GREEN GUARD ADVANCED SINUS RELIEF (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET [UNIFIRST FIRST AID CORPORATION]

GREEN GUARD ADVANCED SINUS RELIEF (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET [UNIFIRST FIRST AID CORPORATION]
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NDC 47682-001-33, 47682-001-48, 47682-001-99
Set ID e8e5fb21-a7fd-44d1-b9c4-83e949699ca6
Category HUMAN OTC DRUG LABEL
Packager Unifirst First Aid Corporation
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each tablet)

    Acetaminophen 500 mg

    Phenylephrine HCl 5 mg

  • Purpose

    Pain reliever/fever reducer

    Nasal decongestant

  • INDICATIONS & USAGE

    Uses

    temporarily relieves these common cold/flu symptoms:

    • nasal congestion
    • headache
    • minor aches and pains
    • stuffy nose
    • sinus congestion and pressure

    temporarily reduces fever

  • WARNINGS

    Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

    • more than 4,000 mg of acetaminophen in 24 hours
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks every day while using this product

    Allergy alert:

    Acetaminophen may cause severe skin reactions. Symptoms may include:

    • skin reddening
    • blisters
    • rash

    If 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.
    • 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.
    • for more than 10 days unless directed by a doctor

    Ask a doctor before use if you have

    • liver disease
    • thyroid disease
    • diabetes
    • high blood pressure
    • heart disease
    • trouble urinating due to an enlarged prostate gland

    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.

    Stop use and ask a doctor if

    • you get nervous, dizzy, or sleepless
    • pain or nasal congestion gets worse or lasts more than 7 days
    • fever gets worse or lasts more than 3 days
    • redness or swelling is present
    • new symptoms appear

    These could be signs of a serious condition.

    If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children.

    Overdose warning:

    In case of overdose, get medical help or contact a Poison Control Center right away
    (1-800-222-1222).

    Quick medical attention is critical for adults as well as for children even if you do not

    notice any signs or symptoms.

  • DOSAGE & ADMINISTRATION

    Directions

    do not use more than directed

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

    Children under 12 years: Ask a doctor

  • SPL UNCLASSIFIED SECTION

    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 INGREDIENT

    Inactive ingredients

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

    *may contain

    Questions or comments? 1-800-869-6970

  • Green Guard Advanced Sinus Relief Label

    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

    Pain Reliever & Fever Reducer & Nasal Decongestant / Alivia el dolor y reduce la fiebre y descongestivo nasal
    125 Packets of 2 Tablets
    250 Tablets
    Order #2207
    Distributed by Green Guard ®, St Louis, MO 63045

    Green Guard

  • INGREDIENTS AND APPEARANCE
    GREEN GUARD ADVANCED SINUS RELIEF 
    acetaminophen, phenylephrine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47682-001
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CROSPOVIDONE (UNII: 68401960MK)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    Product Characteristics
    Colorwhite (white) Scoreno score
    ShapeROUND (ROUND) Size12mm
    FlavorImprint Code AZ;261
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47682-001-3350 in 1 BOX12/30/2008
    12 in 1 PACKET; Type 0: Not a Combination Product
    2NDC:47682-001-48125 in 1 BOX12/30/2008
    2NDC:47682-001-992 in 1 PACKET; Type 0: Not a Combination Product
    3NDC:47682-001-992 in 1 PACKET; Type 0: Not a Combination Product12/30/2008
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34112/30/2008
    Labeler - Unifirst First Aid Corporation (832947092)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prestige Packaging080667761relabel(47682-001) , repack(47682-001)

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