NDC 0363-0555 Sinus Relief Daytime Nighttime

NDC Product Code 0363-0555

NDC 0363-0555-22

Package Description: 1 KIT in 1 PACKAGE, COMBINATION * 8 CAPSULE in 1 BLISTER PACK * 8 CAPSULE in 1 BLISTER PACK

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Sinus Relief Daytime Nighttime with NDC 0363-0555 is a product labeled by Walgreen Co.. The generic name of Sinus Relief Daytime Nighttime is . The product's dosage form is and is administered via form.

Labeler Name: Walgreen Co.

Dosage Form: -

Product Type: What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
  • POLYVINYL ALCOHOL (UNII: 532B59J990)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
  • POLYVINYL ALCOHOL (UNII: 532B59J990)
  • STARCH, CORN (UNII: O8232NY3SJ)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Walgreen Co.
Labeler Code: 0363
Start Marketing Date: 07-21-2005 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2019 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: I What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Information for Patients

Acetaminophen

Acetaminophen is pronounced as (a set a mee' noe fen)

Why is acetaminophen medication prescribed?
Acetaminophen is used to relieve mild to moderate pain from headaches, muscle aches, menstrual periods, colds and sore throats, toothaches, backaches, and reactions to va...
[Read More]
Doxylamine

Doxylamine is pronounced as (dox il' a meen)
Why is doxylamine medication prescribed?
Doxylamine is used in the short-term treatment of insomnia (difficulty falling asleep or staying asleep). Doxylamine is also used in combination with decongestants and ot...
[Read More]
Phenylephrine

Phenylephrine is pronounced as (fen il ef' rin)
Why is phenylephrine medication prescribed?
Phenylephrine is used to relieve nasal discomfort caused by colds, allergies, and hay fever. It is also used to relieve sinus congestion and pressure. Phenylephrine will ...
[Read More]

* Please review the disclaimer below.

Sinus Relief Daytime Nighttime Product Label Images

Sinus Relief Daytime Nighttime Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredients (In Each Liquid Cap)

Acetaminophen 325 mgPhenyelphrine HCl 5 mg

Purpose

Pain relieverNasal decongestnat

Pain relieverAntihistamineNasal decongestant

Uses

  • Temporarily relieves nasal and sinus symptoms:sinus painheadachenasal and sinus congestion

  • Temporarily relieves nasal and sinus symptoms:
  • Headachesinus painnasal and sinus congestionrunny nose and sneezing

Warnings

  • Liver warning: This product contains acetaminophen.  Severe liver damage may occur if you take:more than 12 liquid caps in 24 hours, which is the maximum daily amountwith other drugs containing acetaminohen3 or more alcoholic drinks every ay while using this product

  • Liver warning: This product contains acetaminophen.  Severe liver damage may occur if you take:more than 12 liquid caps in 24 hours, which is the maximum daily amountwith other drugs containing acetaminohen3 or more alcoholic drinks every ay while using this product

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.

  • 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.

Ask A Doctor Before Use If You Have

  • Liver diseaseheart diseasehigh blood pressurethyroid diseasediabetestrouble urinating due to an enlarged prostate gland

  • Liver diseaseheart diseasehigh blood pressureglaucomathyroid diseasediabetestrouble urinating due to an enlarged prostate glanda breathing problem such as emphysema or chronic bronchitis

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

  • Do not exceed recommended dosageexcitability may occur, expecially in childrenmarked drowsiness may occuralcohol, sedatives, and tranquilizers may increase drowsinessavoid alcoholic drinksbe careful when driving a motor vehicle or operating machinery

Stop Use And Ask A Doctor If

  • Redness or swellling is presentnervousness, dizziness, or sleeplessness occurpain or nasal congestion gets worse or lasts more than 7 daysfever gets worse or lasts more than 3 daysnew symptoms occurThese could be signs of a serious condition.

  • Redness or swellling is presentnervousness, dizziness, or sleeplessness occurpain or nasal congestion gets worse or lasts more than 7 daysfever gets worse or lasts more than 3 daysnew symptoms occurThese could be signs of a serious condition.

If Pregnant Or Breast-Feeding,

Ask a health professional before use.

Ask a health professional before use.

Keep Out Of Reach Of Children.

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage.  In case of overdose, get medical help or contact a Poison Control Center right away.  Quickmedical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage.  In case of overdose, get medical help or contact a Poison Control Center right away.  Quickmedical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

  • Take only as recommended (see overdose warning)adults and children 12 years and over2 liquid caps with water every 4 hoursdo not take more than 12 liquid caps in 24 hourschildren under 12 years: do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage

  • Take only as recommended (see overdose warning)adults and children 12 years and over
  • 2 liquid caps with water every 4 hoursdo not take more than 12 liquid caps in 24 hourschildren under 12 years: do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage

Other Information

  • Store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)see end flap for expiration date and lot numberfor better identification, keep liquid caps in carton until used

  • Store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)see end flap for expiration date and lot numberfor better identification, keep liquid caps in carton until used

Inactive Ingredients

Edible white ink, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol

Edible white ink, FD&C blue #1, gelatin, glyercin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol

Active Ingredient (In Each Liquid Cap)

Acetaminophen 325 mgDoxylamine succinate 6.25 mgPhenylephrine HCl 5 mg

Ask A Doctor Or Pharmacist Before Use If You Are

  • Taking the blood thinning drug warfarintaking sedatives or tranquilizers

* Please review the disclaimer below.