PART 357—MISCELLANEOUS INTERNAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371. Subpart A [Reserved] Subpart B—Anthelmintic Drug Products Source: 51 FR 27759, Aug. 1, 1986, unless otherwise noted. § 357.101 Scope. (a) An over-the-counter anthelmintic drug product in a form suitable for oral administration is generally recognized as safe and effective and is not misbranded if it meets each condition in this subpart and each general condition established in § 330.1. (b) References in this subpart to regulatory sections of the Code of Federal Regulations are to chapter I of title 21 unless otherwise noted. § 357.103 Definition. As used in this subpart: Anthelmintic. § 357.110 Anthelmintic active ingredient. The active ingredient of the product is pyrantel pamoate when used within the dosage limits established in § 357.150(d)(1). § 357.150 Labeling of anthelmintic drug products. (a) Statement of identity. (b) Indication. (c) Warnings. (1) “Abdominal cramps, nausea, vomiting, diarrhea, headache, or dizziness sometimes occur after taking this drug. If any of these conditions persist consult a doctor.” (2) “If you are pregnant or have liver disease, do not take this product unless directed by a doctor.” (d) Directions. (1) Adults, children 12 years of age and over, and children 2 years to under 12 years of age: Oral dosage is a single dose of 5 milligrams of pyrantel base per pound, or 11 milligrams per kilogram, of body weight not to exceed 1 gram. Dosing information should be converted to easily understood directions for the consumer using the following dosage schedule: Weight Dosage (taken as a single dose) 1 Less than 25 pounds or under 2 years old Do not use unless directed by a doctor. 25 to 37 pounds 125 milligrams. 38 to 62 pounds 250 milligrams. 63 to 87 pounds 375 milligrams. 88 to 112 pounds 500 milligrams. 113 to 137 pounds 625 milligrams. 138 to 162 pounds 750 milligrams. 163 to 187 pounds 875 milligrams. 188 pounds and over 1,000 milligrams. 1 (2) “Read package insert carefully before taking this medication. Take only according to directions and do not exceed the recommended dosage unless directed by a doctor. Medication should only be taken on time as a single dose; do not repeat treatment unless directed by a doctor. When one individual in a household has pinworms, the entire household should be treated unless otherwise advised. See Warnings. If any worms other than pinworms are present before or after treatment, consult a doctor. If any symptoms or pinworms are still present after treatment, consult a doctor. (3) “This product can be taken any time of day, with or without meals. It may be taken alone or with milk or fruit juice. Use of a laxative is not necessary prior to, during, or after medication.” (e) Optional wording. [51 FR 27759, Aug. 1, 1986; 52 FR 7831, Mar. 13, 1987, as amended at 53 FR 35810, Sept. 15, 1988] § 357.152 Package inserts for anthelmintic drug products. The labeling of the product contains a consumer package insert which includes the following information: (a) A discussion of the symptoms suggestive of pinworm infestation, including a statement that pinworms must be visually identified before taking this medication. (b) A detailed description of how to find and identify the pinworm. (c) A commentary on the life cycle of the pinworm. (d) A commentary on the ways in which pinworms may be spread from person to person and hygienic procedures to follow to avoid such spreading. (e) The appropriate labeling information contained in § 357.150 (Collection of information requirement approved by the Office of Management and Budget under control number 0910-0232) [51 FR 27759, Aug. 1, 1986, as amended at 52 FR 2515, Jan. 23, 1987] § 357.180 Professional labeling. The labeling provided to health professionals (but not to the general public) may contain an additional indication: “For the treatment of common roundworm infestation.” Subpart C—Cholecystokinetic Drug Products § 357.201 Scope. (a) An over-the-counter cholecystokinetic drug product in a form suitable for oral administration is generally recognized as safe and effective and is not misbranded if it meets each of the conditions in this subpart in addition to each of the general conditions established in § 330.1. (b) References in this subpart to regulatory sections of the Code of Federal Regulations are to chapter I of title 21 unless otherwise noted. [48 FR 27005, June 10, 1983] § 357.203 Definition. As used in this subpart: Cholecystokinetic drug product. [48 FR 27005, June 10, 1983] § 357.210 Cholecystokinetic active ingredients. The active ingredient of the product consists of any of the following when used within the specified concentration and dosage form established for each ingredient: (a) 50-percent aqueous emulsion of corn oil. (b) Hydrogenated soybean oil in a suitable, water-dispersible powder. The hydrogenated soybean oil is food-grade, partially hydrogenated with a melting point of 41 to 43.5 °C, an iodine value of 65 to 69, and a fatty acid composition as follows: Fatty acid Percent composition Myristic acid 0.1 Palmitic acid 10.0 Palmitoleic acid 0.1 Stearic acid 13.5 Oleic acid 72.0 Linoleic acid 3.8 Linolenic acid 0.1 Arachidic acid 0.5 Behenic acid 0.2 [54 FR 8321, Feb. 28, 1989] § 357.250 Labeling of cholecystokinetic drug products. (a) Statement of identity. (b) Indications. (c) Warnings. (d) Directions. (1) “Take only when instructed by a doctor:” (2) For products containing 50-percent aqueous emulsion of corn oil. (i) “Shake well before using.” (ii) Oral dosage is 60 milliliters 20 minutes before diagnostic gallbladder x-ray or as directed by a doctor. (3) For products containing hydrogeneated soybean oil. (e) The word “physician” may be substituted for the word “doctor” in any of the labeling statements in this section. [48 FR 27005, June 10, 1983, as amended at 51 FR 16267, May 1, 1986; 52 FR 7830, Mar. 13, 1987; 54 FR 8321, Feb. 28, 1989] § 357.280 Professional labeling. The labeling provided to health professionals (but not to the general public) may contain the following information for ingredients identified in § 357.210: Indication. [54 FR 8321, Feb. 28, 1989] Subparts D-H [Reserved] Subpart I—Deodorant Drug Products for Internal Use Source: 55 FR 19865, May 11, 1990, unless otherwise noted. § 357.801 Scope. (a) An over-the-counter deodorant drug product for internal use in a form suitable for oral administration is generally recognized as safe and effective and is not misbranded if it meets each condition in this subpart and each general condition established in § 330.1 of this chapter. (b) References in this subpart to regulatory sections of the Code of Federal Regulations are to chapter I of title 21 unless otherwise noted. § 357.803 Definitions. As used in this subpart: (a) Colostomy. (b) Deodorant for internal use. (c) Ileostomy. (d) Incontinence. § 357.810 Active ingredients for deodorant drug products for internal use. The active ingredient of the product consists of either of the following when used within the dosage limits established for each ingredient in § 357.850(d): (a) Bismuth subgallate. (b) Chlorophyllin copper complex. § 357.850 Labeling of deodorant drug products for internal use. (a) Statement of identity. (b) Indications. (1) For products containing bismuth subgallate identified in § 357.810(a). (2) For products containing chlorophyllin copper complex identified in § 357.810(b). (ii) “An aid to reduce fecal odor due to incontinence.” (c) Warnings. For products containing chlorophyllin copper complex identified in § 357.810(b). (ii) The warning required by § 330.1(g) of this chapter concerning overdose is not required on products containing chlorophyllin copper complex identified in § 357.810(b). (2) [Reserved] (d) Directions. (1) For products containing bismuth subgallate identified in § 357.810(a). (2) For products containing chlorophyllin copper complex identified in § 357.810(b).