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
ACETAMINOPHEN 500 MG TABLET
- Manufacturer
- A-S Medication Solutions
- Effective date
- 2026-05-12
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-01 01:57:02
Label at a glance#
ProductACETAMINOPHEN 500 MG
Active ingredientACETAMINOPHEN
Label structure20 sections
Dosage and administration
do not take more than directed (see overdose warning) adults & children 12 years and over: take 1 tablet every 3-4 hours or 2 tablets every 6 hours while symptoms last do not take more than 8 tablets in 24 hours children under 12 years: do not use
Storage and handling
store at 15º to 30ºC (59º to 86ºF)
Contacts and useful links#
Websitewww.reliable1labs.com
www.reliable1labs.com
www.reliable1labs.comLabel contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
Active ingredient (in each tablet)
Acetaminophen USP, 500 mg
Purpose
Pain reliever/fever reducer
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
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- more than 4,000 mg of acetaminophen in 24 hours which is the maximum daily amount
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
OTHER SAFETY INFORMATION
Allergy alert: 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.
OTC - DO NOT USE SECTION
Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
OTC - ASK DOCTOR SECTION
Ask a doctor before use if you have liver disease
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin
OTC - STOP USE SECTION
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.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.
Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. 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 & children 12 years and over:
- take 1 tablet every 3-4 hours or 2 tablets every 6 hours while symptoms last
- do not take more than 8 tablets in 24 hours
children under 12 years: do not use
Other information
- store at 15º to 30ºC (59º to 86ºF)
Inactive ingredients
povidone, pregelatinized corn starch, sodium starch glycolate, stearic acid
Questions or comments?
call 516-341-0666, 8:30 am - 4:30 pm ET, Monday - Friday
SPL UNCLASSIFIED SECTION
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
SPL UNCLASSIFIED SECTION
*Reliable 1 Laboratories LLC is not affiliated with the owner of the trademark TYLENOL®.
Distributed by: Reliable 1 Laboratories LLC, Valley Stream, NY 11580
HOW SUPPLIED
Product: 50090-7960
NDC: 50090-7960-2 100 TABLET in a BOTTLE, PLASTIC
ACETAMINOPHEN
DailyMed RxNorm Mappings#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50090-7960-2 | ACETAMINOPHEN 500 MG | 100 in 1 BOTTLE, PLASTIC | TABLET | 100 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 69618-011-01 | EA - Each | 69618-011 | 2d58ebc4-ee99-4bbc-8262-a7795e99fb38 | 1 | 2016-01-13 |
| 69618-011-10 | EA - Each | 69618-011 | 82753e1b-afa7-47c0-8df1-455476744709 | 1 | 2016-01-13 |
Products#
Every source-derived product name is available through these pages.
- ACETAMINOPHEN 500 MG
- ACETAMINOPHEN
- SODIUM STARCH GLYCOLATE TYPE A POTATO
- POVIDONE
- ZEA MAYS (CORN) STARCH
- STEARIC ACID
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 50090-7960 | 50090-7960-2 |
| 69618-011 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | 5856J3G2A2 | IACT |
| POVIDONE | FZ989GH94E | IACT |
| ZEA MAYS (CORN) STARCH | O8232NY3SJ | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
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 |
|---|---|---|---|---|---|---|
| ACETAMINOPHEN 500 MG | ACETAMINOPHEN | A-S Medication Solutions | c445c6bb-69a8-492e-b100-ce942707f203 | 2026-05-12 | Warnings | 50090-7960-2 50090-7960 50090796002 786e7294-9a0d-4243-9951-5863fd1cb75f c445c6bb-69a8-492e-b100-ce942707f203 |
| ACETAMINOPHEN 500 MG | ACETAMINOPHEN | Reliable 1 Laboratories LLC | 2651bf11-4d66-43ba-e054-00144ff88e88 | 2025-01-15 | Warnings | 69618-011 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.