EXTRA STRENGTH BACK AND BODY- aspirin, caffeine tablet, film coated
Walgreen Company

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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Walgreens 44-413-Delisted

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

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
shock
facial swelling
asthma (wheezing)

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

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

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 asthma
you have high blood pressure, heart disease, liver 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

an allergic reaction occurs. Seek medical help right away.
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
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 (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 25ºC (77ºF); excursions permitted between 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

Walgreens

Compare to Bayer® Back &
Body active ingredients††

NDC 0363-0431-15

Back & Body

Aspirin (NSAID) / PAIN RELIEVER / CAFFEINE / PAIN RELIEVER AID

EXTRA STRENGTH

• Temporary relief of backache, muscle aches
& pains, minor aches & pains of arthritis

50 COATED
CAPLETS

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

†Walgreens Pharmacist Survey
††This product is not manufactured or distributed
by Bayer AG, owner of the registered trademark
Bayer® Back & Body.
50844 REV0818A41315

DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015
100% SATISFACTION GUARANTEED
walgreens.com
©2018 Walgreen Co.

Walgreens 44-413

EXTRA STRENGTH BACK AND BODY
aspirin, caffeine tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0363-0431
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	500 mg
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)	CAFFEINE	32.5 mg

Ingredient Name	Strength
Inactive Ingredients
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
Color	white	Score	no score
Shape	OVAL	Size	17mm
Flavor		Imprint Code	44;413
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0363-0431-15	1 in 1 CARTON	04/12/2004	01/24/2022
1		50 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part343	04/12/2004	01/24/2022

Labeler - Walgreen Company (008965063)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		038154464	pack(0363-0431)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867894	manufacture(0363-0431)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		967626305	pack(0363-0431)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		868734088	pack(0363-0431)

Revised: 11/2021

Document Id: 1a4d8c1f-ac5c-4f18-921b-71fb8e6d3b5f

Set id: b8aed83b-e317-4aac-bac2-08766bcbdd71

Version: 11

Effective Time: 20211102

Walgreen Company