Indications and uses
Temporary relieves minor aches and pains due to: headache muscular aches backache minor pain of arthritis the common cold toothache temporarily reduces fever premenstrual and menstrual cramps
Temporary relieves minor aches and pains due to: headache muscular aches backache minor pain of arthritis the common cold toothache temporarily reduces fever premenstrual and menstrual cramps
do not use more than directed (see overdose warning) Adults and children 12 years of age and older: 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 more than 10 days unless directed by a doctor. Children under 12 years of age: Do not use this extra strength product. This will provide more than the recommended dose (overdose) and ...
(in each tablet)
Acetaminophen 500mg
Pain reliever/fever reducer
Temporary relieves minor aches and pains due to:
Liver warning:This product contains acetaminophen. The maximum daily dose of this product is 6 caplets (3000 mg) in 24 hours. Severe liver damage may occur if you take
Allergy alert:Acetaminophen may cause severe skin reactions. Symptoms may include:
If a skin reaction occurs; stop use and seek medical help right away.
Do not use
Ask a doctor before use if you have
Ask a doctor or pharmacist before use if you are
Stop use and ask a doctor if
These could be signs of a serious condition.
ask a health professional before use
Overdose warning:Taking more than the reccomended dose (overdose) may cause liver damage. 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.
Adults and children 12 years of age and older:
Children under 12 years of age: Do not use this extra strength product. This will provide more than the recommended dose (overdose) and could cause serious health problems.
Colloidal silicon dioxide, pregelatinized starch, povidone (pvp k-30), croscarmellose sodium, potassium sorbate, stearic acid
Call 619-600-5632 Monday through Friday 9AM-5PM EST
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 69729-107-40 | 2025-07-29 | C162847 | 48780-1 | d6a99b39-6168-a426-e053-dadaa90af4c2 | Temp X Caplets |
| 69729-107-40 | 2025-03-19 | C162847 | 48780-1 | d6a99b39-6168-a426-e053-dadaa90af4c2 | Temp X Caplets |
| 69729-107-40 | 2025-01-30 | C162847 | 48780-1 | d6a99b39-6168-a426-e053-dadaa90af4c2 | Temp X Caplets |
| 69729-107-40 | 2023-12-15 | C162847 | 48780-1 | d6a99b39-6168-a426-e053-dadaa90af4c2 | Temp X Caplets |
| 69729-107-40 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-6168-a426-e053-dadaa90af4c2 | Temp X Caplets |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69729-107-40 | Extra Strenghth Acetaminophen | 1 in 1 CARTON | TABLET | 1 | 5 | |
| 69729-107-40 | Extra Strenghth Acetaminophen | 40 in 1 BOTTLE | TABLET | 40 | 5 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 69729-107 | 69729-107-40 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| STARCH, PREGELATINIZED CORN | O8232NY3SJ | IACT |
| POVIDONE K30 | U725QWY32X | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| POTASSIUM SORBATE | 1VPU26JZZ4 | IACT |
| CROSCARMELLOSE SODIUM | M28OL1HH48 | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
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 |
|---|---|---|---|---|---|---|
| 30b6aac4-6c66-45db-e063-6394a90aa5c5 | ae6dae28-6f4f-16d1-e053-2995a90adbab | 2025-03-19 | Warnings | 30b6aac4-6c66-45db-e063-6394a90aa5c5 ae6dae28-6f4f-16d1-e053-2995a90adbab |
Adverse event summaries are temporarily unavailable. Other product information remains available.