Bayer Back & Body - Extra Strength
0c77c484-6caf-12ca-e054-00144ff88e88
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Drug Facts
Medication Information
Description
Drug Facts
Uses
for the temporary relief of
- backache pain
- muscle aches and pains
- minor aches and pains of arthritis
Section 50565-1
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Section 50568-5
Ask a doctor or pharmacist before use if you are taking a prescription drug for
- gout
- diabetes
- arthritis
Section 51945-4
Section 53413-1
Questions or comments? 1-800-331-4536 (Mon-Fri 9AM - 5PM EST)
Section 53414-9
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.
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
- 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
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: consult a doctor
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
Drug Facts
Drug Facts
Other Information
- save carton for full directions and warnings
- store at room temperature. Avoid excessive heat above 40°C (104°F).
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
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 are taking a diuretic
- you have asthma
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:
- 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
Active Ingredients (in Each Caplet)
| Active ingredients (in each caplet) | Purpose |
| Aspirin 500 mg (NSAID)
nonsteroidal anti-inflammatory drug
|
Pain reliever |
| Caffeine 32.5 mg | Pain reliever aid |
Structured Label Content
Uses
for the temporary relief of
- backache pain
- muscle aches and pains
- minor aches and pains of arthritis
Section 50565-1 (50565-1)
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Section 50568-5 (50568-5)
Ask a doctor or pharmacist before use if you are taking a prescription drug for
- gout
- diabetes
- arthritis
Section 51945-4 (51945-4)
Section 53413-1 (53413-1)
Questions or comments? 1-800-331-4536 (Mon-Fri 9AM - 5PM EST)
Section 53414-9 (53414-9)
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.
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
- 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
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: consult a doctor
Do Not Use (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
Drug Facts
Drug Facts
Other Information
- save carton for full directions and warnings
- store at room temperature. Avoid excessive heat above 40°C (104°F).
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
Ask A Doctor Before Use If (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 are taking a diuretic
- you have asthma
Stop Use and Ask A Doctor If (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:
- 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
Active Ingredients (in Each Caplet) (Active ingredients (in each caplet))
| Active ingredients (in each caplet) | Purpose |
| Aspirin 500 mg (NSAID)
nonsteroidal anti-inflammatory drug
|
Pain reliever |
| Caffeine 32.5 mg | Pain reliever aid |
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
Back to search View SPL set listing Open on DailyMed ↗
Source: dailymed · Ingested: 2026-02-15T12:05:52.991945 · Updated: 2026-03-14T23:08:17.487612