Label: ALKA-SELTZER PLUS MAXIMUM STRENGTH DAY AND NIGHT COLD AND FLU POWERMAX GELS- acetaminophen, dextrmethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride kit

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated August 20, 2024

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • PATIENT PACKAGE INSERT

    Do not take these products at the same time.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • SPL UNCLASSIFIED SECTION

    Alka-Seltzer Plus® Maximum Strength Day Cold & Flu PowerMax™ Gels

  • ACTIVE INGREDIENT

    Active ingredients (in each capsule)

    Acetaminophen 325 mg

    Dextromethorphan hydrobromide 10 mg

    Phenylephrine hydrochloride 5 mg

  • PURPOSE

    Purposes

    Pain reliever/fever reducer

    Cough suppressant

    Nasal decongestant

  • Uses

    Uses

    · 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

  • 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 DOCTOR

    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 DOCTOR/PHARMACIST

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

  • WHEN USING

    When using this product do not exceed recommended dosage

  • STOP USE

    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

  • PREGNANCY OR BREAST FEEDING

    IIf 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

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

    every 4 hours. Do not exceed 10 capsules in 24 hours or as

    directed by a doctor.

    · children under 12 years: do not use

  • Other information

    Other information

    ● store at room temperature. Avoid temperatures above 25°C (77°F).

  • INACTIVE INGREDIENT

    Inactive ingredients FD&C yellow #6, ferric oxide, 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)

  • SPL UNCLASSIFIED SECTION

    Alka-Seltzer Plus® Maximum Strength Night Cold & Flu PowerMax™ Gels

  • ACTIVE INGREDIENT

    Active ingredients (in each capsule)

    Acetaminophen 325 mg

    Dextromethorphan hydrobromide 10 mg

    Doxylamine succinate 6.25 mg

    Phenylephrine hydrochloride 5 mg

  • PURPOSE

    Purposes

    Pain reliever/fever reducer

    Cough suppressant

    Antihistamine

    Nasal decongestant

  • 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 DOCTOR

    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 DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are

    ● taking the blood thinning drug warfarin

    ● taking sedatives or tranquilizers

  • WHEN USING

    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

  • WHEN USING

    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

  • PREGNANCY 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

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

    every 4 hours. Do not exceed 10 capsules in 24 hours or as

    directed by a doctor.

    · children under 12 years: do not use

  • Other information

    Other information

    ● store at room temperature. Avoid temperatures above 25°C (77°F).

  • INACTIVE INGREDIENT

    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)

  • PRINCIPAL DISPLAY PANEL

    PDP

  • INGREDIENTS AND APPEARANCE
    ALKA-SELTZER PLUS MAXIMUM STRENGTH DAY AND NIGHT COLD AND FLU POWERMAX GELS 
    acetaminophen, dextrmethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0280-1680
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0280-1680-241 in 1 CARTON; Type 0: Not a Combination Product07/02/2018
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 12 BLISTER PACK 16 
    Part 21 BLISTER PACK 8   in 2 
    Part 1 of 2
    ALKA-SELTZER PLUS MAXIMUM STRENGTH DAY COLD AND FLU POWERMAX GELS 
    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) PHENYLEPHRINE HYDROCHLORIDE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SORBITAN (UNII: 6O92ICV9RU)  
    SORBITOL (UNII: 506T60A25R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    WATER (UNII: 059QF0KO0R)  
    SHELLAC (UNII: 46N107B71O)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    POVIDONE (UNII: FZ989GH94E)  
    Product Characteristics
    ColororangeScoreno score
    ShapeOVALSize16mm
    FlavorImprint Code ASP;DC
    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 DrugM01207/02/2018
    Part 2 of 2
    ALKA-SELTZER PLUS MAXIMUM STRENGTH NIGHT COLD AND FLU POWERMAX GELS 
    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
    DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE6.25 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    SORBITOL (UNII: 506T60A25R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    SHELLAC (UNII: 46N107B71O)  
    SORBITAN (UNII: 6O92ICV9RU)  
    Product Characteristics
    ColorgreenScoreno score
    ShapeOVALSize16mm
    FlavorImprint Code ASP;N
    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 DrugM01207/02/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01207/02/2018
    Labeler - Bayer HealthCare LLC. (112117283)