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  5. Label Information: Green Guard Advanced Sinus Relief

FDA Label for Green Guard Advanced Sinus Relief

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS (IN EACH TABLET)
    2. PURPOSES
    3. USES
    4. OTHER
    5. ALLERGY ALERT:
    6. DO NOT USE
    7. ASK A DOCTOR BEFORE USE IF YOU HAVE
    8. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
    9. STOP USE AND ASK A DOCTOR IF
    10. OTC - PREGNANCY OR BREAST FEEDING
    11. KEEP OUT OF REACH OF CHILDREN.
    12. DIRECTIONS
    13. OTHER INFORMATION
    14. INACTIVE INGREDIENTS
    15. OTC - QUESTIONS
    16. 819R GG ADVANCED SINUS RELIEF PRINCIPAL DISPLAY PANEL

Green Guard Advanced Sinus Relief Product Label

The following document was submitted to the FDA by the labeler of this product Unifirst First Aid Corporation. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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.