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Drug labeling; sodium labeling for over-the-counter drugs. Final rule.
Fed Regist. 2004 Nov 29; 69(228):69278-80.FR

Abstract

The Food and Drug Administration (FDA) is issuing a final rule amending the regulations for sodium labeling for over-the-counter (OTC) drug products by extending the sodium content labeling requirement to rectal drug products containing sodium phosphate/sodium biphosphate (sodium phosphates). FDA is taking this action because people with certain medical conditions are at risk for an electrolyte imbalance to occur when using rectal sodium phosphates products. Serious adverse events and deaths have occurred because of the high level of sodium present in these products. This final rule is part of FDA's ongoing review of OTC drug products.

Authors

No affiliation info available

Pub Type(s)

Journal Article

Language

eng

PubMed ID

15570675

Citation

Food and Drug Administration, HHS. "Drug Labeling; Sodium Labeling for Over-the-counter Drugs. Final Rule." Federal Register, vol. 69, no. 228, 2004, pp. 69278-80.
Food and Drug Administration, HHS. Drug labeling; sodium labeling for over-the-counter drugs. Final rule. Fed Regist. 2004;69(228):69278-80.
Food and Drug Administration, HHS. (2004). Drug labeling; sodium labeling for over-the-counter drugs. Final rule. Federal Register, 69(228), 69278-80.
Food and Drug Administration, HHS. Drug Labeling; Sodium Labeling for Over-the-counter Drugs. Final Rule. Fed Regist. 2004 Nov 29;69(228):69278-80. PubMed PMID: 15570675.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Drug labeling; sodium labeling for over-the-counter drugs. Final rule. A1 - ,, PY - 2004/12/2/pubmed PY - 2004/12/16/medline PY - 2004/12/2/entrez SP - 69278 EP - 80 JF - Federal register JO - Fed Regist VL - 69 IS - 228 N2 - The Food and Drug Administration (FDA) is issuing a final rule amending the regulations for sodium labeling for over-the-counter (OTC) drug products by extending the sodium content labeling requirement to rectal drug products containing sodium phosphate/sodium biphosphate (sodium phosphates). FDA is taking this action because people with certain medical conditions are at risk for an electrolyte imbalance to occur when using rectal sodium phosphates products. Serious adverse events and deaths have occurred because of the high level of sodium present in these products. This final rule is part of FDA's ongoing review of OTC drug products. SN - 0097-6326 UR - https://www.unboundmedicine.com/medline/citation/15570675/Drug_labeling L2 - https://medlineplus.gov/overthecountermedicines.html DB - PRIME DP - Unbound Medicine ER -