Indications and uses
for the temporary relief of backache pain muscle aches and pains minor aches and pains of arthritis
for the temporary relief of backache pain muscle aches and pains minor aches and pains of arthritis
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
Drug Facts
for the temporary relief of
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
Ask a doctor or pharmacist before use if you are taking a prescription drug for
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.
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)
| Class | Version | Type | Effective |
|---|---|---|---|
| ASPIRIN Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20191108 |
| CAFFEINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0280-2150-01 | Bayer Back and BodyExtra Strength | 1 in 1 CARTON | TABLET | 1 | 7 | |
| 0280-2150-01 | Bayer Back and BodyExtra Strength | 6 in 1 BOTTLE, PLASTIC | TABLET | 6 | 7 | |
| 0280-2150-02 | Bayer Back and BodyExtra Strength | 200 in 1 BOTTLE, PLASTIC | TABLET | 200 | 7 | |
| 0280-2150-03 | Bayer Back and BodyExtra Strength | 250 in 1 BOTTLE | TABLET | 250 | 7 | |
| 0280-2150-10 | Bayer Back and BodyExtra Strength | 100 in 1 BOTTLE, PLASTIC | TABLET | 100 | 7 | |
| 0280-2150-10 | Bayer Back and BodyExtra Strength | 1 in 1 CARTON | TABLET | 1 | 7 | |
| 0280-2150-24 | Bayer Back and BodyExtra Strength | 24 in 1 BOTTLE, PLASTIC | TABLET | 24 | 7 | |
| 0280-2150-24 | Bayer Back and BodyExtra Strength | 1 in 1 CARTON | TABLET | 1 | 7 | |
| 0280-2150-50 | Bayer Back and BodyExtra Strength | 50 in 1 BOTTLE, PLASTIC | TABLET | 50 | 7 | |
| 0280-2150-50 | Bayer Back and BodyExtra Strength | 1 in 1 CARTON | TABLET | 1 | 7 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| ASPIRIN | ACTIVE INGREDIENT | R16CO5Y76E | 1 | |
| CAFFEINE | ACTIVE INGREDIENT | 3G6A5W338E | 1 | |
| ASPIRIN | ACTIVE MOIETY | R16CO5Y76E | 1 | |
| CAFFEINE | ACTIVE MOIETY | 3G6A5W338E | 1 | |
| ALUMINUM OXIDE | INACTIVE INGREDIENT | LMI26O6933 | 1 | |
| CARNAUBA WAX | INACTIVE INGREDIENT | R12CBM0EIZ | 1 | |
| D&C RED NO. 30 | INACTIVE INGREDIENT | 2S42T2808B | 1 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | 1 | |
| POWDERED CELLULOSE | INACTIVE INGREDIENT | SMD1X3XO9M | 1 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | 1 | |
| SHELLAC | INACTIVE INGREDIENT | 46N107B71O | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | 1 | |
| TRIACETIN | INACTIVE INGREDIENT | XHX3C3X673 | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 0280-2150 | 0280-2150-24, 0280-2150-50, 0280-2150-10, 0280-2150-02, 0280-2150-01, 0280-2150-03 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| STARCH, CORN | O8232NY3SJ | IACT |
| D&C RED NO. 30 | 2S42T2808B | IACT |
| ALUMINUM OXIDE | LMI26O6933 | IACT |
| D&C YELLOW NO. 10 | 35SW5USQ3G | IACT |
| HYPROMELLOSES | 3NXW29V3WO | IACT |
| POWDERED CELLULOSE | SMD1X3XO9M | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| SHELLAC | 46N107B71O | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| CARNAUBA WAX | R12CBM0EIZ | IACT |
| TRIACETIN | XHX3C3X673 | IACT |
| CAFFEINE | 3G6A5W338E | ACTIB |
| ASPIRIN | R16CO5Y76E | ACTIB |
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.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| POWDERED CELLULOSE | POWDERED CELLULOSE | SMD1X3XO9M | TABLET / ORAL | 1582 mg | ||
| CARNAUBA WAX | CARNAUBA WAX | R12CBM0EIZ | TABLET / ORAL | 167.8 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET / ORAL | 232 mg | ||
| POWDERED CELLULOSE | POWDERED CELLULOSE | SMD1X3XO9M | TABLET / ORAL | 1582 mg | ||
| ALUMINUM OXIDE | ALUMINUM OXIDE | LMI26O6933 | TABLET / ORAL | NA | ||
| ALUMINUM OXIDE | ALUMINUM OXIDE | LMI26O6933 | TABLET / ORAL | NA | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET / ORAL | 232 mg | ||
| TRIACETIN | TRIACETIN | XHX3C3X673 | TABLET / ORAL | 208 mg | ||
| D&C YELLOW NO. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | TABLET / ORAL | 80 mg | ||
| D&C RED NO. 30 | D&C RED NO. 30 | 2S42T2808B | TABLET / ORAL | 19 mg | ||
| D&C RED NO. 30 | D&C RED NO. 30 | 2S42T2808B | TABLET / ORAL | 19 mg | ||
| SHELLAC | SHELLAC | 46N107B71O | TABLET / ORAL | 112 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | TABLET / ORAL | 1127 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET / ORAL | 1116 mg | ||
| SHELLAC | SHELLAC | 46N107B71O | TABLET / ORAL | 112 mg | ||
| D&C YELLOW NO. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | TABLET / ORAL | 80 mg | ||
| SHELLAC | SHELLAC | 46N107B71O | TABLET / ORAL | 112 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | TABLET / ORAL | 1127 mg | ||
| TRIACETIN | TRIACETIN | XHX3C3X673 | TABLET / ORAL | 208 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | TABLET / ORAL | 1127 mg | ||
| POWDERED CELLULOSE | POWDERED CELLULOSE | SMD1X3XO9M | TABLET / ORAL | 1582 mg | ||
| POWDERED CELLULOSE | POWDERED CELLULOSE | SMD1X3XO9M | TABLET / ORAL | 1582 mg | ||
| ALUMINUM OXIDE | ALUMINUM OXIDE | LMI26O6933 | TABLET / ORAL | NA | ||
| TRIACETIN | TRIACETIN | XHX3C3X673 | TABLET / ORAL | 208 mg | ||
| SHELLAC | SHELLAC | 46N107B71O | TABLET / ORAL | 112 mg | ||
| POWDERED CELLULOSE | POWDERED CELLULOSE | SMD1X3XO9M | TABLET / ORAL | 1582 mg | ||
| TRIACETIN | TRIACETIN | XHX3C3X673 | TABLET / ORAL | 208 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET / ORAL | 232 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET / ORAL | 1116 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | TABLET / ORAL | 1127 mg | ||
| ALUMINUM OXIDE | ALUMINUM OXIDE | LMI26O6933 | TABLET / ORAL | NA | ||
| D&C RED NO. 30 | D&C RED NO. 30 | 2S42T2808B | TABLET / ORAL | 19 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET / ORAL | 1116 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET / ORAL | 1116 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | TABLET / ORAL | 1127 mg | ||
| SHELLAC | SHELLAC | 46N107B71O | TABLET / ORAL | 112 mg | ||
| CARNAUBA WAX | CARNAUBA WAX | R12CBM0EIZ | TABLET / ORAL | 167.8 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET / ORAL | 1116 mg | ||
| D&C RED NO. 30 | D&C RED NO. 30 | 2S42T2808B | TABLET / ORAL | 19 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | TABLET / ORAL | 1127 mg | ||
| CARNAUBA WAX | CARNAUBA WAX | R12CBM0EIZ | TABLET / ORAL | 167.8 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET / ORAL | 64 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET / ORAL | 232 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET / ORAL | 64 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET / ORAL | 232 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET / ORAL | 64 mg | ||
| POWDERED CELLULOSE | POWDERED CELLULOSE | SMD1X3XO9M | TABLET / ORAL | 1582 mg | ||
| TRIACETIN | TRIACETIN | XHX3C3X673 | TABLET / ORAL | 208 mg | ||
| D&C RED NO. 30 | D&C RED NO. 30 | 2S42T2808B | TABLET / ORAL | 19 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET / ORAL | 64 mg | ||
| CARNAUBA WAX | CARNAUBA WAX | R12CBM0EIZ | TABLET / ORAL | 167.8 mg | ||
| ALUMINUM OXIDE | ALUMINUM OXIDE | LMI26O6933 | TABLET / ORAL | NA | ||
| D&C YELLOW NO. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | TABLET / ORAL | 80 mg | ||
| ALUMINUM OXIDE | ALUMINUM OXIDE | LMI26O6933 | TABLET / ORAL | NA | ||
| D&C YELLOW NO. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | TABLET / ORAL | 80 mg | ||
| SHELLAC | SHELLAC | 46N107B71O | TABLET / ORAL | 112 mg | ||
| POWDERED CELLULOSE | POWDERED CELLULOSE | SMD1X3XO9M | TABLET / ORAL | 1582 mg | ||
| SHELLAC | SHELLAC | 46N107B71O | TABLET / ORAL | 112 mg | ||
| CARNAUBA WAX | CARNAUBA WAX | R12CBM0EIZ | TABLET / ORAL | 167.8 mg | ||
| ALUMINUM OXIDE | ALUMINUM OXIDE | LMI26O6933 | TABLET / ORAL | NA |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Bayer Back and Body Extra Strength | ASPIRIN,CAFFEINE | Bayer HealthCare LLC. | 0c77c484-6caf-12ca-e054-00144ff88e88 | 2025-04-10 | Warnings | 0280-2150-24 0280-2150-01 0280-2150-02 0280-2150-10 0280-2150-50 0280-2150-03 0280-2150 00280215003 00280215001 00280215024 00280215050 00280215002 00280215010 32715f4e-2d90-9bff-e063-6394a90a4aab 0c77c484-6caf-12ca-e054-00144ff88e88 |
Adverse event summaries are temporarily unavailable. Other product information remains available.