BAYER BACK AND BODY EXTRA STRENGTH- aspirin,caffeine tablet 
Bayer HealthCare LLC.

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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Bayer Back & Body - Extra Strength

Drug Facts

Drug Facts

Active ingredients (in each caplet)

*
nonsteroidal anti-inflammatory drug
Active ingredients (in each caplet)Purpose
Aspirin 500 mg (NSAID) *Pain reliever
Caffeine 32.5 mgPain reliever aid

Purpose

Uses

for the temporary relief of

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:

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

Do not use

Ask a doctor before use if

Ask a doctor or pharmacist before use if you are taking a prescription drug for

Stop use and ask a doctor if

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

Other Information

Inactive Ingredients

carnauba wax, corn starch, D&C red #30 aluminum lake, D&C yellow #10 aluminum lake, hypromellose, powdered cellulose, propylene glycol, shellac, titanium dioxide, triacetin

Questions or comments? 1-800-331-4536 (Mon-Fri 9AM - 5PM EST)

Carton label 24 count

BAYER BACK AND BODY  EXTRA STRENGTH
aspirin,caffeine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0280-2150
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE35.5 mg
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN500 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SHELLAC (UNII: 46N107B71O)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
TRIACETIN (UNII: XHX3C3X673)  
Product Characteristics
ColorwhiteScoreno score
ShapeOVALSize19mm
FlavorImprint Code BAYER;BACK;BODY
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0280-2150-241 in 1 CARTON01/12/2015
124 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC:0280-2150-501 in 1 CARTON01/12/2015
250 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3NDC:0280-2150-101 in 1 CARTON01/12/2015
3100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
4NDC:0280-2150-02200 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/12/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34301/12/2015
Labeler - Bayer HealthCare LLC. (112117283)

Revised: 8/2017
Document Id: 55c4de2b-84ce-1497-e054-00144ff88e88
Set id: 0c77c484-6caf-12ca-e054-00144ff88e88
Version: 2
Effective Time: 20170802
 
Bayer HealthCare LLC.