Label: GREEN GUARD EXTRA STRENGTH PAIN RELIEF- aspirin. caffeine tablet, film coated

  • NDC Code(s): 47682-048-80, 47682-048-99
  • Packager: Unifirst First Aid Corporation
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 16, 2024

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each caplet)

    Aspirin 500 mg (NSAID)*

    Caffeine 32.5 mg

    *nonsteroidal anti-inflammatory drug

  • PURPOSE

    Purpose

    Pain reliever

    Pain reliever aid

  • INDICATIONS & USAGE

    Uses
    for the temporary relief of
    ■ backache pain
    ■ muscle aches and pains
    ■ minor aches and pains of arthritis

  • 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 may cause a severe allergic reaction which may include:

    ■ hives

    ■ shock

    ■ facial swelling

    ■ asthma (wheezing)

    Stomach bleeding warning:

    This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you

    ■ take more or for a longer time than directed

    ■ take a blood thinning (anticoagulant) or steroid drug

    ■ are age 60 or older

    ■ have 3 or more alcohol drinks every day while using this product

    ■ have had stomach ulcers or bleeding problems

    ■ take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)

  • DO NOT USE

    Do not use
    ■ if you are allergic to aspirin or any other pain reliever/fever reducer.
    ■ if you have ever had an allergic reaction to this product or any of its ingredients

  • ASK DOCTOR

    Ask a doctor before use if

    ■ stomach bleeding warning applies to you

    ■ you have a history of stomach problems, such as heartburn

    ■ you have asthma

    ■ you have high blood pressure, heart disease, liver cirrhosis, or kidney disease

    ■ you are taking a diuretic

  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are taking a prescription drug for
    ■ gout
    ■ diabetes
    ■ arthritis

  • STOP USE

    Stop use and ask a doctor if

    ■ an allergic reaction occurs. Seek medical help right away.

    ■ you experience any of the following signs of stomach bleeding: ■ vomit blood ■ have bloody or black stools ■ feel faint ■ have stomach pain that does not get better

    ■ ringing in the ears or a loss of hearing occurs

    ■ pain gets worse or lasts more than 10 days

    ■ fever gets worse or lasts more than 3 days

    ■ redness or swelling is present

    ■ new symptoms occur

    These could be signs of a serious condition.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin at 20 weeks or later in pregnancy unless specifically 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. In case of overdose, get medical help or contact a Poison Control Center
    (1-800-222-1222) right away.

  • DOSAGE & ADMINISTRATION

    Directions

    drink a full glass of water with each dose

    Adults and children: (12 years and over) take 2 caplets every 6 hours, not to exceed 8 caplets in 24 hours

    Children under 12 years: do not use unless directed by a doctor

  • OTHER SAFETY INFORMATION

    Other information

    ■ store at 77°F (25°C) excursions permitted between 59°-86°F (15°-30°C)

    ■ tamper evident sealed packets

    ■ do not use any opened or torn packets

  • INACTIVE INGREDIENT

    Inactive ingredients

    corn starch, hypromellose, maltodextrin, microcrystalline cellulose, polyethylene glycol, sodium lauryl sulfate

  • QUESTIONS

    Questions or comments? 1-800-869-6970

  • PRINCIPAL DISPLAY PANEL

    Extra Strength Pain Relief™

    Green Guard

    Alivio al dolor extra fuerte

    Aspirin (NSAID) / Aspirina (AINE) 500 mg

    Caffeine / Cafeina 32.5 mg

    Pull tp Open

    Tire Para Abrir

    40 packet of 2 Caplets

    80 Caplets

    Order #2180

    Distributed by Green Guard®

    St Louis, MO 63045

    Green Guard

  • INGREDIENTS AND APPEARANCE
    GREEN GUARD EXTRA STRENGTH PAIN RELIEF 
    aspirin. caffeine tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47682-048
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN500 mg
    CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE32.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeCAPSULE (Caplet) Size17mm
    FlavorImprint Code 44;413
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47682-048-8040 in 1 BOX09/26/2022
    1NDC:47682-048-992 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01309/26/2022
    Labeler - Unifirst First Aid Corporation (832947092)