nighttime sinus capsule, liquid filled

nighttime sinus capsule, liquid filled
SPL v3
SPL
SPL Set ID 0f3b1404-9252-470a-aa8c-b360c85731f3
Route
oral
Published
Effective Date 2019-11-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
acetaminophen (325 mg) doxylamine (6.25 mg) phenylephrine (5 mg)
Inactive Ingredients
fd&c blue no. 1 gelatin glycerin polyethylene glycol, unspecified povidone propylene glycol water sorbitol

Identifiers & Packaging

Pill Appearance
Imprint: 665 Shape: capsule Color: blue Size: 21 mm Score: 1
Marketing Status
otc monograph drug active Since 2015-02-26

Purpose

Pain reliever Antihistamine Nasal decongestant

Description

Acetaminophen 325 mg Doxylamine succinate 6.25 mg Phenylephrine HCl 5 mg


Medication Information

Warnings

Liver warning

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

  • more than 4 doses in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks daily while using this product

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

  • skin reddening
  • blisters
  • rash

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

Uses

temporarily relieves nasal and sinus symptoms:

  • sinus pain 
  • headache  
  • nasal and sinus congestion 
  • runny nose and sneezing
Purpose

Pain reliever

Antihistamine

Nasal decongestant

Directions
  • take only as directed - see Overdose warning
  • do not exceed 4 doses per 24 hrs

adults and children 12 years of age and over

 take 2 softgels with water every 4 hrs

Children 4 to under 12 years of age

 ask a doctor

children under 4 years of age

do not use
  • when using other Daytime or Nighttime products, carefully read each label to insure correct dosing
Other Information
  • store at room temperature 15°-30°C (59°-86°F)
Inactive Ingredients

FD&C Blue #1, gelatin, glycerin, polyethylene glycol,  povidone, propylene glycol, purified water, sorbitol special, white edible ink

Manufactured by:

Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.

Wuhan, Hubei

430206, China

Description

Acetaminophen 325 mg Doxylamine succinate 6.25 mg Phenylephrine HCl 5 mg

Section 50565-1

Keep out of reach of children.

Section 53414-9

If pregnant or breast-feeding,ask a health professional before use.

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.   
  • to make a child sleep                                                                                                          
Overdose Warning

Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults and children even if you do not notice any signs or symptoms.

When Using This Product
  • do not use more than directed
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • be careful when driving a motor vehicle or operating machinery
  • alcohol, sedatives & tranquilizers may increase drowsiness
Stop Use and Ask A Doctor If
  • redness or swelling is present 
  • you get nervous, dizzy or sleepless              
  • fever gets worse or lasts more than 3 days
  • new symptoms occur       
  • symptoms do not get better within 7 days or are accompanied by a fever 
Ask A Doctor Before Use If You Have
  • liver disease
  • heart disease
  • thyroid disease
  • diabetes
  • high blood pressure
  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • trouble urinating due to enlarged prostate gland
Active Ingredients (in Each Softgel)

Acetaminophen 325 mg

Doxylamine succinate 6.25 mg

Phenylephrine HCl 5 mg

Principal Display Panel Shipping Label

NightTime Sinus Capsules

Quantity : 4000 Capsules

NDC. No : 53345-031-01

IMPORTANT:

Inspect immediate upon receipt.

This is a bulk shipment, intended for further processing only.

Protect from heat, humidity, and light. Do not refrigerate.

CAUTION : "FOR FURTHER MANUFACTURING, PROCESSING OR REPACKAGING"

Ask A Doctor Or Pharmacist Before Use If You Are
  • taking sedatives or tranquilizers
  • taking the blood thinning drug warfarin

Structured Label Content

Warnings

Liver warning

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

  • more than 4 doses in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks daily while using this product

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

  • skin reddening
  • blisters
  • rash

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

Uses

temporarily relieves nasal and sinus symptoms:

  • sinus pain 
  • headache  
  • nasal and sinus congestion 
  • runny nose and sneezing
Purpose

Pain reliever

Antihistamine

Nasal decongestant

Directions
  • take only as directed - see Overdose warning
  • do not exceed 4 doses per 24 hrs

adults and children 12 years of age and over

 take 2 softgels with water every 4 hrs

Children 4 to under 12 years of age

 ask a doctor

children under 4 years of age

do not use
  • when using other Daytime or Nighttime products, carefully read each label to insure correct dosing
Other Information (Other information)
  • store at room temperature 15°-30°C (59°-86°F)
Inactive Ingredients (Inactive ingredients)

FD&C Blue #1, gelatin, glycerin, polyethylene glycol,  povidone, propylene glycol, purified water, sorbitol special, white edible ink

Manufactured by:

Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.

Wuhan, Hubei

430206, China

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 53414-9 (53414-9)

If pregnant or breast-feeding,ask a health professional before use.

Do Not Use (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.   
  • to make a child sleep                                                                                                          
Overdose Warning (Overdose warning)

Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults and children even if you do not notice any signs or symptoms.

When Using This Product (When using this product)
  • do not use more than directed
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • be careful when driving a motor vehicle or operating machinery
  • alcohol, sedatives & tranquilizers may increase drowsiness
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • redness or swelling is present 
  • you get nervous, dizzy or sleepless              
  • fever gets worse or lasts more than 3 days
  • new symptoms occur       
  • symptoms do not get better within 7 days or are accompanied by a fever 
Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • liver disease
  • heart disease
  • thyroid disease
  • diabetes
  • high blood pressure
  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • trouble urinating due to enlarged prostate gland
Active Ingredients (in Each Softgel) (Active ingredients (in each softgel))

Acetaminophen 325 mg

Doxylamine succinate 6.25 mg

Phenylephrine HCl 5 mg

Principal Display Panel Shipping Label (PRINCIPAL DISPLAY PANEL - Shipping Label)

NightTime Sinus Capsules

Quantity : 4000 Capsules

NDC. No : 53345-031-01

IMPORTANT:

Inspect immediate upon receipt.

This is a bulk shipment, intended for further processing only.

Protect from heat, humidity, and light. Do not refrigerate.

CAUTION : "FOR FURTHER MANUFACTURING, PROCESSING OR REPACKAGING"

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)
  • taking sedatives or tranquilizers
  • taking the blood thinning drug warfarin

Advanced Ingredient Data


Raw Label Data

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