Acetaminophen Extra Strength 500 mg/1
Acetaminophen · TABLET · Better Living Brands LLC
Acetaminophen Extra Strength is a tablet containing acetaminophen at 500 mg/1, taken oral. Manufactured by Better Living Brands LLC.
Key Facts
- Brand Name
- Acetaminophen Extra Strength
- Generic Name
- Acetaminophen
- NDC Code (Product)
21130-155- Manufacturer
- Better Living Brands LLC
- Strength
- 500 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- M013
- Marketing Start
- 07/14/2023
Recall History
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.
Medline Industries Inc
Labeling: Label Error on Declared Strength- Bottles containing 500 mg acetaminophen tablets mislabeled to contain 325 mg tablets.
GlaxoSmithkline Consmer Healthcare
Failed Dissolution Specifications
Kenvue Brands LLC
Defective Container
LNK International, Inc.
Labeling: Not Elsewhere Classified The primary label contains the words "enteric coated" but the tablet is not enteric coated and should only say 'coated tablet'
A-S Medication Solutions LLC
Labeling: Label Mix-Up: Some bottles of Acetaminophen Extra Strength 500 mg tablets were incorrectly labeled with the drug facts label for Aspirin 81 mg tablets.
Akron Pharma, Inc.
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Akron Pharma, Inc.
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
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 muscular aches backache minor pain of arthritis the common cold 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 gelcaps every 6 hours while symptoms last do not take more than 6 gelcaps in 24 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 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 Acetaminophen Extra Strength used for?
Acetaminophen Extra Strength contains Acetaminophen. It is a tablet taken oral. Consult your doctor for specific uses.
Is Acetaminophen Extra Strength a controlled substance?
Acetaminophen Extra Strength is not classified as a controlled substance by the DEA.
What is the generic name for Acetaminophen Extra Strength?
The generic name for Acetaminophen Extra Strength is Acetaminophen. There are 12 other brand versions of Acetaminophen.
What is the NDC code for Acetaminophen Extra Strength 500 mg/1?
The NDC (National Drug Code) for Acetaminophen Extra Strength 500 mg/1 is 21130-155, listed by Better Living Brands 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)