BACK AND BODY EXTRA STRENGTH- aspirin and caffeine tablet 
GREENBRIER INTERNATIONAL, INC.

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.

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Assured 44-413

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:

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:

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

Do not use

if you are allergic to aspirin or any other pain reliever/fever reducer.

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

  • you experience any of the following signs of stomach bleeding:
    • have bloody or black stools
    • vomit blood
    • feel faint
    • have stomach pain that does not get better
  • an allergic reaction occurs. Seek medical help right away.
  • new symptoms occur
  • ringing in the ears or 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
  • 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

Other information

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

This product is not manufactured or distributed by Bayer HealthCare LLC, owner of the registered trademark Bayer® Back & Body.
50844    REV0113C41308

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

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

Assured 44-413

Assured 44-413

BACK AND BODY  EXTRA STRENGTH
aspirin, caffeine tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:33992-0413
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 500 mg
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE 32.5 mg
Inactive Ingredients
Ingredient Name Strength
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
STARCH, CORN (UNII: O8232NY3SJ)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
Product Characteristics
Color WHITE Score no score
Shape OVAL Size 19mm
Flavor Imprint Code 44;413
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:33992-0413-2 1 in 1 CARTON
1 48 in 1 BOTTLE; Type 0: Not a Combination Product
2 NDC:33992-0413-8 1 in 1 CARTON
2 24 in 1 BOTTLE; 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 04/12/2004
Labeler - GREENBRIER INTERNATIONAL, INC. (610322518)
Establishment
Name Address ID/FEI Business Operations
LNK International, Inc. 038154464 PACK(33992-0413)
Establishment
Name Address ID/FEI Business Operations
LNK International, Inc. 832867894 MANUFACTURE(33992-0413)

Revised: 10/2014
Document Id: 79b2deea-0137-4322-8d3d-24568ef9afef
Set id: 0c268719-aecb-4aa0-a96d-137cd019d78d
Version: 3
Effective Time: 20141006
 
GREENBRIER INTERNATIONAL, INC.