Daytime Sinus Capsules, Liquid Filled

Daytime Sinus Capsules, Liquid Filled
SPL v3
SPL
SPL Set ID a0b01aef-4248-4d41-862c-0c8884dfca5e
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) Phenylephrine (5 mg)
Inactive Ingredients
Fd&c Yellow No. 6 Gelatin Glycerin Polyethylene Glycol, Unspecified Povidone Propylene Glycol Water Sorbitol

Identifiers & Packaging

Pill Appearance
Imprint: 663 Shape: capsule Color: orange Size: 21 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2015-02-26

Description

Acetaminophen 325 mg Phenylephrine HCl 5 mg

Purpose

Pain reliever Nasal decongestant


Medication Information

Purpose

Pain reliever

Nasal decongestant

Description

Acetaminophen 325 mg Phenylephrine HCl 5 mg

Uses

temporarily relieves sinus symptoms:

  • sinus pain
  • headache
  • nasal and sinus congestion
Section 50565-1

Keep out of reach of children.

Section 50567-7

When using this product, do not use more than directed.

Section 50568-5

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.   

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 for this product
  • 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 hours

adults and children 12 years of age and over

 take 2 softgels with water every 4 hours

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.                                                                                                             
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. Prompt medical attention is critical for adults as well as 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 Yellow #6, gelatin, glycerin, polyethylene glycol,  povidone, propylene glycol, purified water, sorbitol special and white edible ink

Manufactured by:

Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.

Wuhan, Hubei

430206, China

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   
  • trouble urinating due to enlarged prostate gland
Active Ingredients (in Each Capsule)

Acetaminophen 325 mg

Phenylephrine HCl 5 mg

Principal Display Panel Shipping Label

DayTime Sinus Capsules

Quantity : 4000 Capsules

NDC. No : 53345-030-01

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 REPACKING"


Structured Label Content

Uses

temporarily relieves sinus symptoms:

  • sinus pain
  • headache
  • nasal and sinus congestion
Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50567-7 (50567-7)

When using this product, do not use more than directed.

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.   

Section 53414-9 (53414-9)

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

Purpose

Pain reliever

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 for this product
  • 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 hours

adults and children 12 years of age and over

 take 2 softgels with water every 4 hours

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.                                                                                                             
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. Prompt medical attention is critical for adults as well as 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 Yellow #6, gelatin, glycerin, polyethylene glycol,  povidone, propylene glycol, purified water, sorbitol special and white edible ink

Manufactured by:

Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.

Wuhan, Hubei

430206, China

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   
  • trouble urinating due to enlarged prostate gland
Active Ingredients (in Each Capsule) (Active ingredients (in each capsule))

Acetaminophen 325 mg

Phenylephrine HCl 5 mg

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

DayTime Sinus Capsules

Quantity : 4000 Capsules

NDC. No : 53345-030-01

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 REPACKING"


Advanced Ingredient Data


Raw Label Data

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