EXTRA STRENGTH BACK AND BODY- aspirin and caffeine capsule 
WOONSOCKET PRESCRIPTION CENTER,INCORPORATED

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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CVS 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:

  • 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
  • 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
  • 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 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:

  • feel faint
  • have bloody or black stool
  • vomit blood
  • have stomach pain that does nt get better
  • an allergic reaction occurs. Seek medical help right away.
  • new symptoms occur
  • rining 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

  • 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 controlled room temperature 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

CVS®
pharmacy

Compare to the active ingredients in Extra Strength Bayer® Back & Body Pain Caplets** 

Extra Strength
BACK & BODY
PAIN RELIEVER/PAIN RELIEVER AID
GENUINE ASPIRIN (NSAID) & CAFFEINE

Fast pain relief, exactly where you need it

100 COATED CAPLETS

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

50844    REV0810B41312

Distributed by: CVS Pharmacy, Inc.
One CVS Drive
Woonsocket, RI 02895
©2011 CVS/pharmacy
www.cvs.com    1-800-shop-CVS

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL UNDER CAP IS BROKEN OR MISSING
#695034

CVS 44-413

CVS 44-413

EXTRA STRENGTH BACK AND BODY 
aspirin, caffeine capsule
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:59779-143
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:59779-143-121 in 1 CARTON
1100 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34304/12/2004
Labeler - WOONSOCKET PRESCRIPTION CENTER,INCORPORATED (062312574)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464PACK(59779-143, 59779-143)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894MANUFACTURE(59779-143, 59779-143)

Revised: 9/2012
Document Id: 0b31299b-9f33-4a41-9bb2-5f515c6b400f
Set id: 749e2be2-594a-4052-8fa5-45c9ade2d23c
Version: 1
Effective Time: 20120919
 
WOONSOCKET PRESCRIPTION CENTER,INCORPORATED