ALKA SELTZER PLUS COLD DAY AND NIGHT EFFERVESCENT (ASPIRIN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE) TABLET [SINCRONIA LOGISTICA, S.A. DE C.V.]

ALKA SELTZER PLUS COLD DAY AND NIGHT EFFERVESCENT (ASPIRIN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE) TABLET [SINCRONIA LOGISTICA, S.A. DE C.V.]
PDF | XML

NDC 71992-154-20
Set ID c478df69-823a-4112-8f44-323249a9f38f
Category HUMAN OTC DRUG LABEL
Packager Sincronia Logistica, S.A. de C.V.
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
  • 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)

Related Drugs