... used, as provided in Sec. 330.1 (c )( 2 ), subject to the provisions of section 502 of the Act relating to misbranding and the prohibition in section 301 (d) of the Act against the introduction or delivery for introduction into interstate commerce of unapproved new drugs in violation of section 505 (a) of the Act. (c) Warnings. The labeling of the product contains the following warnings under the heading `` Warnings: (1) `` The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heart beat ' (2) `` For occasional use only. Not intended for use as a substitute for sleep. If fatigue or drowsiness persists or continues to recur, consult a ' (select one of the following: `` physician ' or `` doctor). (3) `` Do not give to children under 12 years of ...

... [Code of Federal Regulations] [Title 21, Volume 3] [Revised as of April 1, 2009] From the U.S. Government Printing Office via GPO Access [CITE: 21CFR182.1180] [Page 478] TITLE 21 -FOOD AND DRUGS CHAPTER I -FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) PART 182_SUBSTANCES GENERALLY RECOGNIZED AS SAFE -Table of Contents Subpart B_Multiple Purpose GRAS Food Substances Sec. 182.1180 Caffeine. (a) Product. Caffeine. (b) Tolerance. 0.02 percent. (c) Limitations, restrictions, or explanation. This substance is generally recognized as safe when used in cola-type beverages in accordance with good manufacturing practice. ...

... [Code of Federal Regulations] [Title 21, Volume 5] [Revised as of April 1, 2009] From the U.S. Government Printing Office via GPO Access [CITE: 21CFR340.10] [Page 237] TITLE 21 -FOOD AND DRUGS CHAPTER I -FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) PART 340_STIMULANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE -Table of Subpart B_Active Ingredient Sec. 340.10 Stimulant active ingredient. The active ingredient of the product consists of caffeine when used within the dosage limits established in Sec. 340.50 (d). ...

... residue from the extraction of hops, at a level not to exceed 2.2 percent, Provided, That: (1) The hops extract is added to the wort before or during cooking in the manufacture of beer. (2) The label of the hops extract identifies the presence of the methylene chloride and provides for the use of the hops extract only as prescribed by paragraph (b )( 1) of this section. (c) In coffee as a residue from its use as a solvent in the extraction of caffeine from green coffee beans, at a level not to exceed 10 parts per million (0.001 percent) in decaffeinated roasted coffee and in decaffeinated soluble coffee extract (instant coffee). ...

... Povidone-vinylacetate copolymers Salicylic acid Simethicone Tannic acid Topical starch Trolamine Turpentine oil Zirconium oxide Zyloxin (B) Ingredients -Approved as of June 4, 2004; June 6, 2005, for products with annual sales less than $25, 000. Beeswax Bismuth subnitrate Boric acid Cetyl alcohol Glyceryl stearate Isopropyl palmitate Live yeast cell derivative Shark liver oil Stearyl alcohol (19) [Reserved] (20) Weight control drug products. Alcohol Alfalfa Alginic acid Anise oil Arginine Ascorbic acid Bearberry Biotin Bone marrow, red Buchu Buchu, potassium extract Caffeine Caffeine citrate Calcium Calcium carbonate Calcium caseinate Calcium lactate Calcium pantothenate Carboxymethylcellulose sodium Carrageenan Cholecalcierol Choline Chondrus Citric acid Cnicus benedictus Copper Copper gluconate Corn oil Corn syrup Corn silk, potassium extract Cupric sulfate Cyanocobalamin (vitamin B12) Cystine Dextrose Docusate sodium Ergocalciferol Ferric ammonium citrate Ferric pyrophosphate Ferrous fumarate Ferrous gluconate Ferrous sulfate (iron) Flax seed Folic acid Fructose Guar gum Histidine Hydrastis canadensis Inositol Iodine Isoleucine Juniper, potassium extract Karaya gum Kelp Lactose Lecithin Leucine Liver concentrate Lysine Lysine hydrochloride Magnesium Magnesium oxide Malt Maltodextrin Manganese citrate Mannitol Methionine Methylcellulose Mono-and di-glycerides ...

... flavorings. 182.50 Certain other spices, seasonings, essential oils, oleoresins, and natural extracts. 182.60 Synthetic flavoring substances and adjuvants. 182.70 Substances migrating from cotton and cotton fabrics used in dry food packaging. 182.90 Substances migrating to food from paper and paperboard products. 182.99 Adjuvants for pesticide chemicals. 182.1045 Glutamic acid. 182.1047 Glutamic acid hydrochloride. 182.1057 Hydrochloric acid. 182.1073 Phosphoric acid. 182.1087 Sodium acid pyrophosphate. 182.1125 Aluminum sulfate. 182.1127 Aluminum ammonium sulfate. 182.1129 Aluminum potassium sulfate. 182.1131 Aluminum sodium sulfate. 182.1180 Caffeine. 182.1217 Calcium phosphate. 182.1235 Caramel. 182.1320 Glycerin. 182.1480 Methylcellulose. 182.1500 Monoammonium glutamate. 182.1516 Monopotassium glutamate. 182.1711 Silica aerogel. 182.1745 Sodium carboxymethylcellu lose. 182.1748 Sodium caseinate. 182.1778 Sodium phosphate. 182.1781 Sodium aluminum phosphate. 182.1810 Sodium tripolyphosphate. 182.2122 Aluminum calcium silicate. 182.2227 Calcium silicate. 182.2437 Magnesium silicate. 182.2727 Sodium aluminosilicate. 182.2729 Sodium calcium aluminosilicate, hydrated. 182.2906 Tricalcium silicate. 182.3013 Ascorbic acid. 182.3041 Erythorbic acid. 182.3089 Sorbic acid. 182.3109 Thiodipropionic acid. 182.3149 Ascorbyl palmitate. 182.3169 Butylated hydroxyanisole. 182.3173 ...