Země: Spojené státy
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)
Olds Softgels Inc.
DOCUSATE SODIUM
DOCUSATE SODIUM 250 mg
ORAL
OTC DRUG
IMPORTANT This is a bulk shipment, intended for further processing only. It is not to be used in its present condition and it should be repackaged immediately and labeled strictly in conformance with the Federal Food, Drug and Cosmetic Act and other pertinent government regulations. Olds SoftGels Inc
OTC monograph not final
DOCUSATE SODIUM 250MG- DOCUSATE SODIUM CAPSULE OLDS SOFTGELS INC. _Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they_ _comply with applicable regulations and policies. FDA has not evaluated whether this product complies._ ---------- ACTIVE INGREDIENT Docusate Sodium 250 mg IMPORTANT This is a bulk shipment, intended for further processing only. It is not to be used in its present condition and it should be repackaged immediately and labeled strictly in conformance with the Federal Food, Drug and Cosmetic Act and other pertinent government regulations. Keep out of reach of children. Olds SoftGels Inc All complaints or claims for allowances of any kind must be made within 10 days after receipt of goods. All complaints or claims for allowances of any kind must be made within 10 days after receipt of goods. INACTIVE INGREDIENTS Red No. 40 Granular FD and C Yellow No.6 Granular Gelatin Glycerin USP 99 Percent Polyethylene Glycol 400 USP PEG 400 Propylene glycol Purified water Sorbitol special GC PACKAGE LABEL DOCUSATE SODIUM 250MG docusate sodium capsule PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:6 9 16 0 -0 0 3 ROUTE OF ADMINISTRATION ORAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRE NG TH DO CUSATE SO DIUM (UNII: F0 5Q2T2JA0 ) (DOCUSATE - UNII:M7P2719 5AG) DOCUSATE SODIUM 250 mg INACTIVE INGREDIENTS INGREDIENT NAME STRE NG TH PO LYETHYLENE GLYCO L 4 0 0 (UNII: B6 9 78 9 4SGQ) PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3) GELATIN (UNII: 2G8 6 QN327L) GLYCERIN (UNII: PDC6 A3C0 OX) WATER (UNII: 0 59 QF0 KO0 R) SO RBITAN (UNII: 6 O9 2ICV9 RU) SO RBITO L (UNII: 50 6 T6 0 A25R) FD&C RED NO . 4 0 (UNII: WZB9 127XOA) FD&C YELLO W NO . 6 (UNII: H77VEI9 3A8 ) PRODUCT CHARACTERISTICS COLOR red (40 ) , yello w (6 ) S CORE no sco re S HAP E OVAL S IZ E 23mm FLAVOR IMPRINT CODE GC425 CONTAINS PACKAG ING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:6 9 16 0 -0 0 3-0 1 70 0 0 in 1 BOX; Type 0 : No Přečtěte si celý dokument