DAY AND NIGHT SEVERE SINUS CONGESTION AND COUGH MAXIMUM STRENGTH (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE) KIT [PURACAP PHARMACEUTICAL

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  • DAY AND NIGHT SEVERE SINUS CONGESTION AND COUGH MAXIMUM STRENGTH (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE) KIT [PURACAP PHARMACEUTICAL

DAY AND NIGHT SEVERE SINUS CONGESTION AND COUGH MAXIMUM STRENGTH (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE) KIT [PURACAP PHARMACEUTICAL
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NDC 51013-427-08
Set ID 85b12eb6-0cf5-461a-a31b-daab85392dd3
Category HUMAN OTC DRUG LABEL
Packager PuraCap Pharmaceutical LLC
Generic Name
Product Class alpha-1 Adrenergic Agonist, Antihistamine
Product Number
Application Number PART341
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  • Day Severe Sinus Congestion & CoughActive ingredients (in each softgel)

    Acetaminophen 325 mg 

    Dextromethorphan hydrobromide 10 mg
    Phenylephrine hydrochloride 5 mg

  • Night Sever Sinus Congestion  & CoughActive ingredients (in each softgel)

    Acetaminophen 325 mg
    Dextromethorphan hydrobromide 10 mg
    Doxylamine succinate 6.25 mg
    Phenylephrine hydrochloride 5 mg

  • Purposes

    Day Severe Sinus Congestion & Cough

    Pain reliever/fever reducer

    Cough suppressant

    Nasal decongestant

  • Purposes

    Night Sever Sinus Congestion & Cough

    Pain reliever/fever reducer

    Cough suppressant

    Antihistamine

    Nasal decongestant

  • Uses

    Day Severe Sinus Congestion & Cough

    • temporarily relieves these symptoms due to a cold or flu:
      • nasal congestion
      • sinus congestion and pressure
      • headache
      • minor aches and pains
      • cough
      • sore throat
    • helps clear nasal passages and shrinks swollen membranes
    • temporarily reduces fever
  • Uses

    Night Sever Sinus Congestion & Cough

    • temporarily relieves these symptoms due to a cold or flu:
      • nasal congestion
      • sinus congestion and pressure
      • headache
      • minor aches and pains
      • cough
      • sore throat
      • runny nose
      • sneesing
    • helps clear nasal passages and shrinks swollen membranes
    • temporarily reduces fever
  • Day Severe Sinus Congestion & CoughWarnings

    Liver warning

    These products contain acetaminophen. Severe liver damage may occur if you take

    • more than 10 softgels 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

    Allergy alert: Acetaminophen may cause severe skin or severe allergic reactions. Symptoms may include:

    • skin reddening
    • blisters
    • rash
    • hives
    • facial swelling
    • asthma (wheezing)
    • shock

      If a skin or general allergic reaction occurs, stop use and seek medical help right away.

    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.
    • if you have ever had an allergic reaction to this product or any of its ingredients
    • 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.

  • Night Sever Sinus Congestion & CoughWarnings

    Liver warning

    These products contain acetaminophen. Severe liver damage may occur if you take

    • more than 10 softgels 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

    Allergy alert: Acetaminophen may cause severe skin or severe allergic reactions. Symptoms may include:

    • skin reddening
    • blisters
    • rash
    • hives
    • facial swelling
    • asthma (wheezing)
    • shock

      If a skin or general allergic reaction occurs, stop use and seek medical help right away.

    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.
    • if you have ever had an allergic reaction to this product or any of its ingredients
    • 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.

  • Day Severe Sinus Congestion & CoughDirections

    • do not take more than the recommended dose
    • adults and children 12 years and over: take 2 softgels with water every 4 hours. Do not exceed 10 softgels in 24 hours or as directed by a doctor.
    • children under 12 years: do not use
  • Night Sever Sinus Congestion & CoughDirections

    • do not take more than the recommended dose
    • adults and children 12 years and over: take 2 softgels with water every 4 hours. Do not exceed 10 softgels in 24 hours or as directed by a doctor.
    • children under 12 years: do not use
  • Day Severe Sinus Congestion & CoughOther information

    • Store at room temperature 15°-30°C (59°-86°F).
  • Night Sever Sinus Congestion & CoughOther information

    • Store at room temperature 15°-30°C (59°-86°F) and avoid excessive heat.
  • Day Severe Sinus Congestion & CoughInactive ingredients

    FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, and white ink

  • Night Sever Sinus Congestion & CoughInactive ingredients

    D&C yellow #10, FD&C blue #1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, and white ink

  • Day Severe Sinus Congestion & CoughQuestions or comments?

    Call toll free: 1-855-215-8180

  • Night Sever Sinus Congestion & CoughQuestions or comments?

    Call toll free: 1-855-215-8180

  • PRINCIPAL DISPLAY PANEL

    Day and Night Severe Sinus Congestion and Cough 20ct

    NDC 51013-427-08

    *Compare to the active ingredients in Alka-Seltzer Plus® Maximum Strength Severe Sinus Congestion & Cough Day & Night Liquid Gels

    Carton Front

    Carton Back

  • INGREDIENTS AND APPEARANCE
    DAY AND NIGHT SEVERE SINUS CONGESTION AND COUGH  MAXIMUM STRENGTH
    acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51013-427
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51013-427-081 in 1 CARTON; Type 0: Not a Combination Product02/08/2018
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BLISTER PACK 12 
    Part 21 BLISTER PACK 8 
    Part 1 of 2
    DAY SEVERE SINUS CONGESTION AND COUGH 
    acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride capsule, liquid filled
    Product Information
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    SORBITAN (UNII: 6O92ICV9RU)  
    Product Characteristics
    Colororange (clear) Scoreno score
    Shapecapsule (oblong) Size20mm
    FlavorImprint Code PC9
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    11 in 1 CARTON
    112 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34102/08/2018
    Part 2 of 2
    NIGHT SEVERE SINUS CONGESTION AND COUGH 
    acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride capsule, liquid filled
    Product Information
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE6.25 mg
    Inactive Ingredients
    Ingredient NameStrength
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    SORBITAN (UNII: 6O92ICV9RU)  
    Product Characteristics
    Colorgreen (clear) Scoreno score
    Shapecapsule (oblong) Size21mm
    FlavorImprint Code PC22
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    11 in 1 CARTON
    18 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34102/08/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34102/08/2018
    Labeler - PuraCap Pharmaceutical LLC (962106329)
    Establishment
    NameAddressID/FEIBusiness Operations
    Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd421293287manufacture(51013-427) , analysis(51013-427)
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