temporarily relieves common cold/flu symptoms: nasal congestion sore throat headache sinus congestion and pressure minor aches and pain runny nose and sneezing cough due to minor throat and bronchial irritation temporarily reduces fever cough to help you sleep swelling of nasal passage temporarily restores freer breathing through the nose promotes nasal and/or sinus drainage
take only as directed - see Overdose warning do not exceed 4 doses per 24 hours 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 4 hours children under 12 years of age: do not use When using Day Time or Night Time products, carefully read each label to ensure correct dosing.
each 30 mL contains ; sodium 64 mg store between 20-25ºC (68-77ºF). Do not refrigerate
Acetaminophen 650 mg
Dextromethorphan HBr 20 mg
Doxylamine succinate 12.5 mg
Phenylephrine HCI 10 mg
Pain reliever/fever reducer
Cough suppressant
Antihistamine
Nasal Decongestant
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
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.
These could be a signs of a serious conditions.
ask a health professional before use.
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 even if you do not notice any signs or symptoms.
anhydrous citric acid. FD&C blue1, FD&C red 40, Flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sorbitol, sucralose, trisodium citrate dihydrate, xanthan gum
Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
Compare to the active ingredients in Vicks® Nyquil® Severe Cold & Flu*
maximum strength
severe
night time
cold & flu relief
Acetaminophen 650 mg
Pain Reliever/Fever Reducer
dextromethorphan HBr 20 mg
Cough Suppressant
doxylamine succinate 12.5 mg
Antihistamine
phenylephrine HCI 10 mg
nasal decongestant
relieves
alcohol free
berry flavor
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 DOSAGE CUPOR UNDER CAP IS BROKEN OR MISSING.
Manufactured by:
PL Developments
11865 S. Alameda St
Lynwood, CA 90262
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1431245 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG / phenylephrine HCl 10 MG in 30 mL Oral Solution | PSN | 4 |
| 1431245 | acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / doxylamine succinate 0.417 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution | SCD | 4 |
| 1431245 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG per 15 ML Oral Solution | SY | 4 |
| 1431245 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG / phenylephrine HCl 10 MG per 30 ML Oral Solution | SY | 4 |
| 1431245 | APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 0.667 MG/ML / doxylamine succinate 0.417 MG/ML / Phenylephrine Hydrochloride 0.333 MG/ML Oral Solution | SY | 4 |
| Class | Version | Type | Effective |
|---|---|---|---|
| DEXTROMETHORPHAN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| DOXYLAMINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| PHENYLEPHRINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 49580-4160-8 | 2023-05-22 | C162847 | 48780-1 | f386c64a-0a3f-0266-e053-dadaa90a7c1a | Drug Facts |
| 49580-4160-8 | 2023-01-30 | C162847 | 48780-1 | f386c64a-0a3f-0266-e053-dadaa90a7c1a | Drug Facts |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 49580-4160-8 | Severe cold and fluNighttime | 237 mL in 1 BOTTLE, PLASTIC | LIQUID | 237 | 4 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 49580-4160 | SEVERE COLD AND FLU NIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCI) LIQUID [P & L DEVELOPMENT, LLC] | 4 | Current NDC, Legacy NDC, 1 package rows | 20240426_15727e06-7bfc-424e-9e68-cc9cd5695bfd.zip |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 49580-4160 | 49580-4160-8 |
Every source-derived ingredient row is available through these pages.
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 |
|---|---|---|---|---|---|---|
| Severe cold and flu Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCI | P & L Development, LLC | 15727e06-7bfc-424e-9e68-cc9cd5695bfd | 2024-04-25 | Warnings | 49580-4160-8 49580-4160 49580416008 5abd1181-9a9d-4de6-9215-a3c36ae16a43 15727e06-7bfc-424e-9e68-cc9cd5695bfd |
Adverse event summaries are temporarily unavailable. Other product information remains available.