BACK AND BODY EXTRA STRENGTH (ASPIRIN, CAFFEINE) TABLET [GREENBRIER INTERNATIONAL, INC.]

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  • BACK AND BODY EXTRA STRENGTH (ASPIRIN, CAFFEINE) TABLET [GREENBRIER INTERNATIONAL, INC.]

BACK AND BODY EXTRA STRENGTH (ASPIRIN, CAFFEINE) TABLET [GREENBRIER INTERNATIONAL, INC.]
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NDC 33992-0413-2, 33992-0413-8
Set ID 0c268719-aecb-4aa0-a96d-137cd019d78d
Category HUMAN OTC DRUG LABEL
Packager GREENBRIER INTERNATIONAL, INC.
Generic Name
Product Class
Product Number
Application Number PART343
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  • Active ingredients (in each caplet)

    Aspirin 500 mg (NSAID)*
    Caffeine 32.5 mg
    *nonsteroidal anti-inflammatory drug

  • Purpose

    Pain reliever
    Pain reliever aid

  • Uses

    for the temporary relief of

    • backache pain
    • muscle aches and pains
    • minor aches and pains of arthritis
  • 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
    • facial swelling
    • shock
    • asthma (wheezing)

    Stomach bleeding warning: This product contains and NSAID, which may cause severe stomach bleeding. The chance is higher if you

    • are age 60 or older
    • take more or for a longer time than directed
    • 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

    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 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 a doctor or pharmacist before use if you are

    taking a prescription drug for

    • gout
    • diabetes
    • arthritis

    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.

    If pregnant or breast-feeding,

    ask a health professional before use. It is especially important not to use aspirin 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.

    In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • 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 information

    • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
    • see end flap for expiration date or lot number 
  • Inactive ingredients

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

  • Questions or comments?

    1-800-426-9391

  • Principal Display Panel

    ASSURED™

    COMPARE TO ACTIVE INGREDIENTS OF
    BAYER® Back & Body†

    EXTRA STRENGTH
    Back & Body
    • Aspirin (NSAID) & Caffeine
    Pain Reliever / Pain reliever aid

    Actual Size

    24 coated caplets

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED
    SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

    †This product is not manufactured or distributed by Bayer
    HealthCare LLC, owner of the registered trademark Bayer®
    Back & Body.                       50844            REV0818D41308

    ITEM# 125702
    Distributed by: Greenbrier International, Inc.
    Chesapeake, VA 23320 USA

    44-413

    44-413

  • INGREDIENTS AND APPEARANCE
    BACK AND BODY  EXTRA STRENGTH
    aspirin, caffeine tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:33992-0413
    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
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeOVALSize17mm
    FlavorImprint Code 44;413
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:33992-0413-81 in 1 CARTON04/12/2004
    124 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:33992-0413-21 in 1 CARTON04/12/200403/29/2019
    248 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34304/12/2004
    Labeler - GREENBRIER INTERNATIONAL, INC. (610322518)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464PACK(33992-0413)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894MANUFACTURE(33992-0413)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305PACK(33992-0413)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088PACK(33992-0413)
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