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Alka-Seltzer Plus® Day Non-Drowsy
2015-09-06 05:20:34 来源: 作者: 【 】 浏览:340次 评论:0
  • SPL UNCLASSIFIED SECTION

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

    Drug Facts

  • 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
  • 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
  • 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.

  • 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
  • Other information

     

    • store at room temperature. Avoid excessive heat.
  • 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

  • Questions or comments?

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

  • SPL UNCLASSIFIED SECTION

    Alka-Seltzer Plus® Night
    Cold & Flu Liquid Gels

    Drug Facts

  • 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
  • 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
  • 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.

  • 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
  • Other information

     

    • store at room temperature. Avoid excessive heat.
  • 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

  • Questions or comments?

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

  • SPL UNCLASSIFIED SECTION

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

  • 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
  • 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 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 (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen 325 mg
    Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS) Dextromethorphan Hydrobromide 10 mg
    Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV) Phenylephrine Hydrochloride 5 mg
    Inactive Ingredients
    Ingredient Name Strength
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    gelatin (UNII: 2G86QN327L)  
    glycerin (UNII: PDC6A3C0OX)  
    mannitol (UNII: 3OWL53L36A)  
    polyethylene glycol 400 (UNII: B697894SGQ)  
    povidone K30 (UNII: U725QWY32X)  
    propylene glycol (UNII: 6DC9Q167V3)  
    shellac (UNII: 46N107B71O)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    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 (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen 325 mg
    Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS) Dextromethorphan Hydrobromide 10 mg
    Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV) Phenylephrine Hydrochloride 5 mg
    Doxylamine succinate (UNII: V9BI9B5YI2) (Doxylamine - UNII:95QB77JKPL) Doxylamine succinate 6.25 mg
    Inactive Ingredients
    Ingredient Name Strength
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    gelatin (UNII: 2G86QN327L)  
    glycerin (UNII: PDC6A3C0OX)  
    mannitol (UNII: 3OWL53L36A)  
    polyethylene glycol 400 (UNII: B697894SGQ)  
    povidone K30 (UNII: U725QWY32X)  
    propylene glycol (UNII: 6DC9Q167V3)  
    shellac (UNII: 46N107B71O)  
    sorbitan (UNII: 6O92ICV9RU)  
    sorbitol (UNII: 506T60A25R)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    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 
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