[Code of Federal Regulations] [Title 21, Volume 5] [Revised as of April 1, 2001] From the U.S. Government Printing Office via GPO Access [CITE: 21CFR336.50] [Page 232-233] TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES--Continued PART 336--ANTIEMETIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE--Table of Contents Subpart C--Labeling Sec. 336.50 Labeling of antiemetic drug products. (a) Statement of identity. The labeling of the product contains the established name of the drug, if any, and identifies the product as an ``antiemetic.'' (b) Indications. The labeling of the product states the following under the heading ``Indications,'' ``For the prevention and treatment of the nausea, vomiting, or dizziness associated with motion sickness.'' Other truthful and nonmisleading statements, describing only the indications for use that have been established and listed in this paragraph (b), may also be 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) For products containing any ingredient identified in Sec. 336.10--(i) When labeled for use in adults and for those products that can be and are labeled for use in children under 12 years of age. ``Do not take this product, unless directed by a doctor, if you have a breathing problem such as emphysema or chronic bronchitis, or if you have glaucoma or difficulty in urination due to enlargement of the prostate gland.'' (ii) For those products that can be and are labeled only for children under 12 years of age. ``Do not give this product to children who have a breathing problem such as chronic bronchitis or who have glaucoma, without first consulting the child's doctor.'' (2) For products containing cyclizine hydrochloride identified in Sec. 336.10(a). ``Do not give to children under 6 years of age unless directed by a doctor.'' (3) For products containing dimenhydrinate identified in Sec. 336.10(b). ``Do not give to children under 2 years of age unless directed by a doctor.'' (4) For products containing diphenhydramine hydrochloride identified in Sec. 336.10(c). ``Do not give to children under 6 years of age unless directed by a doctor.'' (5) For products containing meclizine hydrochloride identified in Sec. 336.10(d). ``Do not give to children under 12 years of age unless directed by a doctor.'' (6) For products containing cyclizine hydrochloride identified in Sec. 336.10(a) or meclizine hydrochloride identified in Sec. 330.10(d). ``May cause drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect. Avoid alcoholic beverages while taking this product. Do not take this product if you are taking sedatives or tranquilizers, without first consulting your doctor. Use caution when driving a [[Page 233]] motor vehicle or operating machinery.'' (7) For products containing dimenhydrinate identified in Sec. 336.10(b) or diphenhydramine hydrochloride identified in Sec. 336.10(c). ``May cause marked drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect. Avoid alcoholic beverages while taking this product. Do not take this product if you are taking sedatives or tranquilizers, without first consulting your doctor. Use caution when driving a motor vehicle or operating machinery.'' (d) Directions. The labeling of the product contains the following information under the heading ``Directions'': (1) For products containing cyclizine hydrochloride identified in Sec. 336.10(a). Adults and children 12 years of age and over: Oral dosage is 50 milligrams every 4 to 6 hours, not to exceed 200 milligrams in 24 hours, or as directed by a doctor. Children 6 to under 12 years of age: Oral dosage is 25 milligrams every 6 to 8 hours, not to exceed 75 milligrams in 24 hours, or as directed by a doctor. (2) For products containing dimenhydrinate identified in Sec. 336.10(b). Adults and children 12 years of age and over: Oral dosage is 50 to 100 milligrams every 4 to 6 hours, not to exceed 400 milligrams in 24 hours, or as directed by a doctor. Children 6 to under 12 years of age: Oral dosage is 25 to 50 milligrams every 6 to 8 hours, not to exceed 150 milligrams in 24 hours, or as directed by a doctor. Children 2 to under 6 years of age: Oral dosage is 12.5 to 25 milligrams every 6 to 8 hours, not to exceed 75 milligrams in 24 hours, or as directed by a doctor. (3) For products containing diphenhydramine hydrochloride identified in Sec. 336.10(c). Adults and children 12 years of age and over: Oral dosage is 25 to 50 milligrams every 4 to 6 hours, not to exceed 300 milligrams in 24 hours, or as directed by a doctor. Children 6 to under 12 years of age: Oral dosage is 12.5 to 25 milligrams every 4 to 6 hours, not to exceed 150 milligrams in 24 hours, or as directed by a doctor. (4) For products containing meclizine hydrochloride identified in Sec. 336.10(d). Adults and children 12 years of age and over: Oral dosage is 25 to 50 milligrams once daily, or as directed by a doctor. (e) The word ``physician'' may be substituted for the word ``doctor'' in any of the labeling statements in this section. [52 FR 15892, Apr. 30, 1987, as amended at 53 FR 35809, Sept. 15, 1988; 59 FR 16982, Apr. 11, 1994]