Label: ALKA-SELTZER PLUS MAXIMUM STRENGTH COUGH, MUCUS AND CONGESTION DAY AND NIGHT- acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, guaifenesin, phenylephrine hydrochloride kit

  • NDC Code(s): 0280-0062-01
  • Packager: Bayer HealthCare, 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 May 28, 2020

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • SPL UNCLASSIFIED SECTION

    Do not take these products at the same time.

    Alka-Seltzer Plus® Maximum Strength Cough, Mucus & Congestion Day PowerMax® Gels

  • Active ingredients

    Active ingredients (in each capsule) Purposes

    Acetaminophen 325 mg…………….……….Pain reliever/fever reducer

    Dextromethorphan hydrobromide 10 mg…………..Cough suppressant

    Guaifenesin 200 mg…………………………………………..Expectorant

    Phenylephrine hydrochloride 5 mg………………...Nasal decongestant

  • PURPOSE

  • Uses

    Uses

    · helps loosen phlegm (mucus) and thin bronchial secretions to rid

    the bronchial passageways of bothersome mucus and make coughs

    more productive

    · temporarily relieves these symptoms due to a cold or flu:

    · nasal congestion · sinus congestion and pressure

    · minor aches and pains · headache

    · cough · sore throat

    · temporarily reduces fever

  • Warnings

    Warnings

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

    · more than 4,000 mg of acetaminophen in 24 hours

    · with other drugs containing acetaminophen

    · 3 or more alcoholic drinks every day while using this product

    Allergy alert: Acetaminophen may cause severe skin or severe

    allergic reactions. Symptoms may include:

    · skin reddening · blisters · rash · hives

    · facial swelling · asthma (wheezing) · shock

    If a skin or general allergic 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

    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

    Ask a doctor before use if you have

    ● liver disease ● heart disease ● high blood pressure

    ● thyroid disease ● diabetes

    ● difficulty in urination due to enlargement of the prostate gland

    ● persistent or chronic cough such as occurs with smoking, asthma,

    chronic bronchitis or emphysema

    ● cough with excessive phlegm (mucus)

    When using this product

    When using this product do not exceed recommended dosage

    Ask a doctor or pharmacist before use if you are

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

    Stop use and ask a doctor if

    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 fever, rash or headache that lasts.

    These could be signs of a serious condition.

    · nervousness, dizziness, or sleeplessness occurs

    If pregnant or breast-feeding

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

    Keep out of reach of children

    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.

  • Directions

    Directions

    · do not take more than the recommended dose

    · do not take the Day and Night products at the same time; wait 4 hours

    after the last Night dose before starting Day product

    · adults and children 12 years and over: take 2 capsules with water

    every 4 hours. Do not exceed 6 capsules in 12 hours or as

    directed by a doctor.

    · children under 12 years: do not use

  • Other information

    Other information

    · store at 15°- 25°C (59° - 77°F)

  • Inactive ingredients

    Inactive ingredients FD&C red No. 40, gelatin, glycerin, lecithin, medium chain triglycerides, polyethylene glycol, potassium aluminum silicate, povidone, propylene glycol, purified water, shellac, sodium hydroxide, sorbitol sorbitan solution, titanium dioxide

  • Questions or comments

    Questions or comments?1-800-986-0369 (Mon-Fri 9AM - 5PM EST)

  • SPL UNCLASSIFIED SECTION

    Alka-Seltzer Plus® Maximum Strength Cough, Mucus & Congestion Night PowerMax® Gels

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each capsule) Purposes

    Acetaminophen 325 mg…………….… ……...Pain reliever/fever reducer

    Dextromethorphan hydrobromide 10 mg…… ………Cough suppressant

    Doxylamine succinate 6.25 mg…………… ………………...Antihistamine

    Phenylephrine hydrochloride 5 mg.....…… ………...Nasal decongestant

  • PURPOSE

  • Uses

    Uses

    · 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

  • Warnings

    Warnings

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

    · more than 4,000 mg of acetaminophen in 24 hours

    · with other drugs containing acetaminophen

    · 3 or more alcoholic drinks every day while using this product

    Allergy alert: Acetaminophen may cause severe skin or severe allergic reactions. Symptoms may include:

    · skin reddening · blisters · rash · hives

    · facial swelling · asthma (wheezing) · shock

    If a skin or general allergic 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 to sedate children.

    Do not use

    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

    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

    Ask a doctor or pharmacist before use if you are

    ● taking the blood thinning drug warfarin

    ● taking sedatives or tranquilizers

    When using this product

    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

    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

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

    Keep out of reach of children

    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.

  • Directions

    Directions

    · do not take more than the recommended dose

    · do not take the Day and Night products at the same time; wait 4

    hours after the last Day dose before starting Night product

    · adults and children 12 years and over: take 2 capsules with water

    every 4 hours. Do not exceed 4 capsules in 12 hours or as

    directed by a doctor.

    · children under 12 years: do not use

  • Other information

    Other information

    · store at 15° - 25°C (59° - 77°F)

  • Inactive ingredients

    Inactive ingredients D&C yellow No. 10, FD&C blue No. 1, gelatin, glycerin, polyethylene glycol, potassium aluminum silicate, povidone, propylene glycol, purified water, shellac, sodium hydroxide, sorbitol sorbitan solution, titanium dioxide

  • Questions or comments

    Questions or comments? 1-800-986-0369 (Mon-Fri 9AM - 5PM EST)

  • Package label

    NEW

    Alka-Seltzer Plus®

    MAXIMUM STRENGTH

    Cough, Mucus &

    Congestion

    POWERMAX® GELS

    CONCENTRATED FORMULA

    DAY NON DROWSY

    ACETAMINOPHEN/ Pain Reliever Reducer
    Dextromethorphan HBr / Cough Suppressant

    Guaifenesin / Expectorant
    Phenyleprine HCl/ Nasal Decongestant

    • Nasal/Chest Congestion
    • Headache, Body Ache, Sore Throat, Fever
    • Cough
    • Mucus

    16 LIQUID GELS

    NIGHT

    ACETAMINOPHEN/ Pain Reliever Reducer
    Dextromethorphan HBr / Cough Suppressant

    Doxylamine Succinate/ Antihistamine
    Phenyleprine HCl/ Nasal Decongestant

    • Nasal/Chest Congestion
    • Headache, Body Ache, Sore Throat, Fever
    • Runny Nose, Sneezing
    • Cough

    8 LIQUID GELS: 24 TOTAL

    Carton label 24 count

  • INGREDIENTS AND APPEARANCE
    ALKA-SELTZER PLUS MAXIMUM STRENGTH COUGH, MUCUS AND CONGESTION DAY AND NIGHT 
    acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, guaifenesin, phenylephrine hydrochloride kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0280-0062
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0280-0062-011 in 1 CARTON; Type 0: Not a Combination Product06/01/2020
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 13 BLISTER PACK
    Part 21 BLISTER PACK
    Part 1 of 2
    ALKA-SELTZER PLUS MAXIMUM STRENGTH COUGH, MUCUS AND CONGESTION DAY POWERMAX 
    acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride capsule, liquid filled
    Product Information
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    POTASSIUM ALUMINUM DISILICATE (UNII: SRB14JRX6C)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    GELATIN (UNII: 2G86QN327L)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    POVIDONE (UNII: FZ989GH94E)  
    WATER (UNII: 059QF0KO0R)  
    SHELLAC (UNII: 46N107B71O)  
    SORBITAN (UNII: 6O92ICV9RU)  
    SORBITOL (UNII: 506T60A25R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorredScoreno score
    ShapeOVAL (ELLIPTICAL) Size20mm
    FlavorImprint Code ASP;S
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    12 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34106/01/2020
    Part 2 of 2
    ALKA-SELTZER PLUS MAXIMUM STRENGTH COUGH, MUCUS AND CONGESTION NIGHT POWERMAX 
    acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride capsule, liquid filled
    Product Information
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE6.25 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    POVIDONE (UNII: FZ989GH94E)  
    SHELLAC (UNII: 46N107B71O)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SORBITAN (UNII: 6O92ICV9RU)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    GELATIN (UNII: 2G86QN327L)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SORBITOL (UNII: 506T60A25R)  
    POTASSIUM ALUMINUM DISILICATE (UNII: SRB14JRX6C)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorgreenScoreno score
    ShapeOVAL (ELLIPTICAL) Size17mm
    FlavorImprint Code ASP;N
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    12 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34106/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34106/01/2020
    Labeler - Bayer HealthCare, LLC. (112117283)