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" For the temporary relief of minor aches and pains of arthritis and rheumatism." The qualifying phrase "for the temporary relief of minor aches and pains" should appear with the same degree of prominence and conspicuousness as the phrase "arthritis and... "
The Code of Federal Regulations of the United States of America - Pagina 107
1970
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The Code of Federal Regulations of the United States of America

1989 - 240 pagini
...to reduce the hazard of errors in dosage; (2) By June 1, 1967, manufacturers and distributors of IVi -grain size aspirin tablets discontinue the distribution...salicylate dosage should be appropriately reduced. (g)(l) The label of any drug containing more than 5 percent methyl salicylate (wintergreen oil) should...
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Code of Federal Regulations: 1985-1999

1990 - 198 pagini
...reduce the hazard of errors in dosage; (2) By June 1, 1967, manufacturers and distributors of 1'A-grain size aspirin tablets discontinue the distribution...salicylate dosage should be appropriately reduced. (g)(1) The label of any drug containing more than 5 percent methyl salicylate (wintergreen oil) should...
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The Code of Federal Regulations of the United States of America

1993 - 192 pagini
...flavoring of 5-grain aspirin tablets or other "adult aspirin tablets" be discontinued; and §201.314 (4) Labeling giving undue emphasis to the pleasant...salicylate dosage should be appropriately reduced. (g)(1) The label of any drug containing more than 5 percent methyl salicylate (wintergreen oil) should...
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Code of Federal Regulations: Containing a Codification of Documents of ...

1998 - 196 pagini
...only. If their labeling and advertising clearly offer them for administration to adults only. (e)(1) It is the obligation of the distributor who labels...salicylate dosage should be appropriately reduced. (g)(1) The label of any drug containing more than 5 percent methyl salicylate (wintergreen oi1) should...
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Code of Federal Regulations: Containing a Codification of Documents of ...

1997 - 200 pagini
...only. If their labeling and advertising clearly offer them for administration to adults only. (e)(l) It is the obligation of the distributor who labels...salicylate dosage should be appro-priately reduced. (g)(l) The label of any drug containing more than 5 percent methyl salicylate (wintergreen oil) should...
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Code of Federal Regulations: Containing a Codification of Documents of ...

1981 - 254 pagini
...clearly offered for administration to adults only. (f) If the labeling or advertising of a salictflate preparation offers it for use in arthritis or rheumatism,...salicylate dosage should be appropriately reduced. (g)(1) The label of any drug containing more than 5 percent methyl salicylate (wintergreen oil) should...
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The Code of Federal Regulations of the United States of America

1994 - 196 pagini
...relief of minor aches and pains" should appear with the same degree of prominence and consplcuousness as the phrase "arthritis and rheumatism". The label...salicylate dosage should be appropriately reduced. (g)(l) The label of any drug containing more than 5 percent methyl salicylate (wintergreen oil) should...
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Code of Federal Regulations: Containing a Codification of Documents of ...

1979 - 1056 pagini
...adults only. If offered for use in arthritis or rheumatism, in juxtaposition therewith, the statement: Caution— If pain persists for more than 10 days,...12 years of age, consult a physician immediately. SALICYLATES: METHYL SALICYLATE (WINTERGREEN OIL). See also {{203.303 and 201.314 of this chapter. Warning—Do...
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Code of Federal Regulations: Containing a Codification of Documents of ...

1996 - 1130 pagini
...juxtaposition with directions for use in such conditions, a conspicuous warning statement, such as "Caution: If pain persists for more than 10 days,...12 years of age, consult a physician immediately". (2) Sodium gentisate (sodium-2, 5dihydroxybenzoate) preparations meeting all the following conditions:...
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Code of Federal Regulations: Containing a Codification of Documents of ...

1998 - 1120 pagini
...juxtaposition with directions for use in such conditions, a conspicuous warning statement, such as "Caution: If pain persists for more than 10 days,...12 years of age, consult a physician Im-mediately". (2) Sodium gentisate (sodium-2, 5-dihydroxybenzoate) preparations meet-ing- all the following conditions:...
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