Meijer 44-413

Meijer 44-413

Drug Labeling and Warnings

Drug Details

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BACK AND BODY EXTRA STRENGTH- aspirin, caffeine tablet, film coated 
Meijer Distribution Inc

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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Meijer 44-413

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

  • 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) and 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

44-413

BACK AND BODY  EXTRA STRENGTH
aspirin, caffeine tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 41250-143
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN500 mg
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE32.5 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
Product Characteristics
ColorWHITEScoreno score
ShapeOVALSize17mm
FlavorImprint Code 44;413
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 41250-143-121 in 1 CARTON04/12/2014
1100 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34304/12/2014
Labeler - Meijer Distribution Inc (006959555)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464PACK(41250-143)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894MANUFACTURE(41250-143)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.967626305PACK(41250-143)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.868734088PACK(41250-143)

Revised: 3/2019
 
Meijer Distribution Inc


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