Pain Reliever 500 mg/1
ACETAMINOPHEN · TABLET · Magno-Humphries, Inc.
Pain Reliever is a tablet containing acetaminophen at 500 mg/1, taken oral. Manufactured by Magno-Humphries, Inc..
Key Facts
- Brand Name
- Pain Reliever
- Generic Name
- ACETAMINOPHEN
- NDC Code (Product)
54257-473- Manufacturer
- Magno-Humphries, Inc.
- Strength
- 500 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- M013
- Marketing Start
- 01/24/2020
Recall History
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.
Reckitt Benckiser LLC
Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of the label, however the back of the bottle where the Drug Facts labeling is, is missing certain Active Ingredients such as acetaminophen, phenylephrine, dextromethorphan, diphenhydramine, and/or guaifenesin. As a result certain safety warnings associated with those ingredients may also be missing.
Ultra Seal Corporation
cGMP deviations
L. Perrigo Co.
Defective Delivery System: There is a remote potential that cartons of product could be co-packaged with an oral dosing syringe without dose markings.
Family Dollar Stores, Llc.
CGMP deviation: product outside labeled storage temperature requirements.
LNK International, Inc.
Incorrect/Undeclared Excipients: The firm recalled specific lots of Walgreens brand Aspirin Free Tension Headache Caplets due to the presence of sucralose, which was not declared on the label.
Ultra Seal Corporation
Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
Medline Industries Inc
Labeling: Label Error on Declared Strength- Bottles containing 500 mg acetaminophen tablets mislabeled to contain 325 mg tablets.
Ultra Seal Corporation
cGMP deviations
Granules Consumer Health Inc.
Label mix-up: Carton incorrectly labeled.
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: headache the common cold backache minor pain of arthritis toothache muscular aches premenstrual and menstrual cramps temporarily reduces fever
Dosage & Administration
Directions do not take more than directed adults and children 12 years and over take 2 gelcaps every 6 hours while symptoms last do not take more than 6 gelcaps in 24 hours, unless directed by a doctor do not take 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 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 if you are allergic to acetaminophen or any of the inactive ingredients in this product with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. Ask a doctor before use if you have liver disease. Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin. Stop use and ask a doctor if new symptoms occur pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days redness or swelling is present These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or cont…
Frequently Asked Questions
What is Pain Reliever used for?
Pain Reliever contains ACETAMINOPHEN. It is a tablet taken oral. Consult your doctor for specific uses.
Is Pain Reliever a controlled substance?
Pain Reliever is not classified as a controlled substance by the DEA.
What is the generic name for Pain Reliever?
The generic name for Pain Reliever is ACETAMINOPHEN. There are 12 other brand versions of ACETAMINOPHEN.
What is the NDC code for Pain Reliever 500 mg/1?
The NDC (National Drug Code) for Pain Reliever 500 mg/1 is 54257-473, listed by Magno-Humphries, Inc..
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)