GREEN GUARD PAIN AND ACHE RELIEF (ACETAMINOPHEN, ASPIRIN, SALICYLAMIDE AND CAFFEINE) TABLET [UNIFIRST FIRST AID CORPORATION]

GREEN GUARD PAIN AND ACHE RELIEF (ACETAMINOPHEN, ASPIRIN, SALICYLAMIDE AND CAFFEINE) TABLET [UNIFIRST FIRST AID CORPORATION]
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NDC 47682-003-33, 47682-003-48, 47682-003-99
Set ID 89beca67-8ae0-439b-8964-2bf194e9ca82
Category HUMAN OTC DRUG LABEL
Packager Unifirst First Aid Corporation
Generic Name
Product Class
Product Number
Application Number PART343
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient (in each tablet)

    Acetaminophen 110 mg

    Aspirin (NSAID)* 162 mg

    Caffeine 32.4 mg

    Salicylamide (NSAID)* 152 mg

    *nonsteroidal anti-inflammatory drug

  • PURPOSE

    Purpose

    Pain reliever/Fever reducer

    Pain reliever/Fever reducer

    Adjuvant

    Pain reliever aid

  • INDICATIONS & USAGE

    Uses

    temporarily relieves minor aches and pains associated with

    • headache
    • muscular aches
    • minor arthritis pain
    • back pain
    • colds
    • toothache
    • menstrual cramps

    Temporarily reduces fever.

  • WARNINGS

    Warnings

    Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.

    Allergy alert: Aspirin (NSAIDs) may cause a severe allergic reaction which may include:

    ■ hives ■ facial swelling ■ asthma (wheezing) ■ shock

    Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

    ■ skin reddening ■ blisters ■ rash

    If a skin or allergic reaction occurs, stop use and seek medical help right away.

  • SPL UNCLASSIFIED SECTION

    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
  • SPL UNCLASSIFIED SECTION

    Stomach bleeding warning: This product contains nonsteriodal anti-inflammatory drugs (NSAIDs), which may cause severe stomach bleeding. The chance is higher if you:

    • are age 60 or older
    • have had stomach ulcers or bleeding problems
    • take a blood thinning (anticoagulant) or steroid drug
    • take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
    • have 3 or more alcoholic drinks every day while using this product
    • take more or for a longer time than directed
  • SPL UNCLASSIFIED SECTION

    Caffeine warning: The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine- containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heart beat

  • DO NOT USE

    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 pain for more than 10 days unless directed by a doctor
    • for more than 3 days for fever unless directed by a doctor
    • with any other pain reliever/fever reducer
  • ASK DOCTOR

    Ask a doctor before use if

    • stomach bleeding warning applies to you
    • you have a history of stomach problems (such as heartburn, upset stomach or stomach pain)
    • you have heart disease, liver cirrhosis, or kidney disease
    • you have asthma or high blood pressure
    • you are taking a diuretic
  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are taking a prescription drug for

    ■ anticoagulation

    ■ diabetes

    ■ gout

    ■ arthritis

    Ask a doctor or pharmacist before use if you have

    ■ liver disease

  • WHEN USING

    When using this product do not exceed recommended dose

  • STOP USE

    Stop use and ask a doctor if

    • you experience any of the following signs of stomach bleeding: ■ feel faint ■ vomit blood ■ have bloody or black stools ■ have stomach pain that does not get better
    • symptoms do not improve
    • pain or fever gets worse
    • ringing in the ears or loss of hearing occurs
    • new symptoms occur
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health care professional before use. It is especially important not to use aspirin and salicylamide during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

    Overdose warning:

    Taking more than the recommended dose (overdose) may cause liver damage.

    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.

  • DOSAGE & ADMINISTRATION

    Directions

    • do not use more than directed

    Adults and children(12 years and older): take 2 tablets every 4 hours as needed with a full glass of water. Do not exceed 8 tablets in 24 hours or as directed by a doctor.

    Children under 12 years of age: ask a doctor

  • OTHER SAFETY INFORMATION

    Other information

    • store at room temperature 59º-86ºF (15º-30ºC)
    • avoid excessive heat and humidity
    • tamper evident sealed packets
    • do not use any opened or torn packets
  • INACTIVE INGREDIENT

    Inactive ingredients

    FD&C yellow #6, magnesium stearate, microcrystalline cellulose, povidone, starch, stearic acid.

  • QUESTIONS

    Questions or Comments? 1-800-869-6970

  • Green Guard Pain & Ache Relief

    Pain & Ache Relief™

    Tabletas para aliviar el doior

    Green Guard®

    Pull Out

    Tire Para Abrir

    Acetaminophen/Acetaminofeno 110 mg

    Aspirin (NSAID)/Aspirina (AINE) 162 mg

    Salicylamide (NSAID)/ Salicilamida (AINE)152 mg

    Caffeine/Cafeina 32.4 mg

    Pain Reliever & Fever Reducer/ Alivia el dolor y reduce la fiebre

    125 packets of 2 tablets

    250 Tablets Order #2210

    Distributed by Green Guard®, St Louis, MO 63045

    Green Guard

  • INGREDIENTS AND APPEARANCE
    GREEN GUARD PAIN AND ACHE RELIEF 
    acetaminophen, aspirin, salicylamide and caffeine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47682-003
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN110 mg
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN162 mg
    SALICYLAMIDE (UNII: EM8BM710ZC) (SALICYLAMIDE - UNII:EM8BM710ZC) SALICYLAMIDE152 mg
    CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE32.4 mg
    Inactive Ingredients
    Ingredient NameStrength
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    Colororange (orange) Scoreno score
    ShapeROUND (ROUND) Size11mm
    FlavorImprint Code FR;2
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47682-003-3350 in 1 BOX12/30/2008
    12 in 1 PACKET; Type 0: Not a Combination Product
    2NDC:47682-003-48125 in 1 BOX12/30/2008
    2NDC:47682-003-992 in 1 PACKET; Type 0: Not a Combination Product
    3NDC:47682-003-992 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 not finalpart34312/30/2008
    Labeler - Unifirst First Aid Corporation (832947092)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prestige Packaging080667761relabel(47682-003) , repack(47682-003)

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