Label: LIDL DAYTIME COLD AND FLU RELIEF MULTI SYMPTOM- acetaminohpen, dextromethorphan hbr, phenylephrine hcl capsule, liquid filled

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated January 19, 2021

If you are a consumer or patient please visit this version.

  • Active ingredients (in each softgel)

    Acetaminophen 325 mg

    Dextromethorphan HBr 10 mg

    Phenylephrine HCl 5 mg

    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.

    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

    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

    www.lidl.com

    LIDL Non- Drowsy Multy Symptoms Daytime cold and Flu Relief 24 softgels
  • INGREDIENTS AND APPEARANCE
    LIDL DAYTIME COLD AND FLU RELIEF  MULTI SYMPTOM
    acetaminohpen, dextromethorphan hbr, phenylephrine hcl capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71141-141
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    SORBITAN (UNII: 6O92ICV9RU)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorORANGE (orange) Scoreno score
    ShapeCAPSULE (oblong) Size10mm
    FlavorImprint Code RP061
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71141-141-321 in 1 BOX04/18/2019
    124 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34104/18/2019
    Labeler - LIDL US LLC (079389709)