Indications and uses
temporarily relieves minor aches and pains due to: headache the common cold backache toothache minor pain from arthritis muscular aches premenstrual and menstrual cramps temporarily reduces fever
Pain Reliever
- Manufacturer
- Sam's West Inc | LNK International, Inc.
- Effective date
- 2026-08-19
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- daily-update
- Hydrated at
- 2026-08-21 02:00:59
Label at a glance#
ProductAcetaminophen
Active ingredientACETAMINOPHEN
Label structure9 sections
Dosage and administration
do not take more than directed 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
Storage and handling
store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) use by expiration date on package
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredient (in each caplet)
Acetaminophen 500 mg
Purpose
Pain reliever/fever reducer
Uses
- temporarily relieves minor aches and pains due to:
- headache
- the common cold
- backache
- toothache
- minor pain from arthritis
- muscular aches
- 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
- 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.
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.
Ask a doctor before use if you have
liver disease.
Ask a doctor or pharmacist before use if you are
taking the blood thinning drug warfarin.
Stop use and ask a doctor if
- pain gets worse or lasts more than 10 days
- redness or swelling is present
- fever gets worse or lasts more than 3 days
- any new symptoms appear
If pregnant or breast-feeding,
ask a health professional before use.
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away. Prompt 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
- 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 information
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- use by expiration date on package
Inactive ingredients
castor oil, hypromellose, povidone, sodium starch glycolate, starch, stearic acid
Questions or comments?
1-800-426-9391
Principal Display Panel
COMPARE TO EXTRA STRENGTH
TYLENOL® CAPLETS ACTIVE INGREDIENT*
M
Member's
Mark™
NDC 68196-031-06
EXTRA STRENGTH
Acetaminophen
500 mg CAPLETS
Pain Reliever/Fever Reducer
600 CAPLETS**
(**CAPSULE SHAPED TABLETS)
ACTUAL SIZE
FOR ADULTS
DailyMed Product Concepts#
Products#
Every source-derived product name is available through these pages.
- Acetaminophen
- CASTOR OIL
- HYPROMELLOSE, UNSPECIFIED
- POVIDONE, UNSPECIFIED
- SODIUM STARCH GLYCOLATE TYPE A POTATO
- STARCH, CORN
- STEARIC ACID
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 68196-031 | 68196-031-06 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| CASTOR OIL | D5340Y2I9G | IACT |
| HYPROMELLOSE, UNSPECIFIED | 3NXW29V3WO | IACT |
| POVIDONE, UNSPECIFIED | FZ989GH94E | IACT |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | 5856J3G2A2 | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 2 | 2025-10-23 | full-release | 2026-06-01 01:18:13 |
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 | Sam's West Inc | 1098d0e7-8202-4018-a2d2-b0c80ee58b56 | 2026-08-19 | Warnings | 68196-031-06 68196-031 68196003106 6a06c9ee-2b77-4501-ac01-900cd595d597 1098d0e7-8202-4018-a2d2-b0c80ee58b56 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.