Active Ingredients (In Each 30 Ml)
Acetaminophen 650 mg
Dextromethorphan HBr 20 mg
Doxylamine succinate 12.5 mg
Phenylephrine HCI 10 mg
Severe Nighttime Cold And Flu Relief Liquid
FDA Label NDC 55319-641
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Family Dollar (family Wellness) for the product Severe Nighttime Cold And Flu Relief (NDC 55319-641). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients (in each 30 ml), purposes, uses, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are taking, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purposes
Pain reliever/fever reducer
Cough suppressant
Antihistamine
Nasal Decongestant
Uses
- temporarily relieves common cold/flu symptoms:
- nasal congestion
- sore throat
- headache
- sinus congestion and pressure
- minor ache 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 passages
- temporarily restores freer breathing through the nose
- promotes nasal and/or sinus drainage
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 everyday while using this product
- skin reddening
- blisters
- rash
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 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
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- glaucoma
- trouble urinating due to an enlarges prostate gland
- cough that occurs with too much phlegm (mucus)
- a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema
- a sodium-restricted diet
Ask A Doctor Or Pharmacist Before Use If You Are Taking
- taking sedatives or tranquilizers
- taking the blood thinning drug warfarin
When Using This Product
- do not use more than directed
- 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
- nervousness, dizziness, or sleeplessness occur
- pain, nasal congestion, or cough gets worse or lasts more than 7 days
- new symptoms occur
- fever gets worse or last more than 3 days
- redness or swelling is present
- cough comes back, or occurs with rash or headache that lasts.
These could be a signs of a serious conditions.
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 even if you do not notice any signs or symptoms.
Directions
- 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 Daytime or Nighttime products, carefully read each label to ensure correct dosing.
Other Information
- each 30 mL contains; sodium 64 mg
- store between 20-25°C (68-77°F). Do not refrigerate
Inactive Ingredients
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
Questions Or Comments?
Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
Principal Display Panel
COMPARE TO THE ACTIVE INGREDIENTS IN VICKS® NYQUIL™ SEVERE COLD & FLU*
NIGHTTIME
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
- Headache, fever, sore throat, minor aches & pains
- Nasal/sinus congestion & sinus pressure
- Sneezing
- Runny nose
- Cough
Alcohol free
FL OZ (mL)
BERRY 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: MIDWOOD BRANDS, LLC
510 VOLVO PKWY, CHESAPEAKE, VA 23320
Product Label
FAMILY WELLNESS Nighttime Cold & Flu Relief
* Please review the disclaimer below.
