Label: COLD AND FLU- acetaminophen, dextromethorphan hbr, phenylephrine hcl solution

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 20, 2024

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  • Active ingredients (in each 15 mL)

    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 and flu symptoms:
      • sore throat
      • nasal congestion
      • headache
      • minor aches and pains
      • cough due to minor throat and bronchial irritation
    • temporarily reduces fever
  • Warnings

    Liver warning: This product contains acetaminophen. Severe liver damage may occur if

    • adult takes more than 4,000 mg of acetaminophen in 24 hours
    • child takes more than 5 doses in 24 hours
    • taken with other drugs containing acetaminophen
    • adult has 3 or more alcoholic drinks every day while using this product

    Allergy alert: Acetaminophen may cause severe skin reactions. 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, 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 the user has

    • difficulty in urination due to enlargement of the prostate gland
    • cough that occurs with too much phlegm (mucus)
    • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
    • heart disease
    • diabetes
    • thyroid disease
    • liver disease
    • high blood pressure

    Ask a doctor or pharmacist before use if the user is

    taking the blood thinning drug warfarin.

    When using this product

    do not exceed recommended dosage.

    Stop use and ask a doctor if

    • nervousness, dizziness, or sleeplessness occur
    • fever gets worse or lasts more than 3 days
    • redness or swelling is present
    • new symptoms occur
    • pain, nasal congestion, or cough gets worse or lasts more than 5 days (children) or 7 days (adults)
    • 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.

    In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • Directions

    • do not take more than directed
    • do not exceed 4 doses per 24 hours
    • mL = milliliter
    • only use the dose cup provided
    adults and children 12 years and over30 mL every 4 hours
    children 6 to under 12 years15 mL every 4 hours
    children under 6 yearsdo not use
  • Other information

    • each 15 mL contains: sodium 13 mg
    • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
    • use by expiration date on package
  • Inactive ingredients

    anhydrous citric acid, FD&C yellow #6, flavors, glycerin, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sodium metabisulfite, sodium saccharin, sorbitol, sucralose

  • Questions or comments?

    1-800-426-9391

  • Principal display panel

    *Compare to the active
    ingredients in Vicks®
    DayQuil® Cold & Flu

    NDC 71141-179-32

    RELIEVES Headache,
    Fever, Sore Throat,
    Minor Aches & Pains,
    Nasal Congestion, Cough

    LIQUID

    Daytime
    cold & flu
    RELIEF

    Acetaminophen
    Pain Reliever/Fever Reducer
    Dextromethorphan HBr
    Cough Suppressant
    Phenylephrine HCl
    Nasal Decongestant

    Ages 6 Years
    and Over

    12 FL OZ (355 mL)

    by LIDL®

    TAMPER EVIDENT: DO NOT USE IF PRINTED
    NECK WRAP IS BROKEN OR MISSING

    PARENTS:
    Learn about teen medicine abuse
    www.StopMedicineAbuse.org

    *This product is not manufactured or distributed by The Procter & Gamble Company,
    owner of the registered trademark Vicks® DayQuil® Cold & Flu.
    50844          ORG032301202

    DISTRIBUTED BY
    LIDL US, LLC
    ARLINGTON, VA 22202
    1-844-344-5071
    www.lidl.com

    Lidl 44-012

    Lidl 44-012

  • INGREDIENTS AND APPEARANCE
    COLD AND FLU 
    acetaminophen, dextromethorphan hbr, phenylephrine hcl solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71141-179
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg  in 15 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 15 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 15 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    ColororangeScore    
    ShapeSize
    FlavorMENTHOLImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71141-179-32355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/07/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01207/07/2023
    Labeler - Lidl US LLC (079389709)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305manufacture(71141-179) , pack(71141-179)
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