Drugplain

Extra Strength Acetaminophen 500 mg/1

Acetaminophen · TABLET · Geri-Care Pharmaceutical Corp

6 Recalls on RecordCurrently in Shortage
Plain English

Extra Strength Acetaminophen is a tablet containing acetaminophen at 500 mg/1, taken oral. Manufactured by Geri-Care Pharmaceutical Corp.

Key Facts

Brand Name
Extra Strength Acetaminophen
Generic Name
Acetaminophen
NDC Code (Product)
57896-219
Manufacturer
Geri-Care Pharmaceutical Corp
Strength
500 mg/1
Dosage Form
TABLET
Route
ORAL
Marketing Status
Application #
M013
Marketing Start
11/01/2024

Recall History

6 Recalls on Record
Class II02/03/2020

Contract Pharmacal Corporation

Presence of Foreign Tablets/Capsules: Complaint involving one Women's Prenatal dietary supplement tablet commingled in a bottle of Extra Strength Acetaminophen 500 mg contents 1000 count bottle.

TerminatedVoluntary: Firm initiated
Class II06/18/2013

Novartis Consumer Health

Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.

TerminatedVoluntary: Firm initiated
Class II02/03/2020

Contract Pharmacal Corporation

Presence of Foreign Tablets/Capsules: Complaint involving one Women's Prenatal dietary supplement tablet commingled in a bottle of Extra Strength Acetaminophen 500 mg contents 1000 count bottle.

TerminatedVoluntary: Firm initiated
Class II05/20/2024

Contract Pharmacal Corporation

Discoloration: Brownish tablets

OngoingVoluntary: Firm initiated
Class III10/13/2021

Ultra Seal Corporation

Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.

TerminatedVoluntary: Firm initiated
Class II06/06/2013

Novartis Consumer Health

Defective container: products are packaged in pouches which may not have been fully sealed

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

off label use22,394 reports
fatigue20,450 reports
drug ineffective18,166 reports
pain18,121 reports
nausea17,635 reports
headache16,721 reports
toxicity to various agents15,674 reports
dyspnoea14,584 reports
arthralgia14,319 reports
pyrexia14,274 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness

Dosage & Administration

Directions Do not take more than directed. See overdose warning adults and children 12 years and over take 2 caplets at bedtime do not take more than 2 caplets of this product in 24 hours children under 12 years do not use

Warnings

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.

Frequently Asked Questions

What is Extra Strength Acetaminophen used for?

Extra Strength Acetaminophen contains Acetaminophen. It is a tablet taken oral. Consult your doctor for specific uses.

Is Extra Strength Acetaminophen a controlled substance?

Extra Strength Acetaminophen is not classified as a controlled substance by the DEA.

What is the generic name for Extra Strength Acetaminophen?

The generic name for Extra Strength Acetaminophen is Acetaminophen. There are 12 other brand versions of Acetaminophen.

What is the NDC code for Extra Strength Acetaminophen 500 mg/1?

The NDC (National Drug Code) for Extra Strength Acetaminophen 500 mg/1 is 57896-219, listed by Geri-Care Pharmaceutical Corp.