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

Description

Acetaminophen 325 mg Doxylamine succinate 6.25 mg Phenylephrine HCl 5 mg

Purpose

Pain reliever Antihistamine Nasal decongestant


Medication Information

Purpose

Pain reliever

Antihistamine

Nasal decongestant

Description

Acetaminophen 325 mg Doxylamine succinate 6.25 mg Phenylephrine HCl 5 mg

Uses

temporarily relieves nasal and sinus symptoms:

  • sinus pain 
  • headache  
  • nasal and sinus congestion 
  • runny nose and sneezing
Section 50565-1

Keep out of reach of children.

Section 53414-9

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

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.

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
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.

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

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

Uses

temporarily relieves nasal and sinus symptoms:

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

Purpose

Pain reliever

Antihistamine

Nasal decongestant

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.

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
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.

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

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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