Indications and uses
temporarily relieves minor aches and pains due to: headache muscular aches backache minor pain of arthritis the common cold toothache premenstrual or menstrual cramps temporarily reduces fever
Acetaminophen USP 325 mg Tablets
- Manufacturer
- NuCare Pharmaceuticals,Inc.
- Effective date
- 2021-02-15
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 22:52:34
Label at a glance#
ProductACETAMINOPHEN 325 MG
Active ingredientACETAMINOPHEN
Label structure19 sections
Dosage and administration
do not take more than directed (see overdose warning) adults and children 12 years and over take 2 tablets every 4-6 hours while symptoms last, not more than 12 tablets in 24 hours children 6 to 11 years take 1 tablet every 4-6 hours while symptoms last, not more than 5 tablets in 24 hours children under 6 years do not use
Storage and handling
store at 15° to 30°C (59° to 86°F)
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, 325 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 or menstrual cramps
- temporarily reduces fever
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if
- adult takes more than 4,000 mg in 24 hours, which is the maximum daily amount
- child takes more than 5 tablets in 24 hours, which is the maximum daily amount
- taken with other drugs containing acetaminophen
- adult has 3 or more alcoholic drinks 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 the user has liver disease
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if the user is 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 in adults
- pain gets worse or lasts more than 5 days in children
- 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 and children 12 years and over | take 2 tablets every 4-6 hours while symptoms last, not more than 12 tablets in 24 hours |
| children 6 to 11 years | take 1 tablet every 4-6 hours while symptoms last, not more than 5 tablets in 24 hours |
| children under 6 years | do not use |
Other information
- store at 15° to 30°C (59° to 86°F)
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
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA-Initiated Inactive NDC Indexing#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 69618-010-01 | EA - Each | 69618-010 | e4afc635-7f91-4104-9fae-ea9ec25546cd | 1 | 2016-01-13 |
| 69618-010-10 | EA - Each | 69618-010 | c4fcdc23-5064-4fc1-82e0-bc730c667095 | 1 | 2016-01-13 |
Products#
Every source-derived product name is available through these pages.
- ACETAMINOPHEN 325 MG
- ACETAMINOPHEN
- STARCH, PREGELATINIZED CORN
- SODIUM STARCH GLYCOLATE TYPE A POTATO
- STEARIC ACID
- POVIDONE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 68071-4166 | 68071-4166-2, 68071-4166-3, 68071-4166-5, 68071-4166-4, 68071-4166-8 |
| 69618-010 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| STARCH, PREGELATINIZED CORN | O8232NY3SJ | IACT |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | 5856J3G2A2 | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| POVIDONE | FZ989GH94E | 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 |
|---|---|---|---|---|---|---|
| ACETAMINOPHEN 325 MG | ACETAMINOPHEN | Reliable 1 Laboratories LLC | 25626b46-78f8-7226-e054-00144ff8d46c | 2025-01-15 | Warnings | 69618-010 |
| 1a180cf7-e3df-a675-e063-6294a90abdbc | 5f11cb62-9eec-5ba9-e053-2a91aa0aa4e5 | 2024-06-04 | Warnings | 5f11cb62-9eec-5ba9-e053-2a91aa0aa4e5 |