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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1.–5. rezultāts no 21.
6. lappuse
... directions is within the range regarded as safe for use in self - medication , the single dose is too high for such use unless the release of the drug is sufficiently prolonged . It is obvious that , in filing a new - drug ap- plication ...
... directions is within the range regarded as safe for use in self - medication , the single dose is too high for such use unless the release of the drug is sufficiently prolonged . It is obvious that , in filing a new - drug ap- plication ...
8. lappuse
... directions for use . 201.6 Drugs ; misleading statements . 201.10 Drugs ; statement of ingredients . 201.15 Drugs ; prominence of required label statements . 201.16 Drugs ; Spanish - language version of certain required statements ...
... directions for use . 201.6 Drugs ; misleading statements . 201.10 Drugs ; statement of ingredients . 201.15 Drugs ; prominence of required label statements . 201.16 Drugs ; Spanish - language version of certain required statements ...
11. lappuse
... directions for use . Adequate directions for use means di- rections under which the layman can use a drug safely and for the purposes for which it is intended . ( Section 201.128 defines " intended use . " ) Direc- tions for use may be ...
... directions for use . Adequate directions for use means di- rections under which the layman can use a drug safely and for the purposes for which it is intended . ( Section 201.128 defines " intended use . " ) Direc- tions for use may be ...
32. lappuse
... directions for use of the drug , as required by section 502 ( f ) ( 1 ) of the act and by the regula- tions in this part . ( c ) The statement of identity shall be presented in bold face type on the prin- cipal display panel , shall be ...
... directions for use of the drug , as required by section 502 ( f ) ( 1 ) of the act and by the regula- tions in this part . ( c ) The statement of identity shall be presented in bold face type on the prin- cipal display panel , shall be ...
36. lappuse
... directions to take one tab- let daily may use the term " sodium free " in its labeling . However , when the recommended dose provides for taking more than one dosage unit per day , e.g. , take one or two tablets , or take two tablets ...
... directions to take one tab- let daily may use the term " sodium free " in its labeling . However , when the recommended dose provides for taking more than one dosage unit per day , e.g. , take one or two tablets , or take two tablets ...
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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
Populāri fragmenti
23. lappuse - 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...
23. lappuse - ProHance* should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
45. lappuse - 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.
24. lappuse - 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.
39. lappuse - 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...
156. lappuse - 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...
43. lappuse - 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...
24. lappuse - 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...
24. lappuse - If a patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.
38. lappuse - ... that furnishes or purports to furnish information for use or which prescribes, recommends, or suggests a dosage for the 21 CFR Ch.