Label: KROGER DAYTIME AND NIGHTTIME COLD AND FLU SOFTGEL- acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride, doxylamine succinate kit

  • 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 July 22, 2023

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

  • DayTime Cold & Flu

    Drug Facts

  • Active ingredients (in each Softgel)

    Acetaminophen 325 mg

    Dextromethorphan HBr 10 mg

    Phenylephrine HCl 5 mg

  • Purposes

    Pain reliever / Fever reducer

    Cough suppressant

    Nasal decongestant

  • Uses:

    temporarily relieves common cold/flu symptoms:
    • nasal congestion • cough due to minor throat & bronchial irritation • sore throat  • headache • minor aches & pains • fever

  • Warnings:

    Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take • more than 4 doses in 24 hrs, 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 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, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, see 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  • high blood pressure • thyroid disease  • diabetes  • trouble urinating due to enlarged prostate gland  • cough that occurs with too much phlegm (mucus)  • persistent or chronic cough as occurs with smoking, asthma, or emphysema

    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  • pain, nasal congestion or cough get worse or last 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 (1-800-222-1222). Quick medical attention is critical for adults & for 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 hrs
       adults & children 12 yrs & over 2 Softgels with water every 4 hrs
       children 4 to under 12 yrs ask a doctor
       children under 4 yrs do not use

  • Other information:

    • store at room temperature between 20-25 °C (68-77 °F)
  • Inactive ingredients:

    Edible white ink, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol 400, povidone, propylene glycol, purified water, sorbitol sorbitan solution

  • Questions or comments:

    1-800-632-6900

  • NightTime Cold & Flu

    Drug Facts

  • Active ingredients (in each Softgel)

    Acetaminophen 325 mg

    Dextromethorphan HBr 15 mg

    Doxylamine succinate 6.25 mg

  • Purposes

    Pain reliever / Fever reducer

    Cough suppressant

    Antihistamine

  • Uses:

    temporarily relieves common cold/flu symptoms:
    • cough due to minor throat & bronchial irritation   • sore throat  • headache  • minor aches & 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 hrs, 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 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.  • 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 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 • 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 (1-800-222-1222). Quick medical attention is critical for adults & for 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 hrs
     adults & children 12 yrs & over 2 Softgels with water every 6 hrs
     children 4 to under 12 yrs ask a doctor
     children under 4 yrs do not use

  • Other information:

    • store at room temperature between 20-25 °C (68-77 °F)
  • Inactive ingredients:

    D&C yellow #10, edible white ink, FD&C blue #1, gelatin, glycerin, polyethylene glycol 400, povidone, propylene glycol, purified water, sorbitol sorbitan solution

  • Questions or comments:

    1-800-632-6900

  • SPL UNCLASSIFIED SECTION

    COMPARE TO the active ingredients of VICKS® DAYQUIL®/NYQUIL® COLD & FLU RELIEF LIQUICAPS® ​*See side panel

    POWERFUL RELIEF

    DAYTIME OR NIGHT TIME

    OUR PHARMACIST RECOMMENDED

    Multi-Symptom Relief

    READ AND KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

    DO NOT USE IF THE BLISTER IS TORN OR BROKEN OR SHOW ANY SIGNS OF TAMPERING

    DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202

    MADE IN UAE

    For More Product Information, Scan UPC

    Using Your Kroger App or Call 800-632-6900

    Our Brands, Our Gurantee.

    Love It or Your Money Back.

    www.kroger.com

    PARENTS:

    Learn about teen medicine abuse

    www.StopMedicineAbuse.org

    *This product is not manufactured or distributed by The Proctor & Gamble Company. Vicks®, DayQuil®, NyQuil®, and LiquiCaps® are registered trademarks of The Proctor & Gamble Company.

  • Packaging

    image

  • INGREDIENTS AND APPEARANCE
    KROGER DAYTIME AND NIGHTTIME COLD AND FLU SOFTGEL 
    acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride, doxylamine succinate kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30142-233
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:30142-233-741 in 1 KIT; Type 0: Not a Combination Product08/31/2022
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 14 BLISTER PACK 32 
    Part 24 BLISTER PACK 16 
    Part 1 of 2
    KROGER DAYTIME COLD AND FLU SOFTGEL 
    acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride capsule, liquid filled
    Product Information
    Item Code (Source)NDC:30142-087
    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)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    SORBITAN (UNII: 6O92ICV9RU)  
    Product Characteristics
    ColorredScoreno score
    ShapeOVALSize21mm
    FlavorImprint Code 807
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    18 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34108/31/2022
    Part 2 of 2
    KROGER NIGHTTIME COLD AND FLU SOFTGEL 
    acetaminophen, dextromethorphan hydrobromide, doxylamine succinate capsule, liquid filled
    Product Information
    Item Code (Source)NDC:30142-086
    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 HYDROBROMIDE15 mg
    DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE6.25 mg
    Inactive Ingredients
    Ingredient NameStrength
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    SORBITAN (UNII: 6O92ICV9RU)  
    Product Characteristics
    ColorgreenScoreno score
    ShapeOVALSize21mm
    FlavorImprint Code 808
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    14 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34108/31/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34108/31/2022
    Labeler - The Kroger Company (006999528)