Acetaminophen Regular strength 325 mg/1

Acetaminophen · TABLET · PD-Rx Pharmaceuticals, Inc.

2 Recalls on RecordCurrently in Shortage

Plain English

Acetaminophen Regular strength is a tablet containing acetaminophen at 325 mg/1, taken oral. Manufactured by PD-Rx Pharmaceuticals, Inc..

Key Facts

Brand Name: Acetaminophen Regular strength
Generic Name: Acetaminophen
NDC Code (Product): 55289-563
Manufacturer: PD-Rx Pharmaceuticals, Inc.
Strength: 325 mg/1
Dosage Form: TABLET
Route: ORAL
Marketing Status
Application #: M013
Marketing Start: 01/09/2007

Recall History

2 Recalls on Record

Class I09/25/2015

Medline Industries Inc

Labeling: Label Error on Declared Strength- Bottles containing 500 mg acetaminophen tablets mislabeled to contain 325 mg tablets.

TerminatedVoluntary: Firm initiated

Class III12/12/2024

Akron Pharma, Inc.

Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.

OngoingVoluntary: Firm initiated

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 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

Dosage & Administration

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 do not use for more than 10 days unless directed by a doctor children 6-11 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

Warnings

Warnings Liver warning This product contains acetaminophen. 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 the user is 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 than 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 …

Frequently Asked Questions

What is Acetaminophen Regular strength used for?

Acetaminophen Regular strength contains Acetaminophen. It is a tablet taken oral. Consult your doctor for specific uses.

Is Acetaminophen Regular strength a controlled substance?

Acetaminophen Regular strength is not classified as a controlled substance by the DEA.

What is the generic name for Acetaminophen Regular strength?

The generic name for Acetaminophen Regular strength is Acetaminophen. There are 12 other brand versions of Acetaminophen.

What is the NDC code for Acetaminophen Regular strength 325 mg/1?

The NDC (National Drug Code) for Acetaminophen Regular strength 325 mg/1 is 55289-563, listed by PD-Rx Pharmaceuticals, Inc..

Product NDC

55289-563

Package NDC

55289-563-09

Other Acetaminophen Brands

See all →

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)