Spilling the Beans: How Much Caffeine is Too Much?

… drink coffee or tea first thing in the morning, hoping the caffeine in it will jump-start your day? Do you follow it up … According to medical experts, including here at the FDA, caffeine can be part of a healthy diet for most people, but … can vary from person to person. Be aware of the level of caffeine in your diet and look out for signs when it’s too …

Pure and Highly Concentrated Caffeine

… Pure and highly concentrated caffeine products present a significant public health threat … products consisting of pure or highly concentrated caffeine in powder and liquid forms have emerged on the … a safe amount and a toxic or life-threatening amount of caffeine in these highly concentrated products is very small. …

FDA Warns Consumers About Pure and Highly Concentrated Caffeine

… supplements consisting of pure or highly concentrated caffeine, and recommends avoiding these products. In … the FDA is concerned about pure and highly concentrated caffeine, in powdered and liquid forms, sold in bulk … healthy individuals. Pure and highly concentrated caffeine is extremely potent. A single teaspoon of pure …

Guidance for Industry: Highly Concentrated Caffeine in Dietary Supplements

… of or containing only pure or highly concentrated caffeine have been linked to at least two deaths in the … consist of only or primarily pure or highly concentrated caffeine are sold as dietary supplements. FDA considers some … products that contain pure or highly concentrated caffeine, or are considering doing so. This guidance should …

FDA warns companies to stop selling dangerous and illegal pure and highly concentrated caffeine products

… and Mind for illegally selling certain highly concentrated caffeine products. The FDA considers these products to be a … informed of the dangers of highly concentrated and pure caffeine, we’re still finding companies that are disregarding … products with potentially dangerous and lethal amounts of caffeine. The FDA recently took action to explain which pure …

FDA takes step to protect consumers against dietary supplements containing dangerously high levels of extremely concentrated or pure caffeine

… consumers from the dangers of highly concentrated and pure caffeine products. These products present a significant … potentially dangerous doses. Highly concentrated and pure caffeine, often sold in bulk packages, have been linked to at … dietary supplements containing pure or highly concentrated caffeine in powder or liquid forms are considered unlawful …

Aurobindo Pharma USA, Inc. on Behalf of AuroHealth, Issues Voluntary Nationwide Recall of one (1) Lot of Healthy Living Over the Counter (OTC) Migraine Relief: Acetaminophen 250mg; Aspirin 250mg; Caffeine 65mg Tablets, Due to Missing Manufacturer Label

… Relief, Acetaminophen 250mg, Aspirin (NSAID) 250mg & Caffeine 65mg tablets, to the consumer level as sold through … Expiry 58602-882-21 Acetaminophen 250mg; Aspirin 250mg; Caffeine 65mg tablets – 100ct bottles AC2523005A June-2025 … Living Migraine Relief, Acetaminophen, Aspirin (NSAID) & Caffeine tablets are indicated for temporarily relief of …

Caffeinated Alcoholic Beverages

… November 17, 2010 FDA warned four companies that the caffeine added to their alcoholic malt beverages is an … Alcohol Drinks TTB - Alcohol Beverages with Added Caffeine … Human Foods Program … FDA warned four companies that the caffeine added to alcoholic malt beverages is an unsafe food …

Laboratory Analysis of Homeopathic Teething Tablets

… (atropine and scopolamine) content and coffea cruda (caffeine) content is not uniform among the manufactured … Analyzed Belladonna alkaloid – Scopolamine Coffea Cruda – Caffeine Identified Levels/Range (nanograms) Identified … (atropine and scopolamine) content and coffea cruda (caffeine) content is not uniform. FDA … Laboratory Analysis …

Guidance for Industry: Highly Concentrated Caffeine in Dietary Supplements DOWNLOAD

… Highly Concentrated Caffeine in Dietary Supplements: Guidance for Industry … Dietary Supplements Containing Highly Concentrated Caffeine … Liquid Dietary Supplements Containing Highly Concentrated Caffeine .. 5 IV. Guidance on Producing Safer Dietary Supplements Containing Caffeine .. 6 V. References …

Eagle Energy USA, Inc. - 617712 - 12/01/2021

… 2021 and has determined that you take orders there for “Caffeine Pen” products packaged as “Lychee Ice” and “Guarana Berry” (hereinafter referred to as your “Caffeine Pen” products). We have also reviewed your social … home page at www.fda.gov. Furthermore, the use of your “Caffeine Pen” products raises safety concerns for the agency …

LiquidCaffeine.com - 545456 - 05/29/2018

… Food and Drug Administration (FDA) purchased your Liquid Caffeine product and reviewed its label. Also, in March 2018, … your website, www.liquidcaffeine.com, where your Liquid Caffeine product is labeled and offered for sale as a dietary …   Based on our review, we have determined that your Liquid Caffeine product is adulterated within the meaning of section …

Trippo International LLC - 612586 - 03/10/2021

… (FDA) reviewed the label for your 16-ounce Super Caffeine (Anhydrous) product, which is labeled and offered … to be offered in powdered form, and its labeling lists “caffeine anhydrous” as the sole ingredient. Based on our review, we have determined that your 16-ounce Super Caffeine (Anhydrous) product is adulterated within the …

Dual Health Body and Mind - 545453 - 05/29/2018

… Administration (FDA) reviewed the label for your 8 ounce Caffeine Anhydrous Powder product, which is labeled and … in powdered form, and its labeling lists “100% pure Caffeine Powder” as the sole ingredient.   Based on our review, we have determined that your 8 ounce Caffeine Anhydrous Powder product is adulterated within the …

TeaTaze, LLC - 613942 - 07/23/2021

… Detox, Tokusen Hinshucha Fuji Midori Green, Vibrant Green, Caffeine-Free Herbal Energy, Ignited Oolong Slimming, Power … in staving off chronic health conditions down the road.” Caffeine-Free Herbal Energy tea, also referenced as Fresh … Detox, Tokusen Hinshucha Fuji Midori Green, Vibrant Green, Caffeine-Free Herbal Energy, Ignited Oolong Slimming, Power …

NDC Number and Proprietary Name for the approved and marketed codeine and dihydrocodeine containing products as of November 12, 2013

… Codeine Phosphate 00143-3000 Butalbital, Acetaminophen and Caffeine with Codeine Phosphate 00185-0749 Carisoprodol, … VC WITH CODEINE 00527-1312 Butalbital, Aspirin, Caffeine and Codeine Phosphate 00591-3220 Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate 00591-3546 Butalbital, …

FDA Drug Safety Communication: Prescription Acetaminophen Products to be Limited to 325 mg Per Dosage Unit; Boxed Warning Will Highlight Potential for Severe Liver Failure

… 150mg; 180mg; 30mg No Current Brand Name Acetaminophen; Caffeine; Dihydrocodeine Bitartrate Capsule; Oral 356.4mg; 30mg; 16mg No Current Brand Name Acetaminophen; Caffeine; Dihydrocodeine Bitartrate Tablet; Oral 712.8mg; … 60mg No Current Brand Name Acetaminophen; Butalbital; Caffeine Tablet; Oral 500mg; 50mg; 40mg Esgic-Plus …

Safety Labeling Change Orders

… 10/24/2013 ANDA-040261 Acetaminophen, Butalbital, and Caffeine WEST-WARD PHARMACEUTICALS CORP Archive 10/24/2013 … 10/24/2013 ANDA-040864 Acetaminophen, Butalbital, and Caffeine MIRROR PHARMACEUTICALS LLC Archive 10/24/2013 … 10/24/2013 ANDA-040336 Acetaminophen, Butalbital, and Caffeine  WEST-WARD PHARMACEUTICALS CORP Archive 10/24/2013 …

FDA Notification Regarding Isometheptene-Containing Drug Products

… and acetaminophen or isometheptene mucate, caffeine, and acetaminophen). As of January 1, 2018, all of … and Acetaminophen 35573-310 Isometheptene Mucate, Caffeine, and Acetaminophen 35573-311 Isometheptene Mucate, … 42195-145 Isometheptene Mucate, Caffeine, and Acetaminophen 15014-145 Prodrin 58657-401 …

List of Affected Prescription Acetaminophen Manufacturers

… 18458 00024-1937-04 FIORICET W/ CODEINE (APAP; BUTALBITAL; CAFFEINE; CODEINE) CAPSULE WATSON 20232 52544-0958-01 …   TABLET; ORAL VALEANT 87811   ACETAMINOPHEN; BUTALBITAL; CAFFEINE CAPSULE; ORAL MIKART 89007     CAPSULE; ORAL NEXGEN … ORAL WATSON LABS 88616   ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE CAPSULE; ORAL NEXGEN PHARMA INC …

Rulemaking History for OTC Stimulant Drug Product

… 3/21/1980 45FR18399 Notice: Prohibits combination of caffeine, PPA, and ephedrine 8/13/1982 47FR35344 Notice: Prohibits combination of caffeine, PPA, and ephedrine; allows only caffeine 11/18/1983 48FR52513 Final Rule Date FR Citation …

5 Health Tips College Women Need to Know

… Most adults need 7 – 8 hours of sleep each night. Limiting caffeine and passing on naps after 3 p.m. can help you get a … side effects and affect your driving. Avoid Pure Powdered Caffeine – Pure powdered caffeine  is a powerful stimulant. You may think it can help …

January - March 2023 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)

… (buprenorphine hydrochloride) Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules Butrans … buccal tablet) Fiorinal with Codeine (butalbital, aspirin, caffeine and codeine phosphate) Hydromorphone Hydrochloride … Sufentanil Citrate Injection Synalgos-DC (aspirin, caffeine, and dihydrocodeine bitartrate) Ultiva (remifentanil …

Leave Chocolate Out of Rover's Celebrations

… two compounds that are toxic to dogs, theobromine and caffeine. Both compounds are stimulants, acting on the … People can metabolize (break down) theobromine and caffeine in their body fairly quickly, so the side effects … last longer. Chocolate contains more theobromine than caffeine; it’s the theobromine that’s the main culprit in …

What the FDA is Doing to Protect Consumers from Cannabidiol (CBD) in Foods

… the body. Studies suggest CBD may increase and/or prolong caffeine’s effects, which could be a problem for people who are sensitive to caffeine. Additionally, using food to administer CBD makes it … mistaken for traditional foods, and caffeinated beverages. Caffeine is one of CBD’s possible drug interactions. While we …