Back And Body Extra Strength (Aspirin, Caffeine) Tablet, Film Coated [Meijer Distribution Inc] -

BACK AND BODY EXTRA STRENGTH (ASPIRIN, CAFFEINE) TABLET, FILM COATED [MEIJER DISTRIBUTION INC]
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NDC	41250-143-12
Set ID	e513f2d9-d591-4790-a117-6176ce2279dc
Category	HUMAN OTC DRUG LABEL
Packager	Meijer Distribution Inc
Generic Name
Product Class
Product Number
Application Number	PART343

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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
- facial swelling
- shock
- asthma (wheezing)
Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you
- are age 60 or older
- 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
- have had stomach ulcers or bleeding problems
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 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
- an allergic reaction occurs. Seek medical help right away.
- you experience any of the following signs of stomach bleeding:
  - vomit blood
  - have bloody or black stools
  - feel faint
  - 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

NDC 41250-143-12

Compare to Bayer® Back & Body active ingredients†

meijer®

EXTRA STRENGTH

back & body
Aspirin (NSAID) | Caffeine
Pain Reliever | Pain Reliever Aid

100
CAPLETS Actual Size

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

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

50844 REV0818A41312

DIST. BY MEIJER
DISTRIBUTION, INC.
GRAND RAPIDS, MI 49544
www.meijer.com

44-413

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:41250-143
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)
CELLULOSE, MICROCRYSTALLINE (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
Packaging
1	NDC:41250-143-12	1 in 1 CARTON	04/12/2014
1		100 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	04/12/2014

Labeler - Meijer Distribution Inc (006959555)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		038154464	PACK(41250-143)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867894	MANUFACTURE(41250-143)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		967626305	PACK(41250-143)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		868734088	PACK(41250-143)

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Medic

BACK AND BODY EXTRA STRENGTH (ASPIRIN, CAFFEINE) TABLET, FILM COATED [MEIJER DISTRIBUTION INC]

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.

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