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

  • NDC Code(s): 68210-5015-2
  • Packager: Spirit Pharmaceuticals LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 11, 2024

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

  • Active ingredients (in each softgel)

    COLD & FLU NON-DROWSY DAY RELIEF 

    Acetaminophen 325 mg
    Dextromethorphan hydrobromide 10 mg
    Phenylephrine hydrochloride 5 mg

    COLD & FLU NIGHT RELIEF

    Acetaminophen 325 mg
    Dextromethorphan hydrobromide 10 mg

    Doxylamine succinate 6.25 mg

  • Purposes

    COLD & FLU NON DROWSY DAY RELIEF

    Pain reliever/fever reducer

    Cough suppressant

    Nasal decongestant

    COLD & FLU NIGHT RELIEF

    Pain reliever/fever reducer

    Cough suppressant

    Antihistamine

  • Uses

    temporarily relieves common cold/flu symptoms:

    • fever
    • headache
    • minor aches and pain
    • cough due to minor throat and bronchial iffitation
    • sore throat
    • nasal congestion (Daytime only)
    • runny nose and sneezing (Nighttime only)
  • 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 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● to make a child sleepy (Nighttime only)

    Ask a doctor before use if you have

    ● cough that occurs with too much phlegm (mucus) ● liver disease
    ● trouble urinating due to enlarged prostate gland
    ● diabetes (Daytime only) ● heart disease (Daytime only)
    ● thyroid disease (Daytime only) ● high blood pressure (Daytime only)
    ● persistent or chronic cough such as occurs with smoking, asthma, or emphysema (Daytime only)
    ● a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema (Nighttime only)
    ● glaucoma (Nighttime only)

    Ask a doctor or pharmacist before use if you are

    ● taking the blood thinning drug warfarin
    ● taking sedatives or tranquilizers (Nighttime only)

    When using this product

    ● do not take more than directed
    ● marked drowsiness may occur (Nighttime only)
    ● avoid alcoholic drinks (Nighttime only)
    ● excitability may occur, especially in children (Nighttime only)
    ● be careful when driving a motor vehicle or operating machinery (Nighttime only)
    ● alcohol, sedatives, and tranquilizers may increase drowsiness (Nighttime only)

    Stop use and ask a doctor if

    ● you get nervous, dizzy or sleepless (Daytime only)
    ● pain, nasal congestion, or cough gets worse or lasts more than 7 days (Daytime only)
    ● pain or cough gets worse or lasts more than 7 days (Nighttime only)
    ● 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. Quick medical attention is critical for adults & for children even if you do not notice any signs or symptoms.

  • Directions

    ● when using other DAYTIME and NIGHTTIME products, carefully read each
    label to ensure correct dosing

    Directions (Daytime only)
    ● take only as directed - see Overdose warning
    ● do not exceed 4 doses per 24 hours

    adults & children 12 years & overtake 2 softgels with water every 4 hours
    children 4 to under 12 yearsask a doctor
    children under 4 years of agedo not use

     ● when using other DAYTIME and NIGHTTIME products, carefully read each label to ensure correct dosing

    Directions (Nighttime only)

    ● take only as directed - see Overdose warning
    ● do not exceed 4 doses per 24 hours

    adults & children 12 years & overtake 2 softgels with water every 6 hours
    children 4 to under 12 yearsask a doctor
    children under 4 years of agedo not use

  • Other information

    • store at room temperature.
  • Inactive ingredients

    DAYTIME

    FD&C Red# 40, FD&C Yellow# 6, gelatin, glycerin, polyethylene glycol, lecithin, myglyol, povidone, propylene glycol, purified water, sorbitol sorbitan, titanium dioxide 

    NIGHTTIME

    D&C Yellow# 10, FD&C Blue# 1, gelatin, glycerin, myglyol, lecithin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan, polysorb, sorbitol sorbitan, titanium dioxide

  • Questions or comments?

    1-888-333-9792

  • SPL UNCLASSIFIED SECTION

    Distributed By:
    Spirit Pharmaceuticals, LLC
    Ronkonkoma, NY 11779

    REV 02/23

    Made in India

  • Principal Display Panel

    Day Night 24 ct CmdoCarton

  • INGREDIENTS AND APPEARANCE
    DAYTIME NON DROWS COLD AND FLU AND NIGHTTIME COLD AND 
    acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68210-5015
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68210-5015-21 in 1 CARTON; Type 1: Convenience Kit of Co-Package05/26/2023
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BLISTER PACK
    Part 21 BLISTER PACK
    Part 1 of 2
    DAYTIME NON DROWSY COLD AND FLU 
    acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride capsule, liquid filled
    Product Information
    Item Code (Source)NDC:68210-5013
    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) PHENYLEPHRINE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POVIDONE (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SORBITOL (UNII: 506T60A25R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorredScoreno score
    ShapeOVALSize21mm
    FlavorImprint Code 512;A09;AP01
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    12 in 1 CARTON
    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 DrugM01205/26/2023
    Part 2 of 2
    NIGHTTIME COLD AND FLU 
    acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride capsule, liquid filled
    Product Information
    Item Code (Source)NDC:68210-5014
    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
    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 (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POVIDONE (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SORBITOL (UNII: 506T60A25R)  
    SORBITAN (UNII: 6O92ICV9RU)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorgreenScoreno score
    ShapeOVALSize21mm
    FlavorImprint Code 116;A07;AP02
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    11 in 1 CARTON
    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 DrugM01205/26/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01205/26/2023
    Labeler - Spirit Pharmaceuticals LLC (179621011)