Reducing Fever in Children: Safe Use of Acetaminophen

To find out if an over-the-counter medicine contains acetaminophen, look for “acetaminophen” on the Drug Facts label under the section called “Active Ingredient.” Get hi-res version of this photo on Flickr. You’re in the drug store, looking for a fever-reducing medicine for your children. They range in age from 6 months to 7 years, and…

Hikma Pharmaceuticals USA Inc. Extends Voluntary Nationwide Recall of Ketorolac Tromethamine Injection, USP 30mg/mL, 1mL Fill/2mL Vials Due to the Potential Presence of Small Particulates

Summary Company Announcement Date: March 04, 2020 FDA Publish Date: March 05, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Potential Presence of Small Particulates Company Name: Hikma Pharmaceuticals USA Inc. Brand Name: Brand Name(s) Product Description: Product Description Ketorolac Tromethamine Injection, USP 30mg/mL, 1 mL Vial Company Announcement Hikma Pharmaceuticals PLC (Hikma,…

Nutrition

The Nutrition Facts Label on food packaging is an important and easy way to get essential information to help you make healthy food choices. The following Consumer Updates are also a great resource for more nutrition facts, and other helpful information about the food you eat. Nutrition Food & Beverages Content current as of: 04/22/2019…

Singulair (montelukast) and All Montelukast Generics: Strengthened Boxed Warning – Due to Restricting Use for Allergic Rhinitis

[Posted 03/04/2020] AUDIENCE: Patient, Health Professional, Pharmacy, Allergy and Immunology ISSUE: FDA is strengthening existing warnings about serious behavior and mood-related changes with montelukast (Singulair and generics), which is a prescription medicine for asthma and allergy. FDA is taking this action after a review of available information that led us to reevaluate the benefits and risks…

Nutrition Facts Label Better Informs Your Food Choices

Español A lot has changed in the American diet since the Nutrition Facts label was introduced in 1993 to provide important nutrition information on food packages. The U.S. Food and Drug Administration (FDA) has brought this familiar rectangular box—one of the most recognized graphics in the world—up to date with changes to its design and…

SweynTooth Cybersecurity Vulnerabilities May Affect Certain Medical Devices: FDA Safety Communication

The U.S. Food and Drug Administration (FDA) is informing patients, health care providers, and manufacturers about the SweynTooth family of cybersecurity vulnerabilities, which may introduce risks for certain medical devices. The FDA is not aware of any confirmed adverse events related to these vulnerabilities. Software to exploit these vulnerabilities in certain situations is already publicly…

Continuous Positive Airway Pressure (CPAP) Machine Cleaning

[embedded content] Español If you use a CPAP machine at night to help you breathe during sleep, you know it can be difficult to keep up a regular cleaning schedule. A dirty CPAP machine contaminated with germs like viruses and bacteria can make you sick. So automated machines advertised on TV that claim to clean…

Report Kids’ Problems With Medical Products

Español Consumers can play a critical role in helping the Food and Drug Administration (FDA) assure children’s access to safe medical products. Reporting to FDA such “adverse events” as unexpected, serious side effects, accidental exposure, and product quality issues can prompt the agency to act—and it can also bring new pediatric safety information to light….

Safely Soothing Teething Pain and Sensory Needs in Babies and Older Children

Consider treating teething pain with a teething ring made of firm rubber (not frozen) or by rubbing the gums with a clean finger. Español Teething is normal but may be a painful experience for infants and toddlers. Too often, well-meaning parents and caregivers who want to ease a child’s pain turn to medications and products…