Label: GREEN GUARD PAIN AND ACHE RELIEF- acetaminophen, aspirin, salicylamide and caffeine tablet

  • NDC Code(s): 47682-003-33, 47682-003-48, 47682-003-99
  • 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 March 16, 2022

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

  • 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 Packaging080667761pack(47682-003)