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 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. 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.
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 6 hours while symptoms last do not take more than 6 tablets in 24 hours, unless directed by a doctor do not use for more than 10 days unless directed by a doctor children under 12 years: ask a doctor
Inactive ingredients carnauba wax, FD&C red #40 aluminum lake, hypromellose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate*, stearic acid, sucralose, titanium dioxide *may contain this ingredient
Questions or comments? Call 1-800-910-6874
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 11673-342-01 | ACETAMINOPHEN | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | 3 | |
| 11673-342-26 | ACETAMINOPHEN | 225 in 1 BOTTLE | TABLET, FILM COATED | 225 | 3 | |
| 11673-342-42 | ACETAMINOPHEN | 24 in 1 BOTTLE | TABLET, FILM COATED | 24 | 3 |
| Product NDC | Package NDC |
|---|---|
| 11673-342 | 11673-342-42, 11673-342-01, 11673-342-26 |
| Name | UNII | Kind |
|---|---|---|
| POLYETHYLENE GLYCOL 8000 | Q662QK8M3B | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| HYPROMELLOSES | 3NXW29V3WO | IACT |
| POLYETHYLENE GLYCOL 400 | B697894SGQ | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | 5856J3G2A2 | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| CARNAUBA WAX | R12CBM0EIZ | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| POVIDONE | FZ989GH94E | IACT |
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 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. if you are allergic to acetaminophen or any of the inactive ingredients in this product
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: 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 6 hours while symptoms last do not take more than 6 tablets in 24 hours, unless directed by a doctor do not use for more than 10 days unless directed by a doctor children under 12 years: ask a doctor
Other information 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 carnauba wax, FD&C red #40 aluminum lake, hypromellose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate*, stearic acid, sucralose, titanium dioxide *may contain this ingredient
Questions or comments? Call 1-800-910-6874