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Day and Night Severe Sinus Congestion and Cough Maximum Strength

Medically reviewed on Feb 8, 2018

Dosage form: kit
Ingredients: ACETAMINOPHEN 325mg, DEXTROMETHORPHAN HYDROBROMIDE 10mg, PHENYLEPHRINE HYDROCHLORIDE 5mg; ACETAMINOPHEN 325mg, DEXTROMETHORPHAN HYDROBROMIDE 10mg, PHENYLEPHRINE HYDROCHLORIDE 5mg, DOXYLAMINE SUCCINATE 6.25mg
Labeler: PuraCap Pharmaceutical LLC
NDC Code: 51013-427

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.

Day and Night Severe Sinus Congestion and Cough

Day Severe Sinus Congestion & Cough
Active ingredients (in each softgel)

Acetaminophen 325 mg 

Dextromethorphan hydrobromide 10 mg
Phenylephrine hydrochloride 5 mg

Night Sever Sinus Congestion  & Cough
Active 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 & Cough
Warnings

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 & Cough
Warnings

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 & Cough
Directions
  • 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 & Cough
Directions
  • 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 & Cough
Other information
  • Store at room temperature 15°-30°C (59°-86°F).

Night Sever Sinus Congestion & Cough
Other information
  • Store at room temperature 15°-30°C (59°-86°F) and avoid excessive heat.

Day Severe Sinus Congestion & Cough
Inactive 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 & Cough
Inactive 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 & Cough
Questions or comments?

Call toll free: 1-855-215-8180

Night Sever Sinus Congestion & Cough
Questions 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

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 Description
1NDC:51013-427-081 KIT in 1 CARTON
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BLISTER PACK 12 
Part 21 BLISTER PACK
Part 1 of 2
DAY SEVERE SINUS CONGESTION AND COUGH 
acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride capsule, liquid filled
Product Information
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE10 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
FD&C RED NO. 40 
FD&C YELLOW NO. 6 
GELATIN 
GLYCERIN 
POLYETHYLENE GLYCOLS 
POVIDONE 
PROPYLENE GLYCOL 
WATER 
SORBITOL 
SORBITAN 
Product Characteristics
Colororange (clear) Scoreno score
Shapecapsule (oblong) Size20mm
FlavorImprint CodePC9
Contains    
Packaging
#Item CodePackage Description
11 BLISTER PACK in 1 CARTON
112 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
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 AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE10 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg
DOXYLAMINE SUCCINATE (DOXYLAMINE) DOXYLAMINE SUCCINATE6.25 mg
Inactive Ingredients
Ingredient NameStrength
D&C YELLOW NO. 10 
FD&C BLUE NO. 1 
GELATIN 
GLYCERIN 
POLYETHYLENE GLYCOLS 
POVIDONE 
PROPYLENE GLYCOL 
WATER 
SORBITOL 
SORBITAN 
Product Characteristics
Colorgreen (clear) Scoreno score
Shapecapsule (oblong) Size21mm
FlavorImprint CodePC22
Contains    
Packaging
#Item CodePackage Description
11 BLISTER PACK in 1 CARTON
18 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
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/FEIOperations
Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd421293287manufacture(51013-427), analysis(51013-427)

 
PuraCap Pharmaceutical LLC

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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