Label: GREEN GUARD MAXIMUM NON-ASPIRIN- acetaminophen tablet, film coated

  • NDC Code(s): 47682-009-33, 47682-009-48, 47682-009-99
  • Packager: Unifirst First Aid Corporation
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated October 29, 2018

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredient (in each tablet)

    Acetaminophen 500 mg

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  • Purpose

    Pain reliever/fever reducer

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  • Uses

    For the temporary relief of minor aches and pains associated with

    • headache
    • toothache
    • minor arthritis pain
    • muscular aches
    • common cold
    • menstrual cramps

    For the reduction of fever.

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  • 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

    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.
    • for more than 10 days for pain unless directed by a doctor
    • for more than 3 days for fever unless directed by a doctor

    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 using and ask a doctor if

    • symptoms do not improve
    • pain or fever persists or gets worse
    • new symptoms occur
    • redness or swelling is present

    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep out of reach of children.

    In case of accidental 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.

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  • Directions

    • do not use more than directed

    Adults and children: (12 years and older)

    Take 2 tablets every 4 to 6 hours as needed. 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.

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  • Other information

    • store at room temperature 59º-86ºF (15º-30ºC)
    • tamper-evident sealed packets
    • do not use any opened or torn packets
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  • Inactive ingredients

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

    * m ay contain

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  • QUESTIONS

    Questions or comments? 1-800-869-6970

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  • Green Guard Max Non-Aspirin Label

    Maximum Strength

    Non-Aspirin

    relief

    Compare Active Ingredient To Extra Strength Tylenol®

    Green Guard®

    Pull Out

    Tire Para Abrir

    Acetaminophen 500 mg/Acetaminofeno 500 mg

    Pain Reliever/Fever Reducer

    Alivia el Dolor/Reduce la Fiebre

    Tylenol® is a Registered Trademark of McNeil Consumer Products

    125 Packets of 2 Tablets

    250 Tablets

    Order #2222

    Distributed by Green Guard® St Louis. MO 63045

    An FDA Regulated Facility

    Green Guard

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  • INGREDIENTS AND APPEARANCE
    GREEN GUARD MAXIMUM NON-ASPIRIN 
    acetaminophen tablet, film coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:47682-009
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg
    Inactive Ingredients
    Ingredient Name Strength
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Color white (white) Score no score
    Shape ROUND (ROUND) Size 12mm
    Flavor Imprint Code AZ;235
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:47682-009-33 50 in 1 BOX, UNIT-DOSE 12/30/2008
    1 NDC:47682-009-99 2 in 1 PACKET; Type 0: Not a Combination Product
    2 NDC:47682-009-48 125 in 1 BOX, UNIT-DOSE 12/30/2008
    2 NDC:47682-009-99 2 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part343 12/30/2008
    Labeler - Unifirst First Aid Corporation (832947092)
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