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

  • 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 September 10, 2018

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • ACTIVE INGREDIENT

    Active ingredients (in each tablet)

    Aspirin 500 mg (NSAID)*

    Dextromethorphan hydrobromide 10 mg

    Doxylamine succinate 6.25 mg

    Phenylephrine bitartrate 7.8 mg

    *nonsteroidal anti-inflammatory drug

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  • PURPOSE

    Purposes

    Pain reliever/fever reducer

    Cough suppressant

    Antihistamine

    Nasal decongestant

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  • Uses

    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

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  • WARNINGS

    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.

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  • DO NOT USE

    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

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  • ASK DOCTOR

    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 ● 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

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  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are

    ● taking a prescription drug for

    ● gout ● diabetes ● arthritis

    ● taking sedatives or tranquilizers

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  • 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

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  • 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 a 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

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  • 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.

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  • 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

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  • Directions

    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

    Other information

    ● each tablet contains: sodium 476 mg

    ● Phenylketonurics: Contains Phenylalanine 5.6 mg Per Tablet

    ● store at room temperature. Avoid excessive heat.

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  • INACTIVE INGREDIENT

    Inactive ingredients acesulfame potassium, anhydrous citric

    acid, aspartame, calcium silicate, dimethicone, docusate sodium,

    flavors (natural & artificial), mannitol, povidone, sodium benzoate,

    sodium bicarbonate

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  • Questions or comments?

    Questions or comments?1-800-986-0369 (Mon-Fri 9AM -

    5PM EST)

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  • PRINCIPAL DISPLAY PANEL

    Alka-Seltzer

    Plus ®

    Cold

    Night

    Lemon

    ASPIRIN ( NSAID) / Pain Reliever-Fever Reducer

    Dextromethorphan HBr / Cough Suppressant

    Doxylamine Succinate / Antihistamine

    Phenylephrine Bitartrate / Nasal Decongestant

    • Nasal Congestion
    • Headache & Body Ache
    • Cough
    • Runny Nose
    • Sore Throat

    20 EFFERVESCENT TABLETS

    Carton 20 count

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  • INGREDIENTS AND APPEARANCE
    ALKA-SELTZER PLUS COLD NIGHT 
    aspirin, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine bitartrate tablet, effervescent
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0280-1545
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 500 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg
    DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE 6.25 mg
    PHENYLEPHRINE BITARTRATE (UNII: 27O3Q5ML57) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE BITARTRATE 7.8 mg
    Inactive Ingredients
    Ingredient Name Strength
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DOCUSATE SODIUM (UNII: F05Q2T2JA0)  
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    ASPARTAME (UNII: Z0H242BBR1)  
    CALCIUM SILICATE (UNII: S4255P4G5M)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    POVIDONE (UNII: FZ989GH94E)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    MANNITOL (UNII: 3OWL53L36A)  
    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 NDC:0280-1545-20 10 in 1 CARTON 09/14/2018
    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 final part341 09/14/2018
    Labeler - Bayer HealthCare LLC. (112117283)
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