acetaminophen
- Manufacturer
- TARGET CORPORATION | TIME CAP LABORATORIES, INC | TIME CAP LABORATORIES, INC.
- Effective date
- 2025-09-29
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- monthly-update
- Hydrated at
- 2026-06-03 17:52:10
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
Drug Facts
Drug Facts
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:
-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. 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 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.
OVERDOSAGE SECTION
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 caplets every 6 hours while symptoms last
-do not take more than 6 caplets 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 SAFETY INFORMATION
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 glycolate* stearic acid, titanium dioxide
*may contain this ingredient
OTC - QUESTIONS SECTION
Questions or comments? Call 1-800-910-6874
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed RxNorm Mappings#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 11673-838-01 | acetaminophen | 100 in 1 BOTTLE | TABLET, COATED | 100 | 4 | |
| 11673-838-05 | acetaminophen | 50 in 1 BOTTLE | TABLET, COATED | 50 | 4 | |
| 11673-838-10 | acetaminophen | 2 in 1 CARTON | TABLET, COATED | 2 | 4 | |
| 11673-838-26 | acetaminophen | 225 in 1 BOTTLE | TABLET, COATED | 225 | 4 | |
| 11673-838-50 | acetaminophen | 500 in 1 BOTTLE | TABLET, COATED | 500 | 4 |
Products#
Every source-derived product name is available through these pages.
- acetaminophen
- HYPROMELLOSES
- POVIDONE, UNSPECIFIED
- SODIUM STARCH GLYCOLATE TYPE A CORN
- STEARIC ACID
- TITANIUM DIOXIDE
- MINERAL OIL
- STARCH, CORN
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 11673-838 | 11673-838-01, 11673-838-05, 11673-838-50, 11673-838-26, 11673-838-10 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| HYPROMELLOSES | 3NXW29V3WO | IACT |
| POVIDONE, UNSPECIFIED | FZ989GH94E | IACT |
| SODIUM STARCH GLYCOLATE TYPE A CORN | AG9B65PV6B | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| MINERAL OIL | T5L8T28FGP | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 3 | 2024-08-27 | full-release | 2026-06-01 00:22:06 |
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 | TARGET CORPORATION | 8ed1d1f5-fe4a-5fd8-e053-2a95a90a90fb | 2025-09-29 | Warnings | 11673-838-01 11673-838-10 11673-838-26 11673-838-50 11673-838-05 11673-838 11673083826 11673083805 11673083810 11673083801 11673083850 3feb273f-9713-576d-e063-6294a90aaad4 8ed1d1f5-fe4a-5fd8-e053-2a95a90a90fb |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.








