Active Ingredients (In Each Softgel)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg
Lidl Daytime Cold And Flu Relief
FDA Label NDC 71141-141
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 Daytime Cold And Flu Relief (NDC 71141-141). 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
Nasal decongestant
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 & 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 reaction.
Symptoms may include:
If a skin reaction occurs, stop use and seek medical help right away.
Sore throat warning: If sore throat is severe, lasts 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.
Ask A Doctor Before Use If You Have
- liver disease
- heart disease
- thyroid disease
- diabetes
- high blood pressure
- cough that occurs with too much phlegm (mucus)
- a breathing problem or chronic cough that lasts or as occurs
- trouble urinating due to enlarged prostate gland
Ask A Doctor Or Pharmacist Before Use If You Are
taking the blood thinning drug warfarin
When Using This Product
do not use more than directed .
Stop Use And Ask A Doctor If
▪ you get nervous, dizzy or sleepless▪ symptoms get worse or last more than 5 days (children) or 7 days (adults)▪ 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 the directed can cause serious health problem. 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 & children, 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
adults and children 12 years and over | 2 softgels with water every 4 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
FD&C red no. 40, FD&C yellow no. 6, gelatin, glycerin, methyl paraben, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan and titanium dioxide.
Questions Or Comments?
1-844-656-5151
Principal Display Panel
*Compare to the active ingredients in Vicks® Dayquil® Cold & Flu Liquicaps®
NDC 71141-141-32
RELIEVES
Aches, Fever, Sore Throat
Cough & Nasal Congestion
Non-Drowsy Multi-Symptom
Daytime cold & flu RELIEF
24 Softgels
Alcohol-free
Antihistamine-free
Acetaminophen 325 mg Pain reliever/Fever reducer
Dextromethorphan HBr 10 mg Cough suppressant
Phenylephrine HCL 5 mg Nasal decongestant
*This product is not manufactured or distributed by Procter & Gamble, distributor of Vicks® Dayquil® Cold & Flu LiquiCaps®
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.
DISTRIBUTED BY
Lidl US, LLC
3500 S. Clark Street
Arlington, VA 22202
QUESTIONS?
1-844-656-5151
* Please review the disclaimer below.
