Label: ALKA-SELTZER PLUS MAXIMUM STRENGTH COUGH AND MUCUS DM- dextromethorphan hydrobromide, guaifenesin tablet, extended release

  • NDC Code(s): 0280-1660-07, 0280-1660-14, 0280-1660-28
  • Packager: Bayer HealthCare LLC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated April 22, 2021

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients

    Dextromethorphan HBr 60 mg

    Guaifenesin 1200 mg

  • PURPOSE

    Purposes (in each extended-release tablet)

    Cough suppressant

    Expectorant

  • 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:

    · cough due to minor throat and bronchial irritation as may occur with

    the common cold or inhaled irritants

    · the intensity of coughing

    · the impulse to cough to help you get to sleep

  • WARNINGS

    Warnings
    Do not use

    · for children under 12 years of age

    · 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.

  • ASK DOCTOR

    Ask a doctor before use if you have

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

    chronic bronchitis, or emphysema

    · cough accompanied by too much phlegm (mucus)

  • WHEN USING

    When using this product do not use more than directed

  • STOP USE

    Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness.

  • 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 (1-800-222-1222).

  • Directions

    Directions

    · do not crush, chew, or break tablet

    · take with a full glass of water

    · this product can be administered without regard for timing of meals

    · adults and children 12 years and older: 1 tablet every 12 hours; not

    more than 2 tablets in 24 hours

    · children under 12 years of age: do not use

  • Other information

    Other information

    · each tablet contains: magnesium 25 mg

    · store between 20-25ºC (68-77ºF)

  • INACTIVE INGREDIENT

    Inactive ingredients carbomer homopolymer type B, copovidone, D&C yellow #10 aluminum lake, hypromellose, magnesium hydroxide, magnesium stearate, microcrystalline cellulose, silicon dioxide

  • Questions or comments?

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

  • PRINCIPAL DISPLAY PANEL

    New!

    Alka-Seltzer Plus® MAXIMUM STRENGTH

    Cough & Mucus DM

    12 HOUR EXTENDED-RELEASE TABLETS

    Guaifenesin 1200 mg / Expectorant

    Dextromethorphan Hydrobromide 60 mg / Cough Suppresant

    • Controls Cough
    • This and Loosens Mucus

    14 EXTENDED-RELEASE TABLETS

    Carton 14 count

  • INGREDIENTS AND APPEARANCE
    ALKA-SELTZER PLUS MAXIMUM STRENGTH COUGH AND MUCUS DM 
    dextromethorphan hydrobromide, guaifenesin tablet, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0280-1660
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE60 mg
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN1200 mg
    Inactive Ingredients
    Ingredient NameStrength
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)  
    MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    COPOVIDONE (UNII: D9C330MD8B)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    Product Characteristics
    ColoryellowScoreno score
    ShapeOVALSize21mm
    FlavorImprint Code AS;M
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0280-1660-142 in 1 CARTON07/02/201806/30/2022
    17 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:0280-1660-284 in 1 CARTON07/02/201809/30/2020
    27 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:0280-1660-071 in 1 CARTON10/02/201802/28/2021
    37 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20760207/02/201806/30/2022
    Labeler - Bayer HealthCare LLC. (112117283)