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

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

Drug Label Information

Updated December 6, 2023

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

  • Active ingredients (in each softgel)

    Equate Health COLD & FLU FORMULA DAY NON-DROWSY

    Acetaminophen 325 mg
    Dextromethorphan hydrobromide 10 mg
    Phenylephrine hydrochloride 5 mg

    Equate Health COLD & FLU FORMULA NIGHT

    Acetaminophen 325 mg
    Dextromethorphan hydrobromide 10 mg
    Phenylephrine hydrochloride 5 mg

  • Purposes

    DAY COLD & FLU FORMULA

    Pain reliever/fever reducer

    Cough suppressant

    Nasal decongestant

    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

    NIGHT COLD & FLU FORMULA

    Pain reliever/fever reducer

    Cough suppressant

    Antihistamine

    Nasal decongestant

  • undefined

    Liver warning

    DAY COLD & FLU FORMULA

    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.

    NIGHTTIME COLD & FLU FORMULA

    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

    DAY COLD & FLU FORMULA

    • 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

    NIGHTTIME COLD & FLU FORMULA

    • 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

    DAYTIME COLD & FLU FORMULA

    • 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

    NIGHTTIME COLD & FLU FORMULA

    • 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

    DAYTIME COLD & FLU FORMULA

    Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

    NIGHTTIME COLD & FLU FORMULA

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

    When using this product

    DAYTIME COLD & FLU FORMULA

    When using this product do not exceed recommended dosage

    NIGHTTIME COLD & FLU FORMULA

    • 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

    DAYTIME COLD & FLU FORMULA

    • 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

    NIGHTTIME COLD &FLU  FORMULA

    • 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.

    If pregnant or breast-feeding, ask a health professional before use.

  • Directions

    DAY COLD & FLU FORMULA

    • 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

    • 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
  • Other information

    • store at room temperature. Avoid excessive heat.
  • Inactive ingredients

    DAY COLD & FLU FORMULA

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

    NIGHTTIME COLD & FLU FORMULA

    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

  • Questions or comments?

    1-888-287-1915

  • Principal Display Panel

    Equate NON-DROWSY DAY Cold & Flu Formula and NIGHTTIME Cold & Flu Formula 20ct


    Compare to the active ingredients in

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


    NON-DROWSY DAY

    Cold & Flu Formula

    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 Formula

    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 PACKAGED IN A CHILD-RESISTANT AND

    TAMPER-EVIDENT PACKAGE. USE ONLY IF BLISTERS ARE INTACT

    *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

    Carton

  • INGREDIENTS AND APPEARANCE
    EQUATE HEALTH 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:79903-133
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79903-133-201 in 1 CARTON; Type 1: Convenience Kit of Co-Package08/11/2022
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BLISTER PACK 12 
    Part 21 BLISTER PACK
    Part 1 of 2
    EQUATE HEALTH DAY COLD AND FLU PLUS 
    acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride capsule, liquid filled
    Product Information
    Item Code (Source)NDC:79903-149
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE5 mg
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 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)  
    SORBITOL (UNII: 506T60A25R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorredScoreno score
    ShapeOVALSize21mm
    FlavorImprint Code 512;A09
    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 DrugM01208/11/2022
    Part 2 of 2
    EQUATE HEALTH NIGHTTIME COLD AND FLU PLUS 
    acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride capsule, liquid filled
    Product Information
    Item Code (Source)NDC:79903-150
    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)  
    SORBITOL (UNII: 506T60A25R)  
    SORBITAN (UNII: 6O92ICV9RU)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorgreenScoreno score
    ShapeOVALSize21mm
    FlavorImprint Code 116;A07
    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 DrugM01208/11/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01208/11/2022
    Labeler - Wal-Mart Stores Inc (051957769)