Active Ingredients (In Each 30 Ml)
Acetaminophen 650 mg
Dextromethorphan HBr 30 mg
Doxylamine succinate 12.5 mg
Nighttime Cold And Flu Relief Liquid
FDA Label NDC 83324-164
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Quality Choice (chain Drug Marketing Association) for the product Nighttime Cold And Flu Relief (NDC 83324-164). 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
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 doses of acetaminophen in 24 hours
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day 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 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 that lasts or occurs with smoking, asthma, chronic bronchitis, or emphysema
- trouble urinating due to an 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-hours 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 Daytime or Nighttime products, carefully read each label to ensure correct dosing
Other Information
- each 30 mL contains: potassium 5 mg
- each 30 mL contains: Sodium 19 mg
- store between 20-25°C (68-77°F). 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
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*Compare to the active ingredients in Vicks® NyQuil® Cold & Flu
Nighttime
Cold & Flu Relief
Acetaminophen / 650 mg
Pain reliever/Fever reducer
Dextromethorphan HBr 30 mg
Cough suppressant
Doxylamine succinate 12.5 mg
Antihistamine
- Headache, fever, sore throat, minor aches & pains,
- Sneezing,
- Runny nose
- Cough
For ages 12 years & over
Nighttime relief
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 DOSAGE CUP OR UNDER CAP IS BROKEN OR MISSING.
DISTRIBUTED BY:
Product Label
QUALITY CHOICE Nighttime Cold & Flu Relief
* Please review the disclaimer below.
