Label: ALKA SELTZER PLUS COLD DAY AND NIGHT EFFERVESCENT- aspirin, dextromethorphan hydrobromide, phenylephrine bitartrate tablet

  • NDC Code(s): 71992-154-20
  • Packager: Sincronia Logistica, S.A. de C.V.
  • Category: HUMAN OTC DRUG LABEL

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 4, 2021

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  • Drug Facts

  • Active ingredients (in each tablet)

    Aspirin 325 mg (NSAID)*

    Dextromethorphan hydrobromide 10 mg

    Phenylephrine bitartrate 7.8 mg

    *nonsteroidal anti-inflammatory drug

    Purposes

    Pain reliever/fever reducer

    Cough suppressant

    Nasal decongestant

  • Uses

    • temporarily relieves these symptoms due to a cold:

    • minor aches and pains • headache • runny nose

    • sinus congestion and pressure • cough • sneezing • sore throat

    • nasal congestion • temporarily reduces fever

  • Warnings

    Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s syndrome, a rare but serious illness.

    Allergy alert: Aspirin may cause a severe allergic reaction which may include:

    ● hives ● facial swelling ● asthma (wheezing) ● shock

    Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you

    ● are age 60 or older

    ● have had stomach ulcers or bleeding problems

    ● take a blood thinning (anticoagulant) or steroid drug

    ● take other drugs containing prescription or nonprescription NSAIDs

    (aspirin, ibuprofen, naproxen, or others)

    ● have 3 or more alcoholic drinks every day while using this product

    ● take more or for a longer time than directed

    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 

    ● if you are allergic to aspirin or any other pain reliever/fever reducer

    ● 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

    ● stomach bleeding warning applies to you

    ● you have a history of stomach problems, such as heartburn

    ● you have high blood pressure, heart disease, liver cirrhosis, or kidney  disease

    ● you are taking a diuretic

    ● you have

    ● asthma ● thyroid disease ● diabetes

    ● 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

    ● a sodium-restricted diet

    Ask a doctor or pharmacist before use if you are

    ● taking a prescription drug for

    ● gout ● diabetes ● arthritis

    ● taking sedatives or tranquilizers

    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 

    ● may cause problems in the unborn child or complications during delivery.

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away.

  • Directions

    ● adults and children 12 years and over: take 2 tablets fully dissolved in 4 oz of water at bedtime (may be taken every 4 to 6 hours). Do not exceed 8 tablets in 24 hours or as directed by a doctor.
    ● children under 12 years: do not use

  • Other information


    ● each tablet contains: sodium 476 mg
    ● Phenylketonurics: Contains Phenylalanine 5.6 mg Per Tablet

    ● store at room temperature. Avoid excessive heat.

  • Inactive ingredients

    acesulfame potassium, anhydrous citric acid, aspartame, calcium silicate, dimethicone, docusate sodium, flavors (natural & artificial), mannitol, povidone, sodium benzoate, sodium bicarbonate

  • Questions?

    1-800-986-0369 

  • Package Labeling:

    Outer PackageInner Package

  • INGREDIENTS AND APPEARANCE
    ALKA SELTZER PLUS COLD DAY AND NIGHT EFFERVESCENT 
    aspirin, dextromethorphan hydrobromide, phenylephrine bitartrate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71992-154
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN325 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
    PHENYLEPHRINE BITARTRATE (UNII: 27O3Q5ML57) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE BITARTRATE7.8 mg
    Inactive Ingredients
    Ingredient NameStrength
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    ASPARTAME (UNII: Z0H242BBR1)  
    CALCIUM SILICATE (UNII: S4255P4G5M)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DOCUSATE SODIUM (UNII: F05Q2T2JA0)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    MANNITOL (UNII: 3OWL53L36A)  
    POVIDONE (UNII: FZ989GH94E)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize25mm
    FlavorCITRUSImprint Code ASP;DAY
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71992-154-2020 in 1 CARTON; Type 0: Not a Combination Product07/02/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34107/02/2018
    Labeler - Sincronia Logistica, S.A. de C.V. (812799623)