ACETAMINOPHEN
- Manufacturer
- NCS HealthCare of KY, LLC dba Vangard Labs
- Effective date
- 2024-08-13
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 14
- Source
- monthly-update
- Hydrated at
- 2026-06-03 17:40:18
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Active ingredient (in each caplet)
Acetaminophen 500 mg
OTC - PURPOSE SECTION
Purpose
Pain reliever/fever reducer
INDICATIONS & USAGE SECTION
Uses
- temporarily relieves minor aches and pains due to:
• headache
• the common cold
• backache
• minor pain of arthritis
• toothache
• muscular aches
• premenstrual and menstrual cramps
- temporarily reduces fever
WARNINGS SECTION
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
- with other drugs containing acetaminophen
- 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 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 using and ask a doctor if
- pain gets worse or lasts more than 10 days
- fever gets worse or last 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 (1-800-222-1222) right away. 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 caplets every 6 hours while symptoms last
- do not take more than 6 caplets in 24 hours, unless directed by a doctor
- do not use for more than 10 days unless directed by a doctor
children under 12 years
ask a doctor
SPL UNCLASSIFIED SECTION
Other information
- SODIUM FREE
- store between 20-25°C (68-77°F) excursions permitted between 15°-30°C (59°-86°F)
- use by expiration date on package
INACTIVE INGREDIENT SECTION
Inactive ingredients hypromellose, mineral oil, povidone, pregelatinized starch, sodium starch glycloate*, stearic acid, titanium dioxide
*may contain this ingredient
Questions or comments? Call 1-877-290-4008
OTC - QUESTIONS SECTION
Manufactured by:
Time-Cap Labs, Inc
7 Michael Avenue
Farmingdale, NY 11735
341R 0922
PRINCIPAL DISPLAY PANEL - BINGO CARD
PRINCIPAL DISPLAY PANEL - UNIT DOSE
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Data code | Code 128 | 4948334150 | acetaminophen-caplets-8409-1.jpg, acetaminophen-caplets-8409-2.jpg |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 49483-341-01 | EA - Each | 49483-341 | 235679f0-0eaa-47b9-899d-635267686003 | 1 | 2016-12-07 |
| 49483-341-10 | EA - Each | 49483-341 | 71d67bca-8711-4a54-a736-537e8c9e887e | 1 | 2022-02-07 |
| 49483-341-50 | EA - Each | 49483-341 | 2a7fd6e7-9368-4aee-9196-b0ae222c383f | 1 | 2021-06-02 |
Products#
Every source-derived product name is available through these pages.
- ACETAMINOPHEN Extra Strength
- ACETAMINOPHEN
- HYPROMELLOSES
- MINERAL OIL
- POVIDONE
- STARCH, CORN
- STEARIC ACID
- TITANIUM DIOXIDE
- SODIUM STARCH GLYCOLATE TYPE A CORN
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0615-8409 | 0615-8409-39, 0615-8409-30, 0615-8409-05 |
| 49483-341 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| HYPROMELLOSES | 3NXW29V3WO | IACT |
| MINERAL OIL | T5L8T28FGP | IACT |
| POVIDONE | FZ989GH94E | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| SODIUM STARCH GLYCOLATE TYPE A CORN | AG9B65PV6B | 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 Extra Strength | ACETAMINOPHEN | TIME CAP LABS INC | fd24d0e0-4f36-42d3-9149-2fb957690305 | 2025-06-25 | Warnings | 49483-341 |
| e57e46f5-443b-469b-b046-aedeb8348034 | 7fae4caf-a8aa-442e-97ee-0465577bdb87 | 2024-08-13 | Warnings | e57e46f5-443b-469b-b046-aedeb8348034 7fae4caf-a8aa-442e-97ee-0465577bdb87 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.

