国家: 美国
语言: 英文
来源: NLM (National Library of Medicine)
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)
BASIC DRUGS, INC.
ORAL
OTC DRUG
Stool Softener Laxative - relieves occasional constipation (irregularity) - generally produces bowel movement in 12 to 72 hours
OTC monograph not final
LAXA-BASIC 100- DOCUSATE SODIUM CAPSULE, LIQUID FILLED BASIC DRUGS, INC. ---------- 401S BASICS ACTIVE INGREDIENT (IN EACH SOFTGEL) Docusate Sodium 100 mg PURPOSE Stool Softener Laxative USES relieves occasional constipation (irregularity) generally produces bowel movement in 12 to 72 hours WARNINGS ASK A DOCTOR BEFORE USE IF YOU • have stomach pain, nausea or vomiting • have a sudden change in bowel habits that persists over a period of 2 weeks • are presently taking mineral oil STOP USE AND ASK A DOCTOR IF • you need to use a laxative longer than 1 week • you have rectal bleeding or fail to have a bowel movement. These could be signs of a serious condition. IF PREGNANT OR BREAST-FEEDING, ask a health professional before use. KEEP OUT OF REACH OF CHILDREN. In case of overdose, get medical help or contact a Poison Control Center right away. DIRECTIONS do not exceed recommended dose Doses may be taken as a single daily dose or in divided doses. Adults and children 12 years and over take 1-3 softgels daily Children 6 to under 12 years of age take 1 softgel daily Children under 6 ask a doctor OTHER INFORMATION • EACH SOFTGEL CONTAINS: sodium 7 mg. Very low sodium • store at 59°-77°F (15°-25°C) • keep tightly closed • TAMPER EVIDENT: Do not use if imprinted seal under cap is missing or broken. INACTIVE INGREDIENTS FD&C red #40, FD&C yellow #6 (sunset yellow), gelatin, glycerin, PEG, sorbitol special, water. PACKAGE LABEL LAXA-BASIC 100 docusate sodium capsule, liquid filled PRODUCT INFORMATION PRODUCT TYPE HUMAN OTC DRUG ITEM CODE (SOURCE) NDC:0761-0434 ROUTE OF ADMINISTRATION ORAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRENGTH DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM 100 mg INACTIVE INGREDIENTS INGREDIENT NAME STRENGTH FD&C RED NO. 40 (UNII: WZB9127XOA) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) BASIC DRUGS, INC. POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) SORBITOL (UNII: 506T60A25R) WATER (UNII: 059QF0KO0R) FD&C YELL 阅读完整的文件