The Code of Federal Regulations of the United States of AmericaU.S. Government Printing Office, 2003 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 batch bear beling chapter clinical closures cluding Code components contraindications control number Cosmetic Act Department dispensed distribution distributor of record dosage form Drug Administration drug application Drug Facts drug listing drug prod drug products containing drug sample equipment estab established name exemption facture Federal Food Food and Drug health care entity hexachlorophene human inactive ingredients intended isoproterenol licensed practitioner manufac manufacturer manufacturing practice means medicated article(s medicated feed Medication Guide ment misbranded name of drug name or designation National Drug Code Office oral OTC drug products over-the-counter over-the-counter drug package Packaging and labeling paragraph patients pediatric pernicious anemia person potassium permanganate Pregnancy Category prescription drug proprietary name quired regulations request safety sodium sodium phosphate specific storage studies tablets tainer taining tamper-evident testing tion Type A medicated unit warning statement
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Страница 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...
Страница 25 - ProHance* should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Страница 181 - 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...
Страница 26 - 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.
Страница 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...
Страница 52 - 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...
Страница 163 - XV Office of Administration, Executive Office of the President (Parts 2500—2599) XVI Office of Government Ethics (Parts 2600—2699) XXI Department of the Treasury (Parts 3100—3199...
Страница 164 - LIX National Aeronautics and Space Administration (Part 6901) LX United States Postal Service (Part 7001) LXI National Labor Relations Board (Part 7101...
Страница 65 - The same information concerning the ingredients of the drug as appears on the label and labeling on or within the package from which the drug is to be dispensed...
Страница 163 - Title 1— General Provisions I Administrative Committee of the Federal Register (Parts 1 — 49) II Office of the Federal Register (Parts 50—299) IV Miscellaneous Agencies (Parts 400 — 500) Title 2 [Reserved] Title 3— The President I Executive Office of the President (Parts 100—199) Title 4 — Accounts I General Accounting Office (Parts...