NDC 47682-001 Green Guard Advanced Sinus Relief

Acetaminophen, Phenylephrine Hydrochloride

NDC Product Code 47682-001

NDC Code: 47682-001

Proprietary Name: Green Guard Advanced Sinus Relief What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Acetaminophen, Phenylephrine Hydrochloride What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Product Characteristics

Color(s):
WHITE (C48325 - WHITE)
Shape: ROUND (C48348)
Size(s):
12 MM
Imprint(s):
AZ;261
Score: 1

NDC Code Structure

NDC 47682-001-33

Package Description: 50 PACKET in 1 BOX > 2 TABLET in 1 PACKET

NDC 47682-001-48

Package Description: 125 PACKET in 1 BOX > 2 TABLET in 1 PACKET (47682-001-99)

NDC 47682-001-99

Package Description: 2 TABLET in 1 PACKET

NDC Product Information

Green Guard Advanced Sinus Relief with NDC 47682-001 is a a human over the counter drug product labeled by Unifirst First Aid Corporation. The generic name of Green Guard Advanced Sinus Relief is acetaminophen, phenylephrine hydrochloride. The product's dosage form is tablet and is administered via oral form.

Labeler Name: Unifirst First Aid Corporation

Dosage Form: Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.

Product Type: Human Otc Drug 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.

Green Guard Advanced Sinus Relief Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • ACETAMINOPHEN 500 mg/1
  • PHENYLEPHRINE HYDROCHLORIDE 5 mg/1

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.

  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • HYPROMELLOSES (UNII: 3NXW29V3WO)
  • POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • CROSPOVIDONE (UNII: 68401960MK)
  • POVIDONE (UNII: FZ989GH94E)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Product Labeler Information

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

Labeler Name: Unifirst First Aid Corporation
Labeler Code: 47682
FDA Application Number: part341 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 12-30-2008 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: 12-31-2020 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: N 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]
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.

Green Guard Advanced Sinus Relief Product Label Images

Green Guard Advanced Sinus Relief 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 Tablet)

Acetaminophen     500mg
Phenylephrine HCl     5mg

Purposes

Pain relieverNasal decongestant

Uses

  • Temporarily relieves nasal congestion due to■ common cold■ hay fever or other respiratory allergiesTemporarily ■ promotes nasal and/or sinus drainage; relieves sinus congestion and pressure■ reduces feverTemporarily relieves minor aches and pains associated with■ headache■ muscular aches■ minor arthritis pain■ common cold■ toothache■ menstrual cramps

Other

  • Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
  • ■ more than 8 tablets in 24 hours, which is the maximum daily amount
  • ■ with other drugs containing acetaminophen
  • ■ 3 or more alcoholic drinks every day while using this product

Do not exceed recommended dosage. If nervousness, dizziness or sleeplessness occurs, discontinue use and consult a doctor.

Adults and children: (12 years and older) Take 2 tablets every 4 to 6 hours. Do not take more than 8 tablets in 24 hours.

Children under 12 years: Do not give this adult strength product to children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage.

Allergy Alert:

Acetaminophen may cause severe skin reactions. Symptoms may include:■ skin reddening■ blisters■ rashIf a skin reaction occurs, stop use and seek medical help right away.

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.■ for more than 10 days for pain unless directed by a doctor■ for more than 3 days for fever unless directed by a doctor■ 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 disease■ thyroid disease■ diabetes■ high blood pressure■ heart disease■ difficulty in urination due to enlargement of the prostate gland

Ask A Doctor Or Pharmacist Before Use If You Are

  • ■ taking the blood thinning drug warfarin

Stop Use And Ask A Doctor If

  • ■ symptoms do not improve within 7 days or are accompanied by a fever■ pain or fever persists or gets worse■ redness or swelling is present■ any new symptoms appear

Otc - Pregnancy Or Breast Feeding

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. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions





do not use more than directed

Other Information

  • ■ store at room temperature 59º-86ºF (15º-30ºC)■ tamper evident sealed packets■ do not use any opened or torn packets■ avoid excessive heat and humidity

Inactive Ingredients

Corn starch, crospovidone*, FD&C blue #1*, hypromellose*, microcrystalline cellulose, polyethylene glycol*, povidone, sodium starch glycolate*, stearic acid.*may contain

Otc - Questions

Questions or comments? 1-800-869-6970

* Please review the disclaimer below.