ACETAMINOPHEN- acetaminophen tablet
Aphena Pharma Solutions — Tennessee, LLC
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
(in each tablet)
Acetaminophen 325 mg
Pain Reliever / Fever Reducer
temporarily reduces fever and relieves minor aches and pains caused by
- common cold
- muscular aches
- minor pain of arthritis
- premenstrual and menstrual cramps
Liver warning: this product contains acetaminophen. Severe liver damage may occur if
- adult takes more than 12 tablets in 24 hours, which is the maximum daily amount
- child takes more than 5 tablets 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
do not use with any other drug containing acetaminophen (prescription or non prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
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
- adult’s pain gets worse or lasts more than 10 days
- child’s pain gets worse or lasts more than 5 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- any new symptoms appear
If pregnant or breast-feeding, ask a health professional before use.
Overdose warning:Taking more than the recommended dose may cause liver damage. In case of overdose contact Poisom Control Center right away. Quick medical attention is critical for adults as well as children even if you do not notice any signs of symptoms.
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.
|adults and children 12 years and over||2 tablets every 4 to 6 hours while symptoms last, not more than 10 tablets in 24 hours. Do not use more than 10 days unless directed by doctor|
|children 6 to 11 years||1 tablet every 4-6 hours while symptoms last, not more than 5 tablets in 24 hours. Do not use more than 5 days unless directed by doctor|
|children under 6 years||ask a doctor|
store at 15-30 °C (59-86 °F)
polyvinylpyrrolidone, pregelatinized corn starch, sodium starch glycolate, stearic acid
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
call 804-270-4498, 8.30 am-4.30 pm ET, Monday — Friday
Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma — TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:
Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.
Cookeville, TN 38506
NDC 71610-238 — Acetaminophen, USP 325 mg Tablets — Rx Only
| ACETAMINOPHEN |
|Labeler — Aphena Pharma Solutions — Tennessee, LLC (128385585)|
|Aphena Pharma Solutions — Tennessee, LLC||128385585||REPACK (71610-238)|
Revised: 02/2019 Aphena Pharma Solutions — Tennessee, LLC
Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.