BACK AND BODY EXTRA STRENGTH- aspirin, caffeine tablet, film coated 
Cardinal Health

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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Leader 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 an 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
  • 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 high blood pressure, heart disease, liver cirrhosis, or kidney disease
  • you have asthma
  • 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:
    • feel faint
    • have bloody or black stools
    • vomit blood
    • 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 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

LEADER

NDC 70000-0127-2

Extra Strength
Back & Body
Aspirin (NSAID), 500 mg | Caffeine, 32.5 mg
Pain Reliever | Pain Reliever Aid

Relieves Backaches
and Muscle Aches & Pains

COMPARE TO
BAYER® BACK & BODY

active ingredients

100% Money Back Guarantee

100 CAPLETS

Actual Size

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

This product is not manufactured or distributed by Bayer AG, owner of the registered trademark Bayer® Back & Body.
50844   REV0818A41312

CardinalHealth™
DISTRIBUTED BY CARDINAL HEALTH
DUBLIN, OHIO 43017
www.myleader.com 1-800-200-6313
Essential to Care™ since 1979

100%
Money Back Guarantee

Return to place of purchase if not satisfied.

© 2021 Cardinal Health. All Rights Reserved. CARDINAL HEALTH, the Cardinal Health LOGO, ESSENTIAL TO CARE,
LEADER, and the Leader LOGO are trademarks or registered trademarks of Cardinal Health. All other marks are the
property of their respective owners.

Leader 44-413

Leader 44-413

BACK AND BODY  EXTRA STRENGTH
aspirin, caffeine tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0127
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
STARCH, CORN (UNII: O8232NY3SJ)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
Product Characteristics
ColorwhiteScoreno score
ShapeOVALSize17mm
FlavorImprint Code 44;413
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70000-0127-11 in 1 CARTON04/12/2004
150 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC:70000-0127-21 in 1 CARTON04/12/2004
2100 in 1 BOTTLE, PLASTIC; 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 - Cardinal Health (097537435)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894manufacture(70000-0127)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464pack(70000-0127)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.967626305pack(70000-0127)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.868734088pack(70000-0127)

Revised: 3/2021
Document Id: 727d4490-864e-46a1-8e49-45c1d5270e8d
Set id: 519eb216-9fa6-4d60-a2a4-3310bdb5b4ab
Version: 9
Effective Time: 20210322
 
Cardinal Health