Label: ALKA-SELTZER PLUS  NIGHT COLD MEDICINE- aspirin, doxylamine succinate, phenylephrine bitartrate and dextromethorphan hydrobromide tablet, effervescent 

  • Label RSS
  • NDC Code(s): 0280-1430-32
  • Packager: Bayer HealthCare LLC, Consumer Care
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 07/10

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • ACTIVE INGREDIENT

    Active ingredients (in each tablet) Purposes
    Aspirin 500 mg Pain reliever/fever reducer
    Dextromethorphan HBr 10 mg Cough suppressant
    Doxylamine succinate 6.25 mg Antihistamine
    Phenylephrine bitartrate 7.8 mg Nasal decongestant
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  • Uses

    • temporarily relieves these symptoms due to a cold:
      • minor aches and pains
      • sinus congestion and pressure
      • sore throat
      • headache
      • cough
      • nasal congestion
      • runny nose
      • sneezing
    • temporarily reduces fever
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  • Warnings

    Reye's syndrome

    Children and teenagers should not use this medicine for chicken pox or flu symptoms before a doctor is consulted about Reye's syndrome, a rare but serious illness reported to be associated with aspirin.

    Allergy alert

    Aspirin may cause a severe allergic reaction which may include:

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

    Alcohol warning

    If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take aspirin or other pain relievers/fever reducers. Aspirin may cause stomach bleeding.

    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.
    • in children under 12 years of age

    Ask a doctor before use if you have

    • stomach problems (such as heartburn, upset stomach, or stomach pain) that last or come back
    • bleeding problems
    • ulcers
    • asthma
    • heart disease
    • high blood pressure
    • 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

    Ask a doctor or pharmacist before use if you are

    • taking a prescription drug for
      • anticoagulation (blood thinning)
      • diabetes
      • gout
      • 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 operating machinery
    • excitability may occur, especially in children

    Stop use and ask a doctor if

    • an allergic reaction occurs. Seek medical help right away.
    • 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

    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.

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

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  • 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
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  • Other information

    • each tablet contains: sodium 474 mg
    • Phenylketonurics: Contains Phenylalanine 5.6 mg per tablet
    • store at room temperature. Avoid excessive heat.
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  • Inactive ingredients

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

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  • Questions or comments?

    1-800-986-0369 (Mon – Fri 9AM – 5PM EST) or www.alkaseltzerplus.com

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  • PRINCIPAL DISPLAY PANEL - Shipper Label

    ALKA-SELTZER PLUS®
    NIGHT COLD FORMULA

    3200 TABLETS 1600 PIECES

    SHIPPER
    CODE
    1 00 16500 54213 8

    MADE IN
    MEXICO

    PRODUCT CODE

    82411594

    STORE AT ROOM
    TEMPERATURE.
    AVOID EXCESSIVE HEAT

    Bayer HealthCare LLC
    Consumer Care
    P.O. Box 1910, Morristown, NJ
    07962-1910 USA

    Principal Display Panel – Shipper Label
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  • INGREDIENTS AND APPEARANCE
    ALKA-SELTZER PLUS   NIGHT COLD MEDICINE
    aspirin, doxylamine succinate, phenylephrine bitartrate, and dextromethorphan hydrobromide tablet, effervescent
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0280-1430
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Aspirin (Aspirin) Aspirin 500 mg
    Doxylamine succinate (Doxylamine) Doxylamine succinate 6.25 mg
    Phenylephrine bitartrate (Phenylephrine) Phenylephrine bitartrate 7.8 mg
    Dextromethorphan hydrobromide (Dextromethorphan) Dextromethorphan hydrobromide 10 mg
    Product Characteristics
    Color WHITE Score no score
    Shape ROUND Size 26mm
    Flavor LEMON Imprint Code A;S;NT
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0280-1430-32 1600 in 1 CASE
    1 2 in 1 POUCH
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part341 08/01/2010
    Labeler - Bayer HealthCare LLC, Consumer Care (785159372)
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