Active Ingredients And Purpose
OTC - ACTIVE INGREDIENT SECTION
Active ingredient (in each tablet) Acetaminophen 500 mg
OTC - PURPOSE SECTION
Purpose Pain reliever/fever reducer
Active ingredient (in each tablet) Acetaminophen 500 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. Severe liver damage may occur if you have: more than 8 tablets in 24 hours, which is the maximum daily amount 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 redding *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 pregnant or breast-feeding , ask a health professional before use.
Overdose warning: Taking more than the recommended 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.
Directions do not take more than directed (see overdose warning) adults and children 12 years and over take 2 tablets (1,000 mg) every 6 hours while symptoms last do not take more than 6 tablets (3,000 ng) 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 do not use this adult extra strength product in children under 12 years of age; this will provide more than the recommended dose (overdose) of acetaminophen and may cause liver damage
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 povidone, pregelatinized starch, sodium starch glycolate*, stearic acid *may contain this ingredient
| Name | UNII | Kind |
|---|---|---|
| POVIDONE | FZ989GH94E | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | 5856J3G2A2 | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
Active ingredient (in each tablet) Acetaminophen 500 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. Severe liver damage may occur if you have: more than 8 tablets in 24 hours, which is the maximum daily amount 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 redding *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 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: Taking more than the recommended 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.
Directions do not take more than directed (see overdose warning) adults and children 12 years and over take 2 tablets (1,000 mg) every 6 hours while symptoms last do not take more than 6 tablets (3,000 ng) 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 do not use this adult extra strength product in children under 12 years of age; this will provide more than the recommended dose (overdose) of acetaminophen and may cause liver damage
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 povidone, pregelatinized starch, sodium starch glycolate*, stearic acid *may contain this ingredient
Official SPL XML cached by FDA.report · DailyMed PDF
| Folder | File | Date |
|---|---|---|
| otc | 97f16642-ea3a-f5da-e053-2995a90aaa08.xml | 2019-11-23 |
| otc | 252R 100 CT LABEL.jpg | 2019-10-08 |
| otc | 9455f5d1-5854-1b26-e053-2995a90aa310.xml | 2019-10-08 |