Acesulfame Potassium
Excipient (pharmacologically inactive substance)
What is it?
The most common artificial sweeteners available in the U.S. include acesulfame potassium, aspartame, neotame, saccharin, sucralose and stevia glycosides. Consumers may choose these products to lower the risk of tooth decay, manage or help lose weight, or use in the management of diabetes.
Acesulfame potassium, or acesulfame (Sunett, Sweet One) is an artificial sweetener that is 200 times more sweet than sugar but has zero caloric content. Acesulfame has an acceptable daily intake (ADI) of 15 mg/kg of body weight per day. The ADI is defined as the estimated amount that a person can safely consume on average every day over a lifetime without risk. It is estimated that the average daily intake is about 20 percent of the ADI. Acesulfame is not metabolized in the body.
Roughly 90 countries permit the use of acesulfame - the U.S. Food and Drug Administration approved it in 1988. It is approved for use in foods, alcoholic and non-alcoholic beverages, carbonated beverages, and as a general purpose sweetener. The FDA considers acesulfame safe for use within the specified limits based on multiple safety studies, and no human health problems have been reported despite 15 years of extensive use.[1][2]
[1] Kroger M, Meister K, Kava R. Low calorie sweeteners and other sugar substitutes: A review of the safety issues. Comprehensive Revews in Food Science and Food Safety 2006.Vol. 5:35-47 Accessed 8/20/2012. http://onlinelibrary.wiley.com/store/10.1111/j.1541-4337.2006.tb00081.x/asset/j.1541-4337.2006.tb00081.x.pdf?v=1&t=h646f70n&s=33a95146f72338e1a90def263de726bd8f7aba59
[2] NTP toxicology studies of acesulfame potassium (CAS No. 55589-62-3) in genetically modified (FVB Tg.AC Hemizygous) mice and carcinogenicity studies of acesulfame potassium in genetically modified [B6.129-Trp53 (tm1Brd) (N5) Haploinsufficient] mice (feed studies). Natl Toxicol Program Genet Modif Model Rep. 2005 Oct;(2):1-113. Accessed 8/20/2012 mice.http://www.ncbi.nlm.nih.gov/pubmed/18784762
Top Medications with this excipient
- Abilify Discmelt 15 mg (Bristol-Myers Squibb)
- Abilify Discmelt 10 mg (Bristol-Myers Squibb)
- Acetaminophen 500 mg (AAA Pharmaceutical, Inc.)
- Acetaminophen, Chlorpheniramine and Phenylephrine acetaminophen 325 mg / chlorpheniramine 2 mg / phenylephrine 5 mg (H E B)
- Acetaminophen, Chlorpheniramine Maleate and Phenylephrine Hydrochloride 325 mg / 2 mg / 5 mg (AAA Pharmaceutical, Inc.)
- Acetaminophen, Chlorpheniramine, Dextromethorphan and Phenylephrine acetaminophen 325 mg / chlorpheniramine 2 mg / dextromethorphan 10 mg / phenylephrine 5 mg (American Sales Company)
- Acetaminophen, Chlorpheniramine, Dextromethorphan and Phenylephrine acetaminophen 325 mg / chlorpheniramine 2 mg / dextromethorphan 10 mg / phenylephrine 5 mg (American Sales Company)
- Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin and Phenylephrine Hydrochloride 325 mg / 10 mg / 200 mg / 5 mg (AAA Pharmaceutical, Inc.)
- Advil Congestion Relief ibuprofen 200 mg / phenylephrine 10 mg (Pfizer Consumer Healthcare)
- Binosto 70 mg (Mission Pharmacal Company)
- Buprenorphine Hydrochloride and Naloxone Hydrochloride (Sublingual) 8 mg (base) / 2 mg (base) (Amneal Pharmaceuticals)
- Buprenorphine Hydrochloride and Naloxone Hydrochloride (Sublingual) 2 mg (base) / 0.5 mg (base) (Amneal Pharmaceuticals)
- Cetirizine Hydrochloride (chewable) 10 mg (Sandoz Pharmaceuticals Inc.)
- Cetirizine Hydrochloride (chewable) 5 mg (Sandoz Pharmaceuticals Inc.)
- Cold Head Congestion acetaminophen 325 mg / dextromethorphan 10 mg / guaifenesin 200 mg / phenylephrine 5 mg (American Sales Company)
- Cold Multi-Symptom Severe acetaminophen 325 mg / dextromethorphan 10 mg / guaifenesin 200 mg / phenylephrine 5 mg (Kroger Company)
- Ibuprofen (Chewable) 100 mg (McKesson)
- Ibuprofen (Chewable) 100 mg (Walgreen Company)
- MOTRIN JUNIOR 100 MG (McNeil Consumer)
- Risperidone (Orally Disintegrating) 1 mg (Jubilant Cadista Pharmaceuticals Inc.)
