Green Guard Advanced Sinus Relief Tablet
FDA Label NDC 47682-001

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Unifirst First Aid Corporation for the product Green Guard Advanced Sinus Relief (NDC 47682-001). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients (in each tablet), purposes, uses, other, allergy alert:, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients (In Each Tablet)

Acetaminophen     500mg

Phenylephrine HCl     5mg

Purposes

Pain reliever

Nasal decongestant

Uses

Temporarily relieves nasal congestion due to

  • ■ common cold
  • ■ hay fever or other respiratory allergies

    • Temporarily

    • ■ promotes nasal and/or sinus drainage; relieves sinus congestion and pressure
    • ■ reduces fever

      • Temporarily 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.

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 59°-86°F (15°-30°C)
  • ■ 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

819R Gg Advanced Sinus Relief Principal Display Panel

Advanced Sinus relief™

Tabletas mejoradas
para el alivio sinusal

GREEN GUARD ®

Pull to Open

Tire Para Abrir

Acetaminophen 500mg/Acetaminofeno 500mg
Phenylephrine HCl 5mg/Fenilefrina HCl 5mg

125 Packets of 2 Tablets
250 Tablets
Order #2207

Distributed by Green Guard ®, St Louis, MO 63045

* Please review the disclaimer below.