Label: ALKA-SELTZER PLUS DAY AND NIGHT COLD- alka-seltzer plus day and night cold

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 December 8, 2017

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

  • Alka-Seltzer Plus Day Non-Drowsy Cold Effervescent Tablets

    Alka-Seltzer Plus Day Non-Drowsy Cold Effervescent Tablets

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  • Drug Facts

    Drug Facts

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  • Active ingredients (in each tablet)

    *
    nonsteroidal anti-inflammatory drug
    Active ingredients (in each tablet) Purposes
    Aspirin 325 mg (NSAID) * Pain reliever/fever reducer
    Dextromethorphan hydrobromide 10 mg Cough suppressant
    Phenylephrine bitartrate 7.8 mg Nasal decongestant

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  • Uses

    · temporarily relieves these symptoms due to a cold with cough:

    · minor aches and pains · headache · cough

    · nasal and sinus congestion · sore throat

    · temporarily reduces fever

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  • 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.

    Close
  • 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
    Close
  • 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)

    ● 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

    Close
  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are

    ● taking a prescription drug for

    · gout · diabetes · arthritis

    Close
  • WHEN USING

    When using this product do not exceed recommended dosage

    Close
  • Stop use and ask a doctor if

    Stop use and ask a doctor if

    • an allergic reaction occurs. Seek medical help right away.
    • you experience any of the following signs of stomach bleeding

    ● feel faint ● vomit blood ● have bloody or black stools

    ● have stomach pain that does not get better

    • 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
    • ringing in the ears or loss of hearing occurs
    • cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.
    • nervousness, dizziness, or sleeplessness occurs
    Close
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

    It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

    Close
  • 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.

    Close
  • Directions

    Directions

    ● adults and children 12 years and over: take 2 tablets fully dissolved in 4 oz of water every 4 hours. Do not exceed 8 tablets in 24 hours or as directed by a doctor.

    ● children under 12 years: do not use

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  • Other information

    ● each tablet contains: sodium 416 mg
    ● Phenylketonurics: Contains Phenylalanine 9 mg Per Tablet

    ● store at room temperature. Avoid excessive heat.

    Close
  • Inactive ingredients

    acesulfame potassium, anhydrous citric acid, aspartame, calcium silicate, dimethylpolysiloxane, docusate sodium, flavors, mannitol, povidone, sodium benzoate, sodium bicarbonate

    Close
  • QUESTIONS

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

    Close
  • Alka-Seltzer Plus® Night Cold Effervescent Tablets

    Alka-Seltzer Plus® Night Cold Effervescent Tablets

    Close
  • Drug Facts
  • Active ingredients (in each tablet)

    *
    nonsteroidal anti-inflammatory drug
    Active ingredients (in each tablet) Purposes
    Aspirin 500 mg (NSAID) * Pain reliever/fever reducer
    Dextromethorphan hydrobromide 10 mg Cough suppressant
    Doxylamine succinate 6.25 mg Antihistamine
    Phenylephrine bitartrate 7.8 mg Nasal decongestant

    Close
  • INDICATIONS & USAGE

    · 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

    Close
  • 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.

    Close
  • 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
    Close
  • ASK DOCTOR

    ● 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 ● diabetes ● thyroid disease ● 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

    ● a sodium-restricted diet

    Close
  • Ask a doctor or pharmacist before use if you are

    Ask a doctor or pharmacist before use if you are

    · taking a prescription drug for

    · gout · diabetes · arthritis

    · taking sedatives or tranquilizers

    Close
  • WHEN USING

    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 operating machinery
    • excitability may occur, especially in children
    Close
  • STOP USE

    Stop use and ask a doctor if

    • an allergic reaction occurs. Seek medical help right away.
    • you experience any of the following signs of stomach bleeding

    ● feel faint ● vomit blood ● have bloody or black stools

    ● have stomach pain that does not get better

    • 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
    • ringing in the ears or loss of hearing occurs
    • cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.
    • nervousness, dizziness, or sleeplessness occurs
    Close
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

    It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

    Close
  • 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.

    Close
  • 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

    Close
  • OTHER SAFETY INFORMATION

    ● each tablet contains: sodium 474 mg
    ● Phenylketonurics: Contains Phenylalanine 5.6 mg Per Tablet

    ● store at room temperature. Avoid excessive heat.

    Close
  • INACTIVE INGREDIENT

    acesulfame potassium, anhydrous citric acid, aspartame, calcium silicate, dimethylpolysiloxane, docusate sodium, flavors, mannitol, povidone, sodium benzoate, sodium bicarbonate

    Close
  • QUESTIONS

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

    Close
  • INGREDIENTS AND APPEARANCE
    ALKA-SELTZER PLUS  DAY AND NIGHT COLD
    alka-seltzer plus day and night cold kit
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0280-1140
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0280-1140-20 1 in 1 CARTON 01/09/2015 11/01/2018
    Quantity of Parts
    Part # Package Quantity Total Product Quantity
    Part 1 6 POUCH 12 
    Part 2 4 POUCH
    Part 1 of 2
    ALKA-SELTZER PLUS  DAY MULTIP-SYMPTOMS NON-DROWSY COLD
    aspirin,dextromethorphan hydrobromide,phenylephrine bitartrate tablet, effervescent
    Product Information
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 325 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg
    PHENYLEPHRINE BITARTRATE (UNII: 27O3Q5ML57) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE BITARTRATE 7.8 mg
    Inactive Ingredients
    Ingredient Name Strength
    ASPARTAME (UNII: Z0H242BBR1)  
    CALCIUM SILICATE (UNII: S4255P4G5M)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DOCUSATE SODIUM (UNII: F05Q2T2JA0)  
    MANNITOL (UNII: 3OWL53L36A)  
    POVIDONES (UNII: FZ989GH94E)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    Product Characteristics
    Color white Score no score
    Shape ROUND Size 25mm
    Flavor CITRUS Imprint Code ASP;DAY
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 2 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part343 01/09/2015
    Part 2 of 2
    ALKA-SELTZER PLUS  NIGHT MULTI-SYMPTOM COLD
    aspirin,dextromethorphan hydrobromide, doxylamine succinate, phenylephrine bitartrate tablet, effervescent
    Product Information
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE 6.25 mg
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 500 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg
    PHENYLEPHRINE BITARTRATE (UNII: 27O3Q5ML57) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE BITARTRATE 7.8 mg
    Inactive Ingredients
    Ingredient Name Strength
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    ASPARTAME (UNII: Z0H242BBR1)  
    CALCIUM SILICATE (UNII: S4255P4G5M)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DOCUSATE SODIUM (UNII: F05Q2T2JA0)  
    MANNITOL (UNII: 3OWL53L36A)  
    POVIDONES (UNII: FZ989GH94E)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    Product Characteristics
    Color white Score no score
    Shape ROUND Size 25mm
    Flavor LEMON Imprint Code ASP;NT
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 2 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part343 01/12/2015
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part341 01/09/2015 11/01/2018
    Labeler - Bayer HealthCare LLC. (112117283)
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