ACETAMINOPHEN 500 MG 500 mg/1
ACETAMINOPHEN · TABLET · Pioneer Life Sciences, LLC
Acetaminophen is an over-the-counter pain reliever and fever reducer commonly used to treat minor aches, pains, and fevers. This tablet form contains 500 mg of acetaminophen per dose and is taken by mouth.
Key Facts
- Brand Name
- ACETAMINOPHEN 500 MG
- Generic Name
- ACETAMINOPHEN
- NDC Code (Product)
72090-038- Manufacturer
- Pioneer Life Sciences, LLC
- Strength
- 500 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- M013
- Marketing Start
- 01/09/2025
Recall History
ULTRAtab Laboratories, Inc.
CGMP Deviations
A-S Medication Solutions LLC.
Labeling: Label Mix-up; The bottle of over-the-counter Acetaminophen 500mg Extra Strength, 100 count, included in Health Essential Kits, labeled incorrectly with a prescription drug label instead of an OTC drug label.
ULTRAtab Laboratories, Inc.
CGMP Deviations
Ultra Seal Corporation
cGMP deviations
ULTRAtab Laboratories, Inc.
CGMP Deviations
Novartis Consumer Health
Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
Ultra Seal Corporation
cGMP deviations
ULTRAtab Laboratories, Inc.
CGMP Deviations
ULTRAtab Laboratories, Inc.
CGMP Deviations
Ultra Seal Corporation
cGMP deviations
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
Uses temporarily relieves minor aches and pains due to: the common cold headache backache minor pain of arthritis muscular aches toothache 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 Caplets every 6 hours while symptoms last do not take more than 6 caplets in hours, unless directed by a doctor do not use for more than 10 days unless directed by a doctor Children under 12 Years ask a doctor
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
Frequently Asked Questions
What is ACETAMINOPHEN 500 MG used for?
Acetaminophen is an over-the-counter pain reliever and fever reducer commonly used to treat minor aches, pains, and fevers. This tablet form contains 500 mg of acetaminophen per dose and is taken by mouth.
Is ACETAMINOPHEN 500 MG a controlled substance?
ACETAMINOPHEN 500 MG is not classified as a controlled substance by the DEA.
What is the generic name for ACETAMINOPHEN 500 MG?
The generic name for ACETAMINOPHEN 500 MG is ACETAMINOPHEN. There are 12 other brand versions of ACETAMINOPHEN.
What is the NDC code for ACETAMINOPHEN 500 MG 500 mg/1?
The NDC (National Drug Code) for ACETAMINOPHEN 500 MG 500 mg/1 is 72090-038, listed by Pioneer Life Sciences, LLC.
Other Acetaminophen Brands
See all →- acetaminophen500 mg/172162-2163
- Combogesic325 mg/172260-129
- basic care nighttime severe cold and flu650 mg/30mL72288-189
- basic care migraine relief250 mg/172288-374
- basic care nighttime cold and flu650 mg/30mL72288-459
- Basic Care Dual Action250 mg/172288-530
- basic care infants pain and fever160 mg/5mL72288-590
- basic care acetaminophen650 mg/172288-634
- AMAZON BASIC CARE ACETAMINOPHEN650 mg/172288-698
- basic care nighttime severe cold and flu325 mg/172288-721
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)