Bayer Back and Body

Manufacturer
Bayer HealthCare LLC.
Effective date
2025-04-10
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 00:58:56

Label at a glance#

ProductBayer Back and Body Extra Strength
Active ingredientCAFFEINE, ASPIRIN
Label structure15 sections

Indications and uses

for the temporary relief of backache pain muscle aches and pains minor aches and pains of arthritis

Dosage and administration

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: consult a doctor

Label contents#

Full prescribing information#

Drug Facts

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each caplet)Purpose
Aspirin 500 mg (NSAID) * Pain reliever
Caffeine 32.5 mgPain reliever aid

* nonsteroidal anti-inflammatory drug

Uses

INDICATIONS & USAGE SECTION

for the temporary relief of

  • backache pain
  • muscle aches and pains
  • minor aches and pains of arthritis

Warnings

WARNINGS SECTION

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
  • asthma (wheezing)
  • shock

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
  • have had stomach ulcers or bleeding problems
  • 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

Do not use

OTC - DO NOT USE SECTION

  • 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

OTC - ASK DOCTOR SECTION

  • 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 are taking a diuretic
  • you have asthma

OTC - ASK DOCTOR/PHARMACIST SECTION

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

OTC - STOP USE SECTION

  • 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
  • pain gets worse or lasts more than 10 days
  • redness or swelling is present
  • new symptoms occur
  • ringing in the ears or a loss of hearing occurs

OTC - PREGNANCY OR BREAST FEEDING SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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: consult a doctor

Other Information

OTHER SAFETY INFORMATION

  • save carton for full directions and warnings
  • store at room temperature. Avoid excessive heat above 40°C (104°F).

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Carton label 24 countCarton label 24 count

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ASPIRIN Pharmacologic Class Indexing3Indexing - Pharmacologic Class20191108
CAFFEINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
d7724692-1155-4cc8-a415-22f5fc4aec35Product name620220216
bde672ba-4805-28d0-1986-73543d41b412Product name220210201
2dc76302-91c0-4c35-ad78-99adfb049c4bProduct name120200603
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
9425d234-4ae1-4b53-adc6-8cc7af6dd657Product name120150929
2a21311a-89e2-0e83-2ebd-117f9798b2b2Product name120140508
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
9007e8a7-ff50-f9b9-7945-f2a1deadd94eProduct name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508
d223c173-c39b-d764-47d4-d671d3088815Product name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0280-2150-01Bayer Back and BodyExtra Strength1 in 1 CARTONTABLET17
0280-2150-01Bayer Back and BodyExtra Strength6 in 1 BOTTLE, PLASTICTABLET67
0280-2150-02Bayer Back and BodyExtra Strength200 in 1 BOTTLE, PLASTICTABLET2007
0280-2150-03Bayer Back and BodyExtra Strength250 in 1 BOTTLETABLET2507
0280-2150-10Bayer Back and BodyExtra Strength100 in 1 BOTTLE, PLASTICTABLET1007
0280-2150-10Bayer Back and BodyExtra Strength1 in 1 CARTONTABLET17
0280-2150-24Bayer Back and BodyExtra Strength24 in 1 BOTTLE, PLASTICTABLET247
0280-2150-24Bayer Back and BodyExtra Strength1 in 1 CARTONTABLET17
0280-2150-50Bayer Back and BodyExtra Strength50 in 1 BOTTLE, PLASTICTABLET507
0280-2150-50Bayer Back and BodyExtra Strength1 in 1 CARTONTABLET17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0280-2150BAYER BACK AND BODY EXTRA STRENGTH (ASPIRIN,CAFFEINE) TABLET [BAYER HEALTHCARE LLC.]7Current NDC, Legacy NDC, 10 package rows20250411_0c77c484-6caf-12ca-e054-00144ff88e88.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ASPIRINACTIVE INGREDIENTR16CO5Y76E1
CAFFEINEACTIVE INGREDIENT3G6A5W338E1
ASPIRINACTIVE MOIETYR16CO5Y76E1
CAFFEINEACTIVE MOIETY3G6A5W338E1
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O69331
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZ1
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808B1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3G1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WO1
POWDERED CELLULOSEINACTIVE INGREDIENTSMD1X3XO9M1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V31
SHELLACINACTIVE INGREDIENT46N107B71O1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJ1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JP1
TRIACETININACTIVE INGREDIENTXHX3C3X6731

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0280-21500280-2150-24, 0280-2150-50, 0280-2150-10, 0280-2150-02, 0280-2150-01, 0280-2150-03

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 2 · 77 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
POWDERED CELLULOSEPOWDERED CELLULOSESMD1X3XO9MTABLET / ORAL1582 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
CARNAUBA WAXCARNAUBA WAXR12CBM0EIZTABLET / ORAL167.8 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET / ORAL232 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
POWDERED CELLULOSEPOWDERED CELLULOSESMD1X3XO9MTABLET / ORAL1582 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
ALUMINUM OXIDEALUMINUM OXIDELMI26O6933TABLET / ORALNAExact identifier — unii+route+dosage form
7 equally ranked IID candidates
ALUMINUM OXIDEALUMINUM OXIDELMI26O6933TABLET / ORALNAExact identifier — unii+route+dosage form
7 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET / ORAL232 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
TRIACETINTRIACETINXHX3C3X673TABLET / ORAL208 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
D&C YELLOW NO. 10D&C YELLOW NO. 1035SW5USQ3GTABLET / ORAL80 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
D&C RED NO. 30D&C RED NO. 302S42T2808BTABLET / ORAL19 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
D&C RED NO. 30D&C RED NO. 302S42T2808BTABLET / ORAL19 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
SHELLACSHELLAC46N107B71OTABLET / ORAL112 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET / ORAL1127 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET / ORAL1116 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
SHELLACSHELLAC46N107B71OTABLET / ORAL112 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
D&C YELLOW NO. 10D&C YELLOW NO. 1035SW5USQ3GTABLET / ORAL80 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
SHELLACSHELLAC46N107B71OTABLET / ORAL112 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET / ORAL1127 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
TRIACETINTRIACETINXHX3C3X673TABLET / ORAL208 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET / ORAL1127 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
POWDERED CELLULOSEPOWDERED CELLULOSESMD1X3XO9MTABLET / ORAL1582 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
POWDERED CELLULOSEPOWDERED CELLULOSESMD1X3XO9MTABLET / ORAL1582 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
ALUMINUM OXIDEALUMINUM OXIDELMI26O6933TABLET / ORALNAExact identifier — unii+route+dosage form
7 equally ranked IID candidates
TRIACETINTRIACETINXHX3C3X673TABLET / ORAL208 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
SHELLACSHELLAC46N107B71OTABLET / ORAL112 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
POWDERED CELLULOSEPOWDERED CELLULOSESMD1X3XO9MTABLET / ORAL1582 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
TRIACETINTRIACETINXHX3C3X673TABLET / ORAL208 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET / ORAL232 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET / ORAL1116 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET / ORAL1127 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
ALUMINUM OXIDEALUMINUM OXIDELMI26O6933TABLET / ORALNAExact identifier — unii+route+dosage form
7 equally ranked IID candidates
D&C RED NO. 30D&C RED NO. 302S42T2808BTABLET / ORAL19 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET / ORAL1116 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET / ORAL1116 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET / ORAL1127 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
SHELLACSHELLAC46N107B71OTABLET / ORAL112 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
CARNAUBA WAXCARNAUBA WAXR12CBM0EIZTABLET / ORAL167.8 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET / ORAL1116 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
D&C RED NO. 30D&C RED NO. 302S42T2808BTABLET / ORAL19 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET / ORAL1127 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
CARNAUBA WAXCARNAUBA WAXR12CBM0EIZTABLET / ORAL167.8 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3TABLET / ORAL64 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET / ORAL232 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3TABLET / ORAL64 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET / ORAL232 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3TABLET / ORAL64 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
POWDERED CELLULOSEPOWDERED CELLULOSESMD1X3XO9MTABLET / ORAL1582 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
TRIACETINTRIACETINXHX3C3X673TABLET / ORAL208 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
D&C RED NO. 30D&C RED NO. 302S42T2808BTABLET / ORAL19 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3TABLET / ORAL64 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
CARNAUBA WAXCARNAUBA WAXR12CBM0EIZTABLET / ORAL167.8 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
ALUMINUM OXIDEALUMINUM OXIDELMI26O6933TABLET / ORALNAExact identifier — unii+route+dosage form
7 equally ranked IID candidates
D&C YELLOW NO. 10D&C YELLOW NO. 1035SW5USQ3GTABLET / ORAL80 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
ALUMINUM OXIDEALUMINUM OXIDELMI26O6933TABLET / ORALNAExact identifier — unii+route+dosage form
7 equally ranked IID candidates
D&C YELLOW NO. 10D&C YELLOW NO. 1035SW5USQ3GTABLET / ORAL80 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
SHELLACSHELLAC46N107B71OTABLET / ORAL112 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
POWDERED CELLULOSEPOWDERED CELLULOSESMD1X3XO9MTABLET / ORAL1582 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
SHELLACSHELLAC46N107B71OTABLET / ORAL112 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
CARNAUBA WAXCARNAUBA WAXR12CBM0EIZTABLET / ORAL167.8 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
ALUMINUM OXIDEALUMINUM OXIDELMI26O6933TABLET / ORALNAExact identifier — unii+route+dosage form
7 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bayer Back and Body Extra StrengthASPIRIN,CAFFEINEBayer HealthCare LLC.0c77c484-6caf-12ca-e054-00144ff88e882025-04-10WarningsExact identifier
ndc (package): 0280-2150-24
ndc (package): 0280-2150-01
ndc (package): 0280-2150-02
ndc (package): 0280-2150-10
ndc (package): 0280-2150-50
ndc (package): 0280-2150-03
ndc (product): 0280-2150
ndc11 (package): 00280215003
ndc11 (package): 00280215001
ndc11 (package): 00280215024
ndc11 (package): 00280215050
ndc11 (package): 00280215002
ndc11 (package): 00280215010
spl id: 32715f4e-2d90-9bff-e063-6394a90a4aab
spl set id: 0c77c484-6caf-12ca-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.