Extra strength Acetaminophen PM 500 mg/1

Acetaminophen 500mg/ Diphenhydramine HCl 25mg · TABLET · TIME CAP LABS INC

No Recall HistoryCurrently in Shortage

Plain English

Extra strength Acetaminophen PM is a tablet containing acetaminophen 500mg/ diphenhydramine hcl 25mg at 500 mg/1, taken oral. Manufactured by TIME CAP LABS INC.

Key Facts

Brand Name: Extra strength Acetaminophen PM
Generic Name: Acetaminophen 500mg/ Diphenhydramine HCl 25mg
NDC Code (Product): 49483-430
Manufacturer: TIME CAP LABS INC
Strength: 500 mg/1
Dosage Form: TABLET
Route: ORAL
Marketing Status
Application #: M013
Marketing Start: 07/22/2023

Recall History

No Recall History

Side Effects Reported to FDA

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

completed suicide194 reports

toxicity to various agents148 reports

death43 reports

drug toxicity36 reports

cardio-respiratory arrest32 reports

intentional product misuse30 reports

fatigue27 reports

pain27 reports

drug ineffective25 reports

somnolence22 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 PM used for?

Extra strength Acetaminophen PM contains Acetaminophen 500mg/ Diphenhydramine HCl 25mg. It is a tablet taken oral. Consult your doctor for specific uses.

Is Extra strength Acetaminophen PM a controlled substance?

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

What is the generic name for Extra strength Acetaminophen PM?

The generic name for Extra strength Acetaminophen PM is Acetaminophen 500mg/ Diphenhydramine HCl 25mg. There are no other listed brand versions of Acetaminophen 500mg/ Diphenhydramine HCl 25mg.

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

The NDC (National Drug Code) for Extra strength Acetaminophen PM 500 mg/1 is 49483-430, listed by TIME CAP LABS INC.

Product NDC

49483-430

Package NDC

49483-430-40

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

Data from openFDA · Public domain (CC0 1.0)