Extra Strength Back and Body

WALGREEN CO.

Walgreens 44-413

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredients (in each caplet)
• Purpose
• Extra Strength Back and Body Uses
• Warnings
  • Do not use
  • Ask a doctor before use if
  • Ask a doctor or pharmacist before use if you are
  • Stop use and ask a doctor if
  • If pregnant or breast-feeding,
  • Keep out of reach of children.
• Directions
• Extra Strength Back and Body Other information
• Inactive ingredients
• Questions or Comments?
• Principal display panel

FULL PRESCRIBING INFORMATION

Active ingredients (in each caplet)

Acetaminophen 500 mg (NSAID)*
Caffeine 32.5 mg

*nonsteroidal anti-inflammatory drug 

Purpose

Pain reliever
Pain reliever aid 

Extra Strength Back and Body 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 

Extra Strength Back and Body 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