ACETAMINOPHEN
- Manufacturer
- NCS HealthCare of KY, LLC dba Vangard Labs
- Effective date
- 2024-06-12
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 11
- Source
- full-release
- Hydrated at
- 2026-06-01 01:17:07
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Active ingredient (in each tablet)
Acetaminophen 325 mg
OTC - PURPOSE SECTION
Purpose
Pain reliever/fever reducer
INDICATIONS & USAGE SECTION
Uses
- temporarily relieves minor aches and pains due to:
- the common cold
- headache
- backache
- minor pain of arthritis
- toothache
- muscular aches
- premenstrual and menstrual cramps
- temporarily reduces fever
WARNINGS SECTION
Warnings
Liver Warning: This product contains acetaminophen. The maximum daily dose of this product is 10 tablets (3,250 mg) in 24 hours for adults or 5 tablets (1,625 mg) in 24 hours for children. Severe liver damage may occur if:
- adult takes more than 4,000 mg of acetaminophen in 24 hours.
- child takes more than 5 doses in 24 hours, which is the maximum daily amount
- taken with other drugs containing acetaminophen
- adult has 3 or more alcoholic drinks every day while using this product
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.
- if you are allergic to acetaminophen or any of the inactive ingredients in this product
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 under 12 years
- 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: In 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.
DOSAGE & ADMINISTRATION SECTION
Directions
- do not take more than directed
See overdose warning
adults and children 12 years and over
- take 2 tablets every 4 to 6 hours while symptoms last
- do not take more than 10 tablets in 24 hours, unless directed by a doctor
- do not use for more than 10 days unless directed by a doctor
children 6 years to under 12 years
- take 1 tablet every 4 to 6 hours while symptoms last
- do not take more than 5 tablets in 24 hours
- do not use for more than 5 days unless directed by a doctor
children under 6 years
ask a doctor
OTHER INFORMATION
Other information
- SODIUM FREE
- store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)
- use by expiration date on package
INACTIVE INGREDIENT SECTION
Inactive ingredients
povidone, pregelatinized starch, sodium starch glycolate*, stearic acid
*may contain this ingredient
SPL UNCLASSIFIED SECTION
Questions or comments? call 1-877-290-4008
Manufactured by: Time-Cap Labs, Inc.,
7 Michael Avenue, Farmingdale, NY 11735
340R 1022
PRINCIPAL DISPLAY PANEL
DailyMed RxNorm Mappings#
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0615-8398-67 | ACETAMINOPHEN | 60 in 1 BLISTER PACK | TABLET | 60 | 11 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 49483-340-01 | EA - Each | 49483-340 | 24193a13-9584-4d37-9512-ed41d3dd4b7c | 1 | 2016-12-07 |
| 49483-340-10 | EA - Each | 49483-340 | cd27a4fd-0234-4d68-9429-662a87a63222 | 1 | 2021-05-05 |
Products#
Every source-derived product name is available through these pages.
- ACETAMINOPHEN
- POVIDONE
- STARCH, CORN
- SODIUM STARCH GLYCOLATE TYPE A POTATO
- STEARIC ACID
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0615-8398 | 0615-8398-67 |
| 49483-340 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| POVIDONE | FZ989GH94E | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | 5856J3G2A2 | 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 | ACETAMINOPHEN | TIME CAP LABS INC | c193dbc0-cc80-4a7c-aa29-457a20edf835 | 2025-02-08 | Warnings | 49483-340 |
| 7a07f711-5ff9-4176-b752-7210792b55a8 | 3f2eadf9-9bb3-437e-972d-232828ca9d34 | 2024-06-12 | Warnings | 7a07f711-5ff9-4176-b752-7210792b55a8 3f2eadf9-9bb3-437e-972d-232828ca9d34 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
