Active Ingredients (In Each 30 Ml)
Acetaminophen 650 mg
Dextromethorphan HBr 30 mg
Doxylamine succinate 12.5 mg
Cvs Nighttime Cold And Flu Relief Solution
FDA Label NDC 51316-692
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cvs Pharmacy for the product Cvs Nighttime Cold And Flu Relief (NDC 51316-692). 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), purpose, uses, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Pain reliever/fever reducer
Cough suppressant
Antihistamine
Uses
temporarily relieves common cold/flu symptoms:
▪ cough due to minor throat and bronchial irritation▪ sore throat▪ headache▪ minor aches and pains▪ fever▪ runny nose and sneezing
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- more than 4 doses in 24 hours, which is the maximum daily amount for this product
- 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
▪ with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.▪ 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.▪ if you have ever had an allergic reaction to this product or any of its ingredients
Ask A Doctor Before Use If You Have
▪ liver disease▪ glaucoma▪ cough that occurs with too much phlegm (mucus)▪ a breathing problem such as emphysema or chronic bronchitis▪ trouble urinating due to an enlarged prostate gland▪ persistent or chronic cough as occurs with smoking, asthma, or emphysema▪ a sodium-restricted diet
Ask A Doctor Or Pharmacist Before Use If You Are
▪ taking sedatives or tranquilizers▪ taking 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
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Keep Out Of Reach Of Children.
Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (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.
Directions
- 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 6 hrs |
children 4 to under 12 yrs | ask a doctor |
children under 4 yrs | do not use |
Other Information
- each 30 mL contains: sodium 16 mg
- store at room temperature and do not refrigerate
Inactive Ingredients
anhydrous citric acid, D&C Yellow No. 10, disodium edetate, FD&C Green No. 3, FD & C Yellow No 6, flavors, propylene glycol, propyl gallate, purified water, sodium benzoate, sodium citrate, sorbitol liquid, sucralose.
Questions Or Comments?
1-866-467-2748
Package/Label Principal Display Panel
Compare to the active ingredients in VICKS® Nyquil™Cold & Flu*
NDC 51316-692-12
Nighttime Cold & Flue Relief
Acetaminophen, Dextromethorphan succinate,
Doxylamine HBr
Headache, Fever, Sore Throat
Minor Aches & Pains
Sneezing, Runny Nose, Cough
Original Flavor
12 FL OZ (354 mL)
Distributed by:
*This product is not manufactured or distributed by Procter & Gamble, the distributor of Vicks® Nyquil™Cold & Flu*
* Please review the disclaimer below.
