temporarily relieves common cold/flu symptoms: • nasal congestion • sinus congestion & pressure • cough due to minor throat & bronchial irritation • cough to help you sleep • minor aches & pains • headache • fever • sore throat • runny nose & sneezing • reduces swelling of nasal passages • temporarily restores freer breathing through the nose • promotes nasal and/or sinus drainage
• take only as directed • only use the dose cup provided • do not exceed 4 doses per 24 hrs adults & children 12 yrs & over 30 mL every 4 hrs children 4 to under 12 yrs ask a doctor children under 4 years do not use
• each 30 mL contains: sodium 77 mg • Store at room temperature. • Do not refrigerate.
Drug Facts
Active ingredients (in each 30 mL)
Acetaminophen 650 mg
Dextromethorphan HBr 20 mg
Doxylamine succinate 12.5 mg
Phenylephrine HCl 10 mg
Pain reliever/fever reducer
Cough suppressant
Antihistamine
Nasal decongestant
temporarily relieves common cold/flu symptoms:
This product contains acetaminophen. Severe liver damage may occur if you take
Acetaminophen may cause severe skin reactions. Symptoms may include:
If a skin reaction occurs, stop use and seek medical help right away
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 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 at 1-800-222-1222 . Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
adults & children 12 yrs & over | 30 mL every 4 hrs |
children 4 to under 12 yrs | ask a doctor |
children under 4 years | do not use |
Anhydrous citric acid, disodium edetate, FD&C Red No. 40, FD&C Blue No. 1, flavors, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sodium chloride, sodium citrate dihydrate, sorbitol, sucralose, xanthan gum.
1-866-467-2748
Distributed by:
*Compare to the active ingredients inVICKS® NyQuil™ Severe Cold & Flu
NDC 55319-681-08
Severe
NightTime
Cold & Flu
Relief
Acetaminophen- Pain reliever/Fever reducer
Phenylephrine HCl – Nasal decongestant
Doxylamine Succinate - Antihistamine
Dextromethorphan HBr – Cough suppressant
Minor Aches & Pains
Mixed Berry Flavor
Naturally and Artificially Flavored
8 FL OZ (236 ml)
| 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 | 1 |
| 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 | 1 |
| 1431245 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG per 15 ML Oral Solution | SY | 1 |
| 1431245 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG / phenylephrine HCl 10 MG per 30 ML Oral Solution | SY | 1 |
| 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 | 1 |
| 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 |
|---|---|---|---|---|---|
| 55319-681-08 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-a823-d83d-e063-dadaa90ab31f | Severe NightTime Cold & Flu Relief |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55319-681-08 | Family DollarSevere Nighttime Cold and Flu | 236 mL in 1 BOTTLE, PLASTIC | SOLUTION | 236 | 1 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 55319-681 | FAMILY DOLLARSEVERE NIGHTTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [FAMILY DOLLAR SERVICES INC] | 1 | 1 package rows | 20230727_484fb43b-8a97-4725-9ea7-aa56fb3610bc.zip |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 55319-681 | 55319-681-08 |
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 |
|---|---|---|---|---|---|---|
| 484fb43b-8a97-4725-9ea7-aa56fb3610bc | 484fb43b-8a97-4725-9ea7-aa56fb3610bc | 2023-07-26 | Warnings | 484fb43b-8a97-4725-9ea7-aa56fb3610bc 484fb43b-8a97-4725-9ea7-aa56fb3610bc |
Adverse event summaries are temporarily unavailable. Other product information remains available.