Label: ALKA-SELTZER PLUS  DAY AND NIGHT MULTI-SYMPTOM COLD AND FLU FORMULA- acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride and doxylamine succinate   

  • Label RSS
  • NDC Code(s): 0280-1146-20
  • Packager: Bayer HealthCare LLC, Consumer Care
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 05/12

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

  • SPL UNCLASSIFIED SECTION

    Alka-Seltzer Plus® Day Non-Drowsy
    Cold & Flu Liquid Gels

    Drug Facts

    Close
  • ACTIVE INGREDIENT

    Active ingredients (in each capsule) Purposes
    Acetaminophen 325 mg Pain reliever/fever reducer
    Dextromethorphan hydrobromide 10 mg Cough suppressant
    Phenylephrine hydrochloride 5 mg Nasal decongestant
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  • Uses

    • temporarily relieves these symptoms due to a cold or flu:
      • minor aches and pains
      • headache
      • cough
      • sore throat
      • nasal and sinus congestion
    • temporarily reduces fever
    Close
  • Warnings

    Liver warning

    This product contains acetaminophen. Severe liver damage may occur if you take

    • more than 10 capsules in 24 hours, which is the maximum daily amount for this product
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks every day while using this product

    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

    • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
    • 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

    • liver disease
    • heart disease
    • high blood pressure
    • 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

    Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

    When using this product do not exceed recommended dosage

    Stop use and ask a doctor if

    • 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
    • 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.

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

    Close
  • Directions

    • do not take more than the recommended dose
    • adults and children 12 years and over: take 2 capsules with water every 4 hours. Do not exceed 10 capsules in 24 hours or as directed by a doctor
    • children under 12 years: do not use
    Close
  • Other information

    • store at room temperature. Avoid excessive heat.
    Close
  • Inactive ingredients

    FD&C red #40, FD&C yellow #6, gelatin, glycerin, mannitol, polyethylene glycol 400, povidone, propylene glycol, purified water, shellac, simethicone, sorbitol sorbitan solution, titanium dioxide

    Close
  • Questions or comments?

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

    Close
  • SPL UNCLASSIFIED SECTION

     

    Alka-Seltzer Plus® Night
    Cold & Flu Liquid Gels

    Drug Facts

    Close
  • ACTIVE INGREDIENT

    Active ingredients (in each capsule) Purposes
    Acetaminophen 325 mg Pain reliever/fever reducer
    Dextromethorphan hydrobromide 10 mg Cough suppressant
    Doxylamine succinate 6.25 mg Antihistamine
    Phenylephrine hydrochloride 5 mg Nasal decongestant
    Close
  • Uses

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

    Liver warning

    This product contains acetaminophen. Severe liver damage may occur if you take

    • more than 10 capsules in 24 hours, which is the maximum daily amount for this product
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks every day while using this product

    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

    • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
    • 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

    • liver disease
    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • 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

    Ask a doctor or pharmacist before use if you are

    • taking the blood thinning drug warfarin
    • 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

    • 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
    • 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.

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

    Close
  • Directions

    • do not take more than the recommended dose
    • adults and children 12 years and over: take 2 capsules with water every 4 hours. Do not exceed 10 capsules in 24 hours or as directed by a doctor.
    • children under 12 years: do not use
    Close
  • Other information

    • store at room temperature. Avoid excessive heat.
    Close
  • Inactive ingredients

    D&C yellow #10, FD&C blue #1, gelatin, glycerin, mannitol, polyethylene glycol 400, povidone, propylene glycol, purified water, shellac, simethicone, sorbitan, sorbitol, titanium dioxide

    Close
  • Questions or comments?

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

    Close
  • SPL UNCLASSIFIED SECTION

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

    Close
  • PRINCIPAL DISPLAY PANEL - Capsule Kit Carton

    NEW DIRECTIONS
    NEW LOOK

    Alka-
    Seltzer
    PLUS
    ®

    NON DROWSY DAY

    MULTI -SYMPTOM COLD & FLU FORMULA

    Acetaminophen / Pain reliever-fever reducer
    Dextromethorphan hydrobromide / Cough suppressant
    Phenylephrine HCI / Nasal decongestant

    Nasal Congestion
    Headache &
    Body Ache•Cough
    Sore Throat
    Sinus Pressure

    12 LIQUID GELS
    (Liquid Filled Capsules)

    NIGHT

    Acetaminophen / Pain reliever-fever reducer
    Dextromethorphan hydrobromide / Cough suppressant
    Doxylamine succinate / Antihistamine
    Phenylephrine HCI / Nasal decongestant

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

    8 LIQUID GELS
    (Liquid Filled Capsules)

    Principal Display Panel - Capsule Kit Carton
    Close
  • INGREDIENTS AND APPEARANCE
    ALKA-SELTZER PLUS  DAY AND NIGHT MULTI-SYMPTOM COLD AND FLU FORMULA
    acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride and doxylamine succinate kit
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0280-1146
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0280-1146-20 1 in 1 CARTON
    Quantity of Parts
    Part # Package Quantity Total Product Quantity
    Part 1 1 BLISTER PACK 12 
    Part 2 1 BLISTER PACK
    Part 1 of 2
    ALKA-SELTZER PLUS  DAY MULTI-SYMPTOM COLD AND FLU FORMULA
    acetaminophen, dextromethorphan hydrobromide and phenylephrine hydrochloride capsule, liquid filled
    Product Information
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Acetaminophen (Acetaminophen) Acetaminophen 325 mg
    Dextromethorphan Hydrobromide (Dextromethorphan) Dextromethorphan Hydrobromide 10 mg
    Phenylephrine Hydrochloride (Phenylephrine) Phenylephrine Hydrochloride 5 mg
    Inactive Ingredients
    Ingredient Name Strength
    FD&C RED NO. 40  
    D&C YELLOW NO. 10  
    gelatin  
    glycerin  
    mannitol  
    polyethylene glycol 400  
    povidone K30  
    propylene glycol  
    shellac  
    titanium dioxide  
    Product Characteristics
    Color ORANGE Score no score
    Shape OVAL Size 25mm
    Flavor Imprint Code AS;DC
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 12 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part343 05/30/2012
    Part 2 of 2
    ALKA-SELTZER PLUS  NIGHT MULTI-SYMPTOM COLD AND FLU FORMULA
    acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride and doxylamine succinate capsule, liquid filled
    Product Information
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Acetaminophen (Acetaminophen) Acetaminophen 325 mg
    Dextromethorphan Hydrobromide (Dextromethorphan) Dextromethorphan Hydrobromide 10 mg
    Phenylephrine Hydrochloride (Phenylephrine) Phenylephrine Hydrochloride 5 mg
    Doxylamine succinate (Doxylamine) Doxylamine succinate 6.25 mg
    Inactive Ingredients
    Ingredient Name Strength
    D&C YELLOW NO. 10  
    FD&C BLUE NO. 1  
    gelatin  
    glycerin  
    mannitol  
    polyethylene glycol 400  
    povidone K30  
    propylene glycol  
    shellac  
    sorbitan  
    sorbitol  
    titanium dioxide  
    Product Characteristics
    Color GREEN Score no score
    Shape OVAL Size 25mm
    Flavor Imprint Code AS;NITE
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 8 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part343 05/30/2012
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part343 05/30/2012
    Labeler - Bayer HealthCare LLC, Consumer Care (785159372)
    Close