Indications and uses
■ temporarily relieves minor aches and pains due to: ■ headache ■ muscular aches ■ backache ■ minor pain of arthritis ■ the common cold ■ toothache ■ premenstrual and menstrual cramps ■ temporarily reduces fever
■ temporarily relieves minor aches and pains due to: ■ headache ■ muscular aches ■ backache ■ minor pain of arthritis ■ the common cold ■ toothache ■ premenstrual and menstrual cramps ■ temporarily reduces fever
■ do not take more than directed (see overdose warning) adults and children 12 years and over ■ take 2 gelcaps every 6 hours while symptoms last ■ do not take more than 6 gelcaps in 24 hours, unless directed by a doctor ■ do not take more than 10 days unless directed by a doctor children under 12 years ■ ask a doctor
■ store at 20°-25°C (68°-77°F). See USP Controlled Room Temperature ■ avoid high humidity ■ see end panel for expiration date and lot number
Acetaminophen USP, 500 mg
Pain reliever/fever reducer
■ temporarily relieves minor aches and pains due to:
■ headache
■ muscular aches
■ backache
■ minor pain of arthritis
■ the common cold
■ toothache
■ premenstrual and menstrual cramps
■ temporarily reduces fever
This product contains acetaminophen. Severe liver damage may occur if you take:
acetaminophen may cause severe skin reactions. Symptoms may include:
■ skin reddening
■ blisters
■ rash
If a skin reaction occurs, stop use and seek medical help right away.
■ with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist
■ if you are allergic to acetaminophen or any of the inactive ingredients in this product
liver disease.
taking the blood thinning drug warfarin.
■ pain gets worse or lasts more than 10 days
■ fever gets worse or lasts more than 3 days
■ new symptoms occur
■ redness or swelling is present
These could be signs of a serious condition.
ask a health professional before use.
Keep out of the reach of children.
In case of accidental overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
■ do not take more than directed (see overdose warning)
adults and children 12 years and over
■ take 2 gelcaps every 6 hours while symptoms last
■ do not take more than 6 gelcaps in 24 hours, unless directed by a doctor
■ do not take more than 10 days unless directed by a doctor
children under 12 years
■ ask a doctor
■ store at 20°-25°C (68°-77°F). See USP Controlled Room Temperature
■ avoid high humidity
■ see end panel for expiration date and lot number
ammonium hydroxide, black iron oxide, colloidal silicon dioxide, croscarmellose sodium, D&C red #33, FD&C blue #1, FD&C red #40, FD&C yellow #6, gelatin, hydroxypropyl cellulose, hydroxypropyl methyl cellulose, hypromellose, iron oxide red, isopropyl alcohol, n-butyl alcohol, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, shellac glaze, stearic acid, titanium dioxide, yellow iron oxide
call 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST.
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69842-295-05 | Acetaminophen | 50 in 1 BOTTLE | TABLET | 50 | 9 | |
| 69842-295-10 | Acetaminophen | 100 in 1 BOTTLE | TABLET | 100 | 9 | |
| 69842-295-15 | Acetaminophen | 150 in 1 BOTTLE | TABLET | 150 | 9 | |
| 69842-295-21 | Acetaminophen | 225 in 1 BOTTLE | TABLET | 225 | 9 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 69842-295 | 69842-295-05, 69842-295-10, 69842-295-15, 69842-295-21 |
Every source-derived ingredient row is available through these pages.
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 8 | 2025-12-11 | legacy-cache | 2026-10-21 17:51:32 |
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 |
|---|---|---|---|---|---|---|
| Acetaminophen | ACETAMINOPHEN | CVS PHARMACY, INC | b1307d52-10e6-46e1-e053-2995a90a03b6 | 2025-12-19 | Warnings | 69842-295-10 69842-295-15 69842-295-05 69842-295-21 69842-295 69842029510 69842029505 69842029521 69842029515 46546de7-075e-b09c-e063-6294a90ae4b3 b1307d52-10e6-46e1-e053-2995a90a03b6 |
Adverse event summaries are temporarily unavailable. Other product information remains available.