Code of Federal Regulations: Containing a Codification of Documents of General Applicability and Future Effect as of December 31, 1948, with Ancillaries and IndexDivision of the Federal Register, the National Archives, 1997 Special edition of the Federal Register, containing a codification of documents of general applicability and future effect ... with ancillaries. |
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active ingredient adequate advertisement Agency amended animal appropriate approved Authority citation batch beling chapter clinical closures Code Commission components contraindications control number Cosmetic Act Department detoxification distribution distributor dosage form dose Drug Administration drug application drug listing drug product containers equipment established name evaluation exemption Federal Acquisition Regulation Federal Food Federal Register Food and Drug gram Health hexachlorophene human intended licensed maintenance treatment manufac manufacture manufacturing practice medicated article(s medicated feed ment methadone misbranded name or designation narcotic narcotic drugs National National Drug Code new-drug Office operations oral over-the-counter drug package Packaging and labeling paragraph patient patient's record pediatric pernicious anemia person pregnancy Pregnancy Category prescription drugs processing program physician proprietary name quired safety sample Service shipment specific storage submitted Subpart SUBTITLE tained tainer testing tion treatment program Type A medicated ucts unit warning statement
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Страница 23 - 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 23 - ProHance* should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Страница 45 - Indications Based on a review of this drug by the National Academy of Sciences— National Research Council and/or other information, FDA has classified the indications as follows: Effective: For the management of the manifestations of psychotic disorders.
Страница 24 - 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 39 - 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 156 - Overseas Private Investment Corporation (Part 4301) XXXV Office of Personnel Management (Part 4501) XL Interstate Commerce Commission (Part 5001) XLI Commodity Futures Trading Commission (Part 5101...
Страница 43 - REGULATIONS MAKING EXEMPTIONS SEC. 405. The Secretary shall promulgate regulations exempting from any labeling requirement of this 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...
Страница 24 - 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 24 - If a patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.
Страница 38 - ... that furnishes or purports to furnish information for use or which prescribes, recommends, or suggests a dosage for the 21 CFR Ch.