Your browser does not support JavaScript! EXTRA STRENGTH BACK AND BODY (ASPIRIN, CAFFEINE) CAPSULE [WALGREEN CO.]
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EXTRA STRENGTH BACK AND BODY (aspirin, caffeine) capsule
[WALGREEN CO.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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.
Drug Label Sections

Active ingredients (in each caplet)

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

  • have had stomach ulcers or bleeding problems, are age 60 or older
  • take a blood thinning (anticoagulant) or steroid drug
  • take other prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
  • have 3 or more alcoholic drinks every day while using this product
  • take more or for a longer time than directed

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, lover 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:
    • feel faint
    • vomit blood
    • have bloody or black stools
    • 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 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 hour
  • children under 12 years: do not use unless directed by a doctor 

Other information

  • store at controlled room temperature 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and 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

Well at
Walgreens
WALGREENS PHARMACIST RECOMMENDEDǂ

NDC 0363-0431-15

EXTRA STRENGTH
Back & Body
Aspirin (NSAID) /
Caffeine / Pain Reliever Aid
• Fast relief at the site of pain

50
COATED CAPLETS

Compare to Bayer® Back & Body active ingredientsǂǂ

ǂWalgreens Pharmacist Survey Study, November 2010.
ǂǂThis product is not manufactured or distributed by Bayer HealthCare, LLC, owner of the registered trademark Bayer® Back & Body.
50844    ORG081041315

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

Walgreens 44-413

Walgreens 44-413

EXTRA STRENGTH BACK AND BODY 
aspirin, caffeine capsule
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0363-0431
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:0363-0431-151 in 1 CARTON
150 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34304/12/2004
Labeler - WALGREEN CO. (008965063)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464PACK(0363-0431)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894MANUFACTURE(0363-0431)

Revised: 3/2013
 
WALGREEN CO.

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