The Code of Federal Regulations of the United States of AmericaU.S. Government Printing Office, 2001 The Code of Federal Regulations is the codification of the general and permanent rules published in the Federal Register by the executive departments and agencies of the Federal Government. |
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active ingredient adequate advertisement amended appropriate approved Authority citation revised batch beling chapter clinical Code components control number Cosmetic Act Department dispensed distribution dosage form dose Drug Administration drug application Drug Facts drug listing drug prod drug products containing drug sample equipment established name exemption facture Federal Acquisition Regulation Federal Food Federal Register Food and Drug health care entity hexachlorophene human intended labeling maintenance treatment manufac manufacturer manufacturing practice medicated article(s medicated feed Medication Guide ment methadone misbranded name or designation narcotic narcotic drugs National National Drug Code Office oral OTC drug products over-the-counter drug package Packaging and labeling paragraph patient pediatric person Pregnancy Category prescription drug procedures program physician proprietary name quantity quired request safety Service sodium sodium phosphate specific storage Subpart tainer taining tamper-evident testing tion Title treatment program Type A medicated unit
Popular passages
Page 24 - ProHance* should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when ProHance' is administered to a nursing woman.
Page 203 - Advisory Council on Historic Preservation African Development Foundation Federal Acquisition Regulation Agency for International Development, United States Federal Acquisition Regulation Agricultural Marketing Service Agricultural Research Service Agriculture Department Agricultural Marketing Service Agricultural Research Service Animal and Plant Health Inspection Service Chief Financial Officer, Office of Commodity Credit Corporation Cooperative State Research, Education, and Extension Service Economic...
Page 25 - Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Lortab 7.5/500 tablets, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Page 16 - USP) 2.5. 5, and 10 mg contain FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible individuals. Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen In patients who also have aspirin hypersensitivity.
Page 24 - There are. however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed...
Page 26 - Nursing Mothers: It is not known whether this drug is excreted in human milk Because many drugs are excreted in human milk, caution should be exercised when sucralfate is administered to a nursing woman...
Page 51 - Labeling on or within the package from which the drug is to be dispensed bears adequate information for its use, including indications, effects, dosages, routes, methods, and frequency and duration of administration, and any relevant hazards, contraindications, side effects, and precautions...
Page 204 - Community Planning and Development, Office of Assistant Secretary for Community Services, Office of Comptroller of the Currency Construction Industry Collective Bargaining Commission Consumer Product Safety Commission Cooperative State Research, Education, and Extension Service Copyright Office...
Page 54 - Act (1) small open containers of fresh fruits and fresh vegetables and (2) food which is, in accordance with the practice of the trade, to be processed, labeled, or repacked in substantial quantities at establishments other than those where originally processed or packed, on condition that such food is not adulterated or misbranded under the provisions of this Act upon removal from such processing, labeling, or repacking establishment.
Page 199 - IV Federal Maritime Commission (Parts 500 — 599) Title 47 — Telecommunication I Federal Communications Commission (Parts 0 — 199...