Active Ingredients (In Each Softgel)
Acetaminophen 325 mg
Dextromethorphan HBr 15 mg
Doxylamine succinate 6.25 mg
Lidl Nightyime Cold And Flu Relief
FDA Label NDC 71141-142
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Lidl Us Llc for the product Lidl Nightyime Cold And Flu Relief (NDC 71141-142). 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 softgel), 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
▪ 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 daily 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 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 product 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 of pharmacist before taking this product.▪ to make a child sleep
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 lasts or as 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▪ 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▪ marked drowsiness may occur▪ avoid alcoholic drinks▪ be careful when driving a motor vehicle or operating machinery▪ alcohol, sedatives & tranquilizers may increase drowsiness
Stop Use And Ask A Doctor If
▪ pain or cough gets worse or lasts more than 7 days▪ fever gets worse or lasts more than 3 days▪ redness or swelling is present▪ new symptoms occur▪ 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 directed can cause serious health problems. 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 & children, even if you do not notice any signs or symptoms.
Directions
▪ take only as directed- see Overdose warning▪ do not exceed 4 doses in 24 hours
adults and children 12 years and over | 2 softgels with water every 6 hours |
children 4 to under 12 years | ask a doctor |
children under 4 years | do not use |
Other Information
- store at room temperature
Inactive Ingredients
D&C yellow No. 10, FD&C Blue No. 1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol, sorbitan, titanium dioxide.
Questions Or Comments?
1-844-656-5151
Principal Display Panel
*Compare to the active ingredients in Vicks® NyQuil® Cold & Flu liquicaps®
NDC 71141-142-32
RELIEVES
Headache
Fever & Sore throat
Minor aches & pains
Sneezing
Runny Nose
Cough
Nighttime Cold & Flue RELIEF
Acetaminophen 325 mg Pain reliever/Fever reducer
Dextromethorphan HBr 15 mg Cough suppressant
Doxylamine succinate 6.25 mg Antihistamine
24 Softgels
For ages 12 years and overs
*This product is not manufactured or distributed by Procter & Gamble, distributor of Vicks® Nyquil® Cold & Flu LiquiCaps®
DISTRIBUTED BY
Lidl US, LLC
3500 S. Clark Street
Arlington, VA 22202
QUESTIONS?
1-844-656-5151
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
TAMPER EVIDENT: This package is safety sealed & child resistant. Use only if blisters are intact. If difficult to open, use scissors.
* Please review the disclaimer below.
