Label: ALKA-SELTZER PLUS COLD DAY AND NIGHT POWERMAX GELS- acetaminophen, dextromethorphan hydrobromide, phenylephrine bitartrate, 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 March 13, 2023

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

  • SPL UNCLASSIFIED SECTION

    Alka-Seltzer Plus® Maximum Strength Sinus Congestion & Pain Day PowerMax® Gels

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each tablet)

    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 congestion

    · sinus congestion and pressure

    · 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

    liver disease ● heart disease ● high blood pressure

    ● thyroid disease ● diabetes

    ● cough that occurs 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 warfarin

  • 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

    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.

  • 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 SAFETY INFORMATION

    Other information

    ● store at room temperature. Avoid temperatures above 40ºC (104ºF).

  • SPL UNCLASSIFIED SECTION

    SPL

  • INACTIVE INGREDIENT

    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

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

  • Package Display Label

    ASP Plus 16Alka-Seltzer

    PLUS®

    Maximum Strength Sinus Congestion & Pain Day & Night PowerMax Gels

  • INGREDIENTS AND APPEARANCE
    ALKA-SELTZER PLUS COLD DAY AND NIGHT POWERMAX GELS 
    acetaminophen, dextromethorphan hydrobromide, phenylephrine bitartrate, doxylamine succinate kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0280-0099
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0280-0099-011 in 1 CARTON; Type 0: Not a Combination Product09/14/2018
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 12 CAPSULE 12 
    Part 21 CAPSULE
    Part 1 of 2
    ALKA-SELTZER PLUS MAXIMUM STRENGTH SINUS, CONGESTION AND PAIN POWER MAX GELS 
    acetaminophen, dextromethorphan hydrobromide , phenylephrine hydrochloride capsule, liquid filled
    Product Information
    Item Code (Source)NDC:0280-0095
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POTASSIUM ALUMINUM DISILICATE (UNII: SRB14JRX6C)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    SORBITAN (UNII: 6O92ICV9RU)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    GELATIN (UNII: 2G86QN327L)  
    POVIDONE (UNII: FZ989GH94E)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SORBITOL (UNII: 506T60A25R)  
    SHELLAC (UNII: 46N107B71O)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    Product Characteristics
    ColororangeScoreno score
    ShapeOVALSize17mm
    FlavorImprint Code ASP;CC
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    12 in 1 BLISTER PACK
    18 in 1 CAPSULE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34107/01/2021
    Part 2 of 2
    ALKA SELTZER PLUS MAXIMUM STRENGTH SINUS, ALLERGY AND COUGH POWER MAX GELS 
    acetaminophen, dextromethorphan hydrobromide , doxylamine succinate, phenylephrine hydrochloride capsule, liquid filled
    Product Information
    Item Code (Source)NDC:0280-0097
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
    DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE6.25 mg
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    SHELLAC (UNII: 46N107B71O)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    WATER (UNII: 059QF0KO0R)  
    POTASSIUM ALUMINUM DISILICATE (UNII: SRB14JRX6C)  
    SORBITAN (UNII: 6O92ICV9RU)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    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
    14 in 1 CAPSULE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34109/14/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34107/01/2018
    Labeler - Bayer HealthCare LLC. (112117283)