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

  • 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 June 19, 2017

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

  • SPL UNCLASSIFIED SECTION

    Do not take these products at the same time.

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • SPL UNCLASSIFIED SECTION

    Alka-Seltzer Plus® Maximum Strength Severe Sinus Congestion & Cough Day Liquid Gels

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  • ACTIVE INGREDIENT

    Active ingredients (in each capsule)
    Acetaminophen 325 mg
    Dextromethorphan hydrobromide 10 mg

    Phenylephrine hydrochloride 5 mg

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  • PURPOSE

    Purposes
    Pain reliever/fever reducer
    Cough suppressant

    Nasal decongestant

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  • INDICATIONS & USAGE

    Uses
    · temporarily relieves these symptoms due to a cold or flu:
    · nasal congestion · sinus congestion and pressure
    · headache · minor aches and pains
    · cough · sore throat
    · helps clear nasal passages and shrinks swollen membranes

    · temporarily reduces fever

    Close
  • 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.

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  • 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

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  • 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

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  • ASK DOCTOR/PHARMACIST

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

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  • WHEN USING

    When using this product do not exceed recommended dosage

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  • 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

    Close
  • PREGNANCY OR BREAST FEEDING

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

    Close
  • 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.

    Close
  • 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

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  • Other information

    Other information

    · store at room temperature. Avoid excessive heat above 40ºC

    (104ºF).

    Close
  • INACTIVE INGREDIENT

    Inactive ingredients FD&C yellow #6, FD&C red #40, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sodium hydroxide, sorbitol sorbitan solution, titanium dioxide

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  • Questions or comments?

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

    Close
  • SPL UNCLASSIFIED SECTION

    Alka-Seltzer Plus® Maximum Strength Severe Sinus Congestion & Cough Night Liquid Gels

    Close
  • SPL UNCLASSIFIED SECTION

    Drug Facts

    Close
  • ACTIVE INGREDIENT

    Active ingredients (in each capsule)

    Acetaminophen 325 mg

    Dextromethorphan hydrobromide 10 mg

    Doxylamine succinate 6.25 mg

    Phenylephrine hydrochloride 5 mg

    Close
  • INDICATIONS & USAGE

    Uses

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

    · nasal congestion · sinus congestion and pressure

    · headache · minor aches and pains

    · cough · sore throat

    · runny nose · sneezing

    · helps clear nasal passages and shrinks swollen membranes

    · temporarily reduces fever

    Close
  • 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.

    Close
  • 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

    Close
  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are

    ● taking the blood thinning drug warfarin

    ● taking sedatives or tranquilizers

    Close
  • 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

    Close
  • 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

    Close
  • PREGNANCY OR BREAST FEEDING

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

    Close
  • 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.

    Close
  • DOSAGE & ADMINISTRATION

    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

    Close
  • Other information

    Other information

    · store at room temperature. Avoid excessive heat above 40ºC

    (104ºF).

    Close
  • INACTIVE INGREDIENT

    Inactive ingredients FD&C blue #1, D&C yellow #10, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sodium hydroxide, sorbitol sorbitan solution, titanium dioxide

    Close
  • Questions or comments?

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

    Close
  • INGREDIENTS AND APPEARANCE
    ALKA-SELTZER PLUS MAXIMUM STRENGTH SEVERE SINUS CONGESTION AND COUGH DAY AND NIGHT 
    acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride kit
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0280-1610
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0280-1610-20 1 in 1 CARTON; Type 0: Not a Combination Product 06/12/2017
    Quantity of Parts
    Part # Package Quantity Total Product Quantity
    Part 1 2 BLISTER PACK 12 
    Part 2 4 BLISTER PACK 16 
    Part 1 of 2
    ALKA-SELTZER PLUS MAXIMUM STRENGTH SEVERE SINUS CONGESTION AND COUGH DAY 
    acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride capsule, liquid filled
    Product Information
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg
    Inactive Ingredients
    Ingredient Name Strength
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    SHELLAC (UNII: 46N107B71O)  
    SORBITAN (UNII: 6O92ICV9RU)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GELATIN (UNII: 2G86QN327L)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Product Characteristics
    Color orange Score no score
    Shape OVAL Size 20mm
    Flavor Imprint Code AS;SC
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 2 in 1 CARTON
    1 6 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 06/12/2017
    Part 2 of 2
    ALKA-SELTZER PLUS MAXIMUM STRENGTH SEVERE SINUS CONGESTION AND COUGH NIGHT 
    acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride capsule, liquid filled
    Product Information
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg
    DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE 6.25 mg
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SHELLAC (UNII: 46N107B71O)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POVIDONE (UNII: FZ989GH94E)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    SORBITOL (UNII: 506T60A25R)  
    SORBITAN (UNII: 6O92ICV9RU)  
    Product Characteristics
    Color green Score no score
    Shape OVAL Size 20mm
    Flavor Imprint Code AS;SC
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 2 in 1 CARTON
    1 4 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 06/12/2017
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 06/12/2017
    Labeler - Bayer HealthCare LLC. (112117283)
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