Label: NON DROWSY DAY COLD AND FLU PLUS AND NIGHTTIME COLD AND FLU PLUS- acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride kit

  • NDC Code(s): 68210-1111-2
  • Packager: Spirit Pharmaceuticals LLC
  • 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 March 11, 2020

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

  •  COLD & FLU FORMULA DAY NON-DROWSY Active ingredients (in each softgel)

    Acetaminophen 325 mg 
    Dextromethorphan hydrobromide 10 mg
    Phenylephrine hydrochloride 5 mg

  •  COLD & FLU FORMULA NIGHT Active ingredients (in each softgel)

    Acetaminophen 325 mg
    Dextromethorphan hydrobromide 10 mg
    Doxylamine succinate 6.25 mg
    Phenylephrine hydrochloride 5 mg

  • Purposes

    DAY COLD & FLU FORMULA

    Pain reliever/fever reducer

    Cough suppressant

    Nasal decongestant

  • Purposes

    NIGHT COLD & FLU FORMULA

    Pain reliever/fever reducer

    Cough suppressant

    Antihistamine

    Nasal decongestant

  • Uses

    DAY COLD & FLU FORMULA

    • temporarily relieves these symptoms due to a cold or flu:
      • minor aches and pains
      • headache
      • cough
      • sore throat
      • nasal and sinus congestion
    • temporarily reduces fever
  • Uses

    NIGHT COLD & FLU FORMULA

    • temporarily relieves these symptoms due to a cold or flu:
      • minor aches and pains
      • headache
      • nasal and sinus congestion
      • cough
      • sore throat
      • runny nose
      • sneezing
    • temporarily reduces fever

  • DAY COLD & FLU FORMULA Warnings 

    Liver warning

    These products contain acetaminophen. Severe liver damage may occur if you take

    • more than 10 softgels 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

    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.

    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.

    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
    • in children under 12 years of age  

    Ask a doctor before use if you have

    • liver disease
    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • cough with excessive phlegm (mucus)
    • difficulty in urination due to enlargement of the prostate gland
    • persistent or chronic cough such 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 exceed recommended dosage 

    Stop use and ask a doctor if

    • pain, cough, or nasal congestion 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.

    • nervousness, dizziness, or sleeplessness occurs  

     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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • NIGHTTIME COLD & FLU FORMULA Warnings

    Liver warning

    These products contain acetaminophen. Severe liver damage may occur if you take

    • more than 10 softgels 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

    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.

    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.

    Do not use to sedate children.

    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
    • in children under 12 years of age  

    Ask a doctor before use if you have

    • liver disease
    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • glaucoma 
    • cough with excessive phlegm (mucus)
    • a breathing problem such as emphysema or chronic bronchitis
    • difficulty in urination due to enlargement of the prostate gland
    • persistent or chronic cough such as occurs with smoking, asthma, or emphysema   

    Ask a doctor or pharmacist before use if you are

    • taking the blood thinning drug warfarin
    • taking sedatives or tranquilizers

    When using this product

    • do not exceed recommended dosage 
    • may cause marked drowsiness
    • avoid alcoholic drinks
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • be careful when driving a motor vehicle or operating machinery
    • excitability may occur, especially in children

    Stop use and ask a doctor if

    • pain, cough, or nasal congestion 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.

    • nervousness, dizziness, or sleeplessness occurs  

    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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • DAY COLD & FLU FORMULA Directions

    • do not take more than the recommended dose
    • adults and children 12 years and over: take 2 softgels with water every 4 hours. Do not exceed 10 softgels in 24 hours or as directed by a doctor.
    • children under 12 years: do not use
  • NIGHTTIME COLD & FLU FORMULA Directions

    • do not take more than the recommended dose
    • adults and children 12 years and over: take 2 softgels with water every 4 hours. Do not exceed 10 softgels in 24 hours or as directed by a doctor.
    • children under 12 years: do not use
  • DAY COLD & FLU FORMULA Other information

    • store at room temperature. Avoid excessive heat.
  • NIGHTTIME COLD & FLU FORMULA Other information

    • store at room temperature. Avoid excessive heat.
  • DAY COLD & FLU FORMULA Inactive ingredients 

    FD&C Red No. 40, FD&C Yellow No. 6, gelatin, glycerin, polyethylene
    glycol-400, povidone, propylene glycol, purified water, sorbitol sorbitan,
    titanium dioxide

  • NIGHTTIME COLD & FLU FORMULA Inactive ingredients 

    D&C Yellow No. 10, FD&C Blue No. 1, gelatin, glycerin, polyethylene
    glycol-400, povidone, propylene glycol, purified water, shellac, sorbitol
    sorbitan, sodium hydroxide, titanium dioxide

  • DAY COLD & FLU FORMULA

    Questions or comments?1-888-333-9792

  • NIGHTTIME COLD & FLU FORMULA

    Questions or comments?1-888-333-9792

  • PRINCIPAL DISPLAY PANEL

    Compare to the active ingredients in

    Alka-Seltzer PLUS® Day and Night Cold and Flu Formula

    NON-DROWSY DAY

    Cold & Flu Plus
    ACETAMINOPHEN- Pain reliever; Fever reducer
    DEXTROMETHORPHAN HBr - Cough suppressant
    PHENYLEPHRINE HCI - Nasal decongestant
    Relieves:
    Nasal congestion; Cough;
    Headache & body ache;
    Sore throat; Sinus pressure

    12 SOFTGELS

    NIGHTTIME

    Cold & Flu Plus

    ACETAMINOPHEN- Pain reliever; Fever reducer
    DEXTROMETHORPHAN HBr - Cough suppressant
    DOXYLAMINE SUCCINATE - Antihistamine
    PHENYLEPHRINE HCI - Nasal decongestant
    Relieves:
    Nasal congestion; Cough;
    Headache & body ache;
    Sore throat; Runny nose
    8 SOFTGELS

    *This product is not manufactured or distributed by Bayer Healthcare LLC, owner of the registered trademark

    Alka-Seltzer PLUS® Day and Night Cold and Flu Formula

    image description

  • INGREDIENTS AND APPEARANCE
    NON DROWSY DAY COLD AND FLU PLUS AND NIGHTTIME COLD AND FLU PLUS 
    acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68210-1111
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68210-1111-21 in 1 CARTON; Type 0: Not a Combination Product03/11/2020
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BLISTER PACK 12 
    Part 21 BLISTER PACK
    Part 1 of 2
    DAY COLD AND FLU PLUS 
    acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride capsule, liquid filled
    Product Information
    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)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POVIDONE (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Colororange (transparent) Scoreno score
    ShapeCAPSULE (oblong) Size21mm
    FlavorImprint Code 512
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    11 in 1 CARTON
    112 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34103/11/2020
    Part 2 of 2
    NIGHTTIME COLD AND FLU PLUS 
    acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride capsule, liquid filled
    Product Information
    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
    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)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POVIDONE (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    SHELLAC (UNII: 46N107B71O)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Colorgreen (transparent) Scoreno score
    ShapeCAPSULE (oblong) Size21mm
    FlavorImprint Code 116
    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 finalpart34106/05/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34103/11/2020
    Labeler - Spirit Pharmaceuticals LLC (179621011)
    Registrant - Spirit Pharmaceuticals LLC (179621011)
    Establishment
    NameAddressID/FEIBusiness Operations
    MEDGEL PRIVATE LTD677385498manufacture(68210-1111)