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

  • 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 October 9, 2020

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • SPL UNCLASSIFIED SECTION

    Alka-Seltzer Plus

    Maximum Strength Day & Night Cold & Flu Liquid Gels

  • ACTIVE INGREDIENT

    Active ingredients (in each capsule) Purposes

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

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

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

  • PURPOSE

  • INDICATIONS & USAGE

    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

    ● 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

    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.

  • 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

  • OTHER SAFETY INFORMATION

    Other information

    ● store at room temperature. Avoid excessive heat above 40°C

    (104°F).

  • INACTIVE INGREDIENT

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

  • QUESTIONS

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

  • SPL UNCLASSIFIED SECTION

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

  • 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

  • INDICATIONS & USAGE

    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

    ● 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

    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.

  • 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 excessive heat above 40°C

    (104°F).

  • INACTIVE INGREDIENT

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

  • QUESTIONS

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

  • PRINCIPAL DISPLAY PANEL

    Alka-Seltzer Plus®

    DAY NON-DROWSY

    ACETAMINOPHEN / Pain Reliever-Fever Reducer

    Dextromethorphan HBr / Cough Suppresant

    Phenylephrine HCl / Nasal Decongestant

    • Nasal Congestion
    • Headache & Body Ache
    • Cough
    • Sore Throat
    • Sinus Congestion

    12 LIQUID GELS

    (LIQUID-FILLED CAPSULES)

    Night

    ACETAMINOPHEN / Pain Reliever-Fever Reducer

    Dextromethorphan HBr / Cough Suppresant

    Doxylamine Succinate / Antihistamine

    Phenylephrine HCl / Nasal Decongestant

    • Nasal Congestion
    • Headache & Body Ache
    • Cough
    • Runny Nose
    • Sore Throat

    8 LIQUID GELS

    (LIQUID FILLED CAPSULES)

    Carton label

  • INGREDIENTS AND APPEARANCE
    ALKA-SELTZER PLUS MAXIMUM STRENGTH DAY AND NIGHT COLD AND FLU 
    dextromethorphan hydrobromide, acetaminophen, phenylephrine hydrochloride, doxylamine succinate kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0280-0040
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0280-0040-011 in 1 CARTON; Type 0: Not a Combination Product10/26/2020
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 10 BLISTER PACK
    Part 20 BLISTER PACK
    Part 1 of 2
    ALKA-SELTZER PLUS MAXIMUM STRENGTH DAY COLD AND FLU 
    dextromethorphan hydrobromide, acetaminophen, 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
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SHELLAC (UNII: 46N107B71O)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POVIDONE (UNII: FZ989GH94E)  
    SORBITAN (UNII: 6O92ICV9RU)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    Product Characteristics
    ColororangeScoreno score
    ShapeOVALSize20mm
    FlavorImprint Code AS;DC
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    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 finalpart341
    Part 2 of 2
    ALKA-SELTZER PLUS MAXIMUM STRENGTH NIGHT COLD AND FLU 
    dextromethorphan hydrobromide, acetaminophen, phenylephrine hydrochloride, doxylamine succinate 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
    DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE6.25 mg
    Inactive Ingredients
    Ingredient NameStrength
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    GELATIN (UNII: 2G86QN327L)  
    SORBITAN (UNII: 6O92ICV9RU)  
    SHELLAC (UNII: 46N107B71O)  
    SORBITOL (UNII: 506T60A25R)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POVIDONE (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Product Characteristics
    ColorgreenScoreno score
    ShapeOVALSize21mm
    FlavorImprint Code AS;NITE
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    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 finalpart34110/23/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34110/26/2020
    Labeler - Bayer HealthCare LLC. (112117283)