Active Ingredients And Purpose
OTC - ACTIVE INGREDIENT SECTION
Active ingredient (in each tablet) Acetaminophen 325 mg
OTC - PURPOSE SECTION
Purpose Pain reliever/fever reducer
Active ingredient (in each tablet) Acetaminophen 325 mg
Purpose Pain reliever/fever reducer
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 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.
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
If pregnant or breast-feeding, ask a health professional before use.
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
Inactive ingredients povidone, pregelatinized starch, sodium starch glycolate*, stearic acid *may contain this ingredient
| 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 |
Active ingredient (in each tablet) Acetaminophen 325 mg
Purpose Pain reliever/fever reducer
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 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.
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
Ask a doctor before use if the user has liver disease
Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin
Stop use and ask a doctor if pain gets worse or lasts more than 10 days in adults pain gets worse or lasts more then 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.
If pregnant or breast-feeding, ask a health professional before use.
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.
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
SODIUM FREE store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F) use by expiration date on package
Inactive ingredients povidone, pregelatinized starch, sodium starch glycolate*, stearic acid *may contain this ingredient
Questions or comments? call 1-877-290-4008 Manufactured by: Time-Cap Labs, Inc., 7 Michael Avenue, Farmingdale, NY 11735 340R 1022
Official SPL XML cached by FDA.report · DailyMed PDF
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 10 | 2024-08-19 | full-release | 2026-06-01 00:17:52 |
| Folder | File | Date |
|---|---|---|
| otc | d48fadc8-c402-4ecd-b8af-c1ea069eac71.xml | 2025-11-21 |
| otc | 683ba71d-7575-4233-9b0f-b2f326484876.xml | 2024-08-28 |
| otc | 224b3b3d-1dc4-457c-b6a8-6ee82498daf6.xml | 2023-01-05 |
| otc | acetaminophen-tabs-325-mg-8397-1.jpg | 2022-12-01 |
| otc | acetaminophen-tabs-325-mg-8397-2.jpg | 2022-12-01 |
| otc | cc2a4b22-9fcd-4123-b7ad-859420d078dc.xml | 2022-12-01 |
| otc | bc9cde97-3cc8-4ba2-a755-8fda539aa2f5.xml | 2021-10-29 |
| otc | 0f1f5b69-942e-4e15-bc7b-bfc6107773ad.xml | 2021-05-11 |
| otc | acetaminophen-tablets-325mg---8397--time-cap-1.jpg | 2021-05-11 |
| otc | acetaminophen-tablets-325mg---8397--time-cap-2.jpg | 2021-05-11 |