Green Guard Advanced Sinus Relief description, usages, side effects, indications, overdosage, supplying and lots more!

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Green Guard Advanced Sinus Relief

Unifirst First Aid Corporation

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert

819R GG Advanced Sinus Relief


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

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

Warnings

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 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

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

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

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 to children under 12 years of age.

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

*may contain

Questions or comments? 1-800-869-6970

819R GG Advanced Sinus Relief Label

Advanced Sinus relief™
Pull to Open
Acetaminophen 500mg/Acetaminofeno 500mg
Phenylephrine HCl 5mg/Fenilefrina HCl 5mg
See new warnings information
GREEN GUARD®
Tabletas mejoradas
Para el alivio sinusal
50 Packets of 2 Tablets
100 Tablets
Order #2206
Distributed by Green Guard®, St Louis, MO 63045

Green Guard Advanced Sinus Relief

ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:47682-002
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 500 mg
Phenylephrine Hydrochloride PHENYLEPHRINE 5 mg

Inactive Ingredients

Ingredient Name Strength
cellulose, microcrystalline
FD&C BLUE NO. 1
povidone
STEARIC ACID
SODIUM STARCH GLYCOLATE TYPE A POTATO
STARCH, CORN

Product Characteristics

Color Size Imprint Code Shape
blue (blue) 12 mm FR33 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:47682-002-99 2 in 1 PACKET
2 NDC:47682-002-99 2 in 1 PACKET
3 NDC:47682-002-48 125 in 1 BOX, UNIT-DOSE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2008-12-30


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