Indications and uses
for the temporary relief of 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
Acetaminophen 500 mg Tablet
- Manufacturer
- Medsouce Pharmaceuticals | Medsource Pharmaceuticals
- Effective date
- 2020-10-05
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 23:31:03
Label at a glance#
ProductAcetaminophen PAIN RELIEVER,FEVER REDUCER 500 mg
Active ingredientACETAMINOPHEN
Label structure9 sections
Dosage and administration
Do not take more than directed (see overdose warning) Adults and children 12 years and over: take 2 tablets every 6 hours while symptoms last do not take more than 6 tablets in 24 hours unless directed by a doctor do not take for more than 10 days unless directed by a doctor. Children under 12 years: ask a doctor.
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredient (in each tablet)
Acetaminophen 500 mg
Purposes
Pain reliever/fever reducer
Uses
- for the temporary relief of 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
Warnings
Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 6 tablets (3,000 mg) in 24 hours. Severe liver damage may occur if you take
- more than 4,000 mg of acetaminophen in 24 hours
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
Do not use
- with any other drug containing acetaminophen (prescription or non prescription). 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
Ask a doctor before use if you have
liver disease.
Ask a doctor or pharmacist before use if you are
taking the blood thinning drug warfarin.
Stop use and ask a doctor if
- 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.
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children.
Overdose Warning: Taking more than the recommended dose (overdose) may cause liver damage. In the case of 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.
Directions
Do not take more than directed (see overdose warning)
Adults and children 12 years and over:
- take 2 tablets every 6 hours while symptoms last
- do not take more than 6 tablets in 24 hours unless directed by a doctor
- do not take for more than 10 days unless directed by a doctor.
Children under 12 years: ask a doctor.
Other information
- Do not use if imprinted safety seal under cap is broken or missing
- Store at room temperature
Inactive ingredients
Povidone, Pregelatinized Starch, Sodium Starch Glycolate, Stearic Acid.
Questions?
If you have any questions or comments, or to report an adverse event, please contact (800) 795-9775.
Principal Display Panel
DailyMed RxNorm Mappings#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 45865-136-30 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-b195-d83d-e063-dadaa90ab31f | Acetaminophen 500 mg Tablet |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 45865-136-30 | AcetaminophenPAIN RELIEVER,FEVER REDUCER 500 mg | 30 in 1 BOTTLE, PLASTIC | TABLET | 30 | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 51645-706-01 | EA - Each | 51645-706 | 9d69e3fa-cc3b-4b62-a473-63c1e4b8d089 | 1 | 2022-10-06 |
| 51645-706-10 | EA - Each | 51645-706 | 1ecd9f01-bdc1-4496-908c-9774c760dfd9 | 1 | 2021-11-09 |
Products#
Every source-derived product name is available through these pages.
- Acetaminophen PAIN RELIEVER,FEVER REDUCER 500 mg
- Acetaminophen
- POVIDONE
- STARCH, CORN
- SODIUM STARCH GLYCOLATE TYPE A CORN
- STEARIC ACID
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 45865-136 | 45865-136-30 |
| 51645-706 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| POVIDONE | FZ989GH94E | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| SODIUM STARCH GLYCOLATE TYPE A CORN | AG9B65PV6B | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| b0f4df02-b66b-c914-e053-2995a90a85db | b0f48418-4fc7-beda-e053-2a95a90abe00 | 2020-10-05 | Warnings | b0f4df02-b66b-c914-e053-2995a90a85db b0f48418-4fc7-beda-e053-2a95a90abe00 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.