FDA.reportPublic FDA data

LIDL Daytime Cold and Flu Relief

Manufacturer
LIDL US LLC
Effective date
2021-01-19
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:37:06

Label at a glance#

ProductLIDL Daytime Cold and Flu Relief Multi Symptom
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
Label structure8 sections

Indications and 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

Dosage and administration

▪ 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

Label contents#

Full prescribing information#

Active ingredients (in each softgel)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

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.

Allergy alert: Acetaminophen may cause severe skin reaction.

Symptoms may include:

  • skin reddening
  • blisters
  • rash

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

OTC - DO NOT USE SECTION

  • 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

OTC - ASK DOCTOR SECTION

  • 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

OTC - ASK DOCTOR/PHARMACIST SECTION

taking the blood thinning drug warfarin

When using this product

OTC - WHEN USING SECTION

do not use more than directed .

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

  • 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

OTHER SAFETY INFORMATION

  • store at room temperature

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

1-844-656-5151

Principal display panel

PACKAGE LABEL.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

www.lidl.com

LIDL Non- Drowsy Multy Symptoms Daytime cold and Flu Relief 24 softgelsLIDL Non- Drowsy Multy Symptoms Daytime cold and Flu Relief 24 softgels

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1086997acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral CapsulePSN2
1086997acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCD2
1086997APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71141-141-322023-01-30C16284748780-1f386c649-ea7c-0266-e053-dadaa90a7c1aLIDL NON-DROWSY MULTI-SYMPTOM DAYTIME COLD AND FLU RELIEF

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71141-141-32LIDL Daytime Cold and Flu ReliefMulti Symptom24 in 1 BLISTER PACKCAPSULE, LIQUID FILLED242
71141-141-32LIDL Daytime Cold and Flu ReliefMulti Symptom1 in 1 BOXCAPSULE, LIQUID FILLED12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71141-141LIDL DAYTIME COLD AND FLU RELIEF MULTI SYMPTOM (ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [LIDL US LLC]2Legacy NDC, 2 package rows20210120_bd759f58-5912-40d5-a5de-632df3e61a79.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71141-14171141-141-32

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACETAMINOPHEN362O9ITL9DACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
FD&C RED NO. 40WZB9127XOAIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
GELATIN, UNSPECIFIED2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
METHYLPARABENA2I8C7HI9TIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
SORBITAN6O92ICV9RUIACT
TITANIUM DIOXIDE15FIX9V2JPIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ee6d2a51-0a37-4db3-8b5e-aab4a0845b18bd759f58-5912-40d5-a5de-632df3e61a792021-01-19WarningsExact identifier
spl id: ee6d2a51-0a37-4db3-8b5e-aab4a0845b18
spl set id: bd759f58-5912-40d5-a5de-632df3e61a79

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.