EXTRA STRENGTH BACK AND BODY- aspirin and caffeine capsule 
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 ingredient (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 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

  • you experience any of the following signs of stomach bleeding:
    • have bloody for black stools
    • vomit blood
    • feel faint
    • have stomach pain that does not get better
  • an allergic reaction occurs.  Seeks 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 IN BAYER® Back & Body

EXTRA STRENGTH
BACK & BODY
• Aspirin (NSAID) & Caffeine
Pain Reliever / Pain Reliever Aid

48 COATED CAPLETS

†This product is not manufactured or distributed by Bayer HealthCare LLC, owner of the registered trademark Bayer® Back & Body.
50844    ORG011341322


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

Assured 44-413

Assured 44-413

EXTRA STRENGTH BACK AND BODY 
aspirin, caffeine capsule
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:33992-0413
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (ASPIRIN) ASPIRIN500 mg
CAFFEINE (CAFFEINE) CAFFEINE32.5 mg
Inactive Ingredients
Ingredient NameStrength
SODIUM LAURYL SULFATE 
Product Characteristics
ColorWHITEScoreno score
ShapeCAPSULESize19mm
FlavorImprint Code 44;413
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:33992-0413-21 in 1 CARTON
148 in 1 BOTTLE
2NDC:33992-0413-81 in 1 CARTON
224 in 1 BOTTLE
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)

Revised: 3/2014
Document Id: 41f027e3-ca21-4555-8b92-2ba53fd605f0
Set id: 0c268719-aecb-4aa0-a96d-137cd019d78d
Version: 2
Effective Time: 20140324
 
GREENBRIER INTERNATIONAL, INC.