GREEN GUARD MAXIMUM NON-ASPIRIN (ACETAMINOPHEN) TABLET, FILM COATED [UNIFIRST FIRST AID CORPORATION]

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  • GREEN GUARD MAXIMUM NON-ASPIRIN (ACETAMINOPHEN) TABLET, FILM COATED [UNIFIRST FIRST AID CORPORATION]

GREEN GUARD MAXIMUM NON-ASPIRIN (ACETAMINOPHEN) TABLET, FILM COATED [UNIFIRST FIRST AID CORPORATION]
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NDC 47682-010-33, 47682-010-48, 47682-010-99
Set ID d3bb51a1-59f4-43a5-b2cd-8fc8e6874a53
Category HUMAN OTC DRUG LABEL
Packager Unifirst First Aid Corporation
Generic Name
Product Class
Product Number
Application Number PART343
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient (in each tablet)

    Acetaminophen 500 mg

  • PURPOSE

    Purpose

    Pain reliever/fever reducer

  • INDICATIONS & USAGE

    Uses

    temporarily relieves minor aches and pains due to:

    • headache
    • muscular aches
    • backache
    • minor pain of arthritis
    • the common cold
    • toothache
    • premenstrual and menstrual cramps

    temporarily reduces fever

  • WARNINGS

    Warnings

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

    ■ more than 4,000 mg 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

    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 allergic to acetaminophen or any of the inactive ingredients in this product

    Ask a doctor before use if you have

    • liver disease

    Ask a doctor or pharmacist before use if

    • you are taking the blood thinning drug warfarin

    Stop use and ask a doctor if

    • pain gets worse or lasts more than for more than 10 days
    • fever gets worse or lasts more than 3 days
    • new symptoms occur
    • redness or swelling is present

    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 (see overdose warning)

    ​

    Adults and children 12 years and over ■ take 2 tablets every 6 hours while symptoms last.
    ■ do not take more than 6 tablets in 24 hours, unless directed by a doctor

    ■ do not use for more than 10 days unless directed by a doctor

    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
  • INACTIVE INGREDIENT

    Inactive ingredients corn starch, hypromellose, maltodextrin*, microcrystalline cellulose*, polyethylene glycol, povidone, pregelatinized starch*, sodium starch glycolate, stearic acid, titanium dioxide*

    * m ay contain

  • QUESTIONS

    Questions or comments? 1-800-869-6970

  • Green Guard Max Non-Aspirin 500 mg Label

    Maximum Strength

    Non-Aspirin relief™

    Compare Active Ingredient To Extra Strength Tylenol®

    Pull to Open

    Tire Para Abrir

    Acetaminophen 500 mg/Acetaminofeno 500 mg

    Pain Reliever/Fever Reducer

    Alivia el Dolor/Reduce la Fiebre

    Green Guard®

    Tylenol® is a Registered Trademark of McNeil Consumer Products

    50 Packets of 2 Tablets

    100 Tablets

    Order #2224

    Distributed by Green Guard® St Louis. MO 63045

    GG Max

  • INGREDIENTS AND APPEARANCE
    GREEN GUARD MAXIMUM NON-ASPIRIN 
    acetaminophen tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47682-010
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    Colorwhite (white) Scoreno score
    ShapeROUND (ROUND) Size12mm
    FlavorImprint Code FR;33
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47682-010-3350 in 1 BOX12/30/2008
    1NDC:47682-010-992 in 1 PACKET; Type 0: Not a Combination Product
    2NDC:47682-010-48125 in 1 BOX12/30/2008
    2NDC:47682-010-992 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34312/30/2008
    Labeler - Unifirst First Aid Corporation (832947092)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prestige Packaging080667761relabel(47682-010) , repack(47682-010)
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