6S | SOLUTION / ORAL | 10000 mg | ||
| D&C YELLOW NO. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | TABLET, COATED / ORAL | 2.5 mg | ||
| ACESULFAME POTASSIUM | ACESULFAME POTASSIUM | 23OV73Q5G9 | SUSPENSION / ORAL | 160 mg | ||
| ACESULFAME POTASSIUM | ACESULFAME POTASSIUM | 23OV73Q5G9 | TABLET, CHEWABLE / ORAL | 15 mg | ||
| ACESULFAME POTASSIUM | ACESULFAME POTASSIUM | 23OV73Q5G9 | POWDER, FOR SUSPENSION / ORAL | 45 mg/5ml | ||
| FD&C GREEN NO. 3 | FD&C GREEN NO. 3 | 3P3ONR6O1S | TABLET, DELAYED RELEASE / ORAL | NA | ||
| TRISODIUM CITRATE DIHYDRATE | TRISODIUM CITRATE DIHYDRATE | B22547B95K | TABLET, DELAYED RELEASE / ORAL | 640 mg | ||
| FD&C GREEN NO. 3 | FD&C GREEN NO. 3 | 3P3ONR6O1S | ELIXIR / ORAL | NA | ||
| D&C YELLOW NO. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | CAPSULE, COATED PELLETS / ORAL | 0.01 mg | ||
| HIGH FRUCTOSE CORN SYRUP | HIGH FRUCTOSE CORN SYRUP | XY6UN3QB6S | SUSPENSION / ORAL | 20000 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | POWDER, FOR SUSPENSION / ORAL | 570 mg | ||
| D&C YELLOW NO. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | POWDER, FOR SUSPENSION / ORAL | 76 mg | ||
| FD&C GREEN NO. 3 | FD&C GREEN NO. 3 | 3P3ONR6O1S | SYRUP / ORAL | 3.75 mg/5ml | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | SUSPENSION, EXTENDED RELEASE / ORAL | 62 mg | ||
| ACESULFAME POTASSIUM | ACESULFAME POTASSIUM | 23OV73Q5G9 | POWDER, FOR SUSPENSION / ORAL | 45 mg/5ml |
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 ReadyInCase | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | P & L Development, LLC | 155a7168-b568-41f4-b8a2-214889b4eccf | 2024-02-02 | Warnings | 49580-0346-2 49580-0346-8 49580-0346-4 49580-0346 49580034602 49580034604 49580034608 822c9254-9dc0-40fd-9057-2fc60e0bd248 155a7168-b568-41f4-b8a2-214889b4eccf |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.