[Code of Federal Regulations] [Title 21 Volume 5] [Revised as of April 1, 2003] From the U.S. Government Printing Office via GPO Access [CITE: 21CFR369.21] [Page 310-312] TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) PART 369--INTERPRETATIVE STATEMENTS RE WARNINGS ON DRUGS AND DEVICES FOR OVER-THE-COUNTER SALE--Table of Contents Subpart B--Warning and Caution Statements for Drugs Sec. 369.21 Drugs; warning and caution statements required by regulations. ACETAMINOPHEN (N-ACETYL-p-AMINOPHENOL) (See Sec. 310.201(a)(1) of this chapter.) Warning--Do not give to children under 3 years of age or use for more than 10 days unless directed by a physician. If offered for use in arthritis, or rheumatism, in juxtaposition therewith, the statement: Caution--If pain persists for more than 10 days, or redness is present, or in conditions affecting children under 12 years of age consult a physician immediately. ALCOHOL RUBBING COMPOUND. (See 26 CFR 182.855(a)(5); The National Formulary, Tenth Edition 1955, pp. 27-28; and section 502(g) of the act). Warning--For external use only. If taken internally serious gastric distrubances will result. ANTIHISTAMINICS, ORAL (PHENYLTOLOXAMINE DIHYDROGEN CITRATE AND CHLOROTHEN CITRATE PREPARATIONS). (See Sec. 310.201(a)(4) and (a)(24) of this chapter.) Caution--This preparation may cause drowsiness. Do not drive or operate machinery while taking this medication. Do not give to children under 6 years of age or exceed the recommended dosage unless directed by physician. If offered for symptoms of colds, the statement: Caution--If relief does not occur within 3 days, discontinue use and consult physician. CARBETAPENTANE CITRATE PREPARATIONS. (See Cough-Due-to-Cold Preparations.) ``COUGH-DUE-TO-COLD'' PREPARATIONS (CARBETAPENTANE CITRATE). (See Sec. 310.201(a)(20) of this chapter.) ``Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.'' DICYCLOMINE HYDROCHLORIDE WITH AN ANTACID. (See Sec. 310.201(a)(8) of this chapter.) Warning--Do not exceed the recommended dosage. Do not administer to children under 12 years of age or use for a prolonged period unless directed by physician, since persistent or recurring symptoms may indicate a serious disease requiring medical attention. [[Page 311]] DIPHEMANIL METHYLSULFATE FOR EXTERNAL USE. (See Sec. 310.201(a)(22) of this chapter.) Caution--If redness, irritation, swelling, or pain persists or increases, discontinue use and consult physician. DRUGS IN DISPENSERS PRESSURIZED BY GASEOUS PROPELLANTS. (See also Sec. 310.201(a) (11) and (18) of this chapter.) The warnings herein shall appear prominently and conspicuously, but in no case may the letters be less than \1/16\ inch in height. If the label of any package is too small to accommodate the warnings, the Commissioner may establish by regulation an acceptable alternative method, e.g., a type size smaller than \1/16\ inch in height. A petition requesting such a regulation, as an amendment to this paragraph, shall be submitted to the Dockets Management Branch in the form established in part 10 of this chapter. Warning--Avoid spraying in eyes. Contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120 deg. F. Keep out of reach of children. In the case of products packaged in glass containers, the word ``break'' may be substituted for the word ``puncture.'' The words ``Avoid spraying in eyes'' may be deleted from the warning in the case of a product not expelled as a spray, or that is intended to be used in the eyes. In addition to the above warning, the label of a drug packaged in a self-pressurized container in which the propellant consists in whole or in part of a halocarbon or hydrocarbon shall bear the following warning: Warning--Use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal. The warning is not required for the following products: (a) Products expelled in the form of a foam or cream, which contain less than ten percent propellant in the container; (b) Products in a container with a physical barrier that prevents escape of the propellant at the time of use; (c) Products of a net quantity of contents of less than 2 ozs. that are designed to release a measured amount of product with each valve actuation; (d) Products of a net quantity of contents of less than \1/2\ oz. DYCLONINE HYDROCHLORIDE. (See Sec. 310.201(a)(23) of this chapter.) Caution--Do not use in the eyes. Not for prolonged use. Do not apply to large areas of the body. If redness, irritation, swelling, or pain persists or increases, discontinue use unless directed by physician. Do not use, but consult physician for deep or puncture wounds or serious burns. Do not use in case of rectal bleeding, as this may indicate serious disease. HEXADENOL. (See Sec. 310.201(a)(11) of this chapter.) Caution--Do not use for treatment of serious burns or skin conditions or for conditions which persist for prolonged periods. In such cases, consult your physician. Do not spray in vicinity of eyes, mouth, nose, or ears. Do not store above 120 deg. F. IPECAC SYRUP IN ONE-FLUID OUNCE CONTAINERS FOR EMERGENCY TREATMENT OF POISONING, TO INDUCE VOMITING. (See Sec. 201.308 of this chapter.) Ipecac syrup packaged for over-the-counter sale must bear statements to the following effect, in a prominent and conspicuous manner: The following statement (boxed and in red letters): ``For emergency use to cause vomiting in poisoning. Before using, call physician, the Poison Control Center, or hospital emergency room immediately for advice.'' The following warning: Warning--Keep out of reach of children. Do not use in unconscious persons. Ordinarily, this drug should not be used if strychnine, corrosives such as alkalies (lye) and strong acids, or petroleum distillates such as kerosene, gasoline, coal oil, fuel oil, paint thinner, or cleaning fluid have been ingested. ISOAMYLHYRDOCUPREINE AND ZOLAMINE HYDROCHLORIDE RECTAL PREPARATIONS FOR EXTERNAL USE (See Sec. 310.201(a)(3) of this chapter.) [[Page 312]] Warning--Do not use this preparation in case of rectal bleeding, as this may indicate serious disease. NEOMYCIN SULFATE WITH A VASOCONSTRICTOR, IN NASAL PREPARATIONS (SPRAY OR DROPS). Caution--Do not exceed recommended dosage. Do not administer to children under 3 years of age unless directed by physician. PRAMOXINE HYDROCHLORIDE FOR EXTERNAL USE. (See Sec. 310.201(a)(19) of this chapter.) Caution--Do not use in the eyes or nose. Not for prolonged use. Do not apply to large areas of the body. If redness, irritation, swelling, or pain persists or increases, discontinue use unless directed by a physician. SODIUM GENTISATE. (See Secs. 201.314 and 310.301(a)(2) of this chapter.) Warning--Do not use in children under 6 years of age or use for prolonged period unless directed by physician. ``Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.'' If offered for use in arthritis or rheumatism, in juxtaposition therewith, the statement: Caution--If pain persists for more than 10 days, or redness is present, or in conditions affecting children under 12 years of age, consult a physician immediately. TUAMINOHEPTANE SULFATE NASAL PREPARATIONS. (See Sec. 310.201(a)(16) of this chapter.) Caution--Do not exceed recommended dosage. Overdosage may cause nervousness, restlessness, or sleeplessness. Individuals with high blood pressure, heart disease, diabetes, or thyroid disease should use only as directed by physician. Do not use for more than 3 or 4 consecutive days unless directed by physician. VIBESATE PREPARATIONS. (See Sec. 310.201(a)(18) of this chapter.) Caution--Do not use but consult physician for deep or puncture wounds or serious burns. If redness, irritation, swelling, or pain persists or increases, discontinue use and consult physician. Warning--Contents under pressure. Do not puncture. Do not use or store near heat or open flame. Exposure to temperatures above 130 deg. Fahrenheit may cause bursting. Never throw container into fire or incinerator. [39 FR 11745, Mar. 29, 1974] Editorial Note: For Federal Register citations affecting Sec. 369.21, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and on GPO Access.