Drugplain

Aphen 325 mg/1

acetaminophen · TABLET · Asclemed USA, Inc.

No Recall HistoryCurrently in Shortage
Plain English

Aphen is an over-the-counter oral tablet containing 325 mg of acetaminophen, a common pain reliever and fever reducer used to treat mild to moderate pain and fever. It is taken by mouth and is available without a prescription.

Key Facts

Brand Name
Aphen
Generic Name
acetaminophen
NDC Code (Product)
76420-372
Manufacturer
Asclemed USA, Inc.
Strength
325 mg/1
Dosage Form
TABLET
Route
ORAL
Marketing Status
Application #
M013
Marketing Start
09/04/2020

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

off label use22,386 reports
fatigue20,435 reports
drug ineffective18,155 reports
pain18,103 reports
nausea17,623 reports
headache16,714 reports
toxicity to various agents15,539 reports
dyspnoea14,575 reports
arthralgia14,309 reports
pyrexia14,271 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses temporary relieves of minor aches and pains due to: headache muscular aches backache minor pain of arthritis the common cold toothache premenstrual and menstrual cramps temporarily reduces fever

Dosage & Administration

Directions Adults and children 12 years of age and older: 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 of age: ask a doctor.

Warnings

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 4,000mg 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 non-prescription). 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 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 than

Frequently Asked Questions

What is Aphen used for?

Aphen is an over-the-counter oral tablet containing 325 mg of acetaminophen, a common pain reliever and fever reducer used to treat mild to moderate pain and fever. It is taken by mouth and is available without a prescription.

Is Aphen a controlled substance?

Aphen is not classified as a controlled substance by the DEA.

What is the generic name for Aphen?

The generic name for Aphen is acetaminophen. There are 12 other brand versions of acetaminophen.

What is the NDC code for Aphen 325 mg/1?

The NDC (National Drug Code) for Aphen 325 mg/1 is 76420-372, listed by Asclemed USA, Inc..