国家: 美国
语言: 英文
来源: NLM (National Library of Medicine)
DOCUSATE CALCIUM (UNII: 6K7YS503HC) (DOCUSATE - UNII:M7P27195AG)
Reese Pharmaceutical Co
ORAL
OTC DRUG
Stool Softener - For the relief of occasional constipation. - This product generally produces a bowel movement within 12 to 72 hours. - If you are currently taking mineral oil, unless directed by a doctor. - When abdominal pain, nausea or vomiting are present. - For longer than one week unless directed by a doctor. ■ stomach pain ■ nausea ■ vomiting ■ noticed a sudden change in bowel habits that lasts over 2 weeks - You have rectal bleeding. - You fail to have a bowel movement after use.
OTC monograph not final
PREFERRED STOOL SOFTENER- DOCUSATE CALCIUM CAPSULE, LIQUID FILLED REESE PHARMACEUTICAL CO _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._ ---------- DOCUSATE CALCIUM ACTIVE INGREDIENT Docusate Calcium 240 mg PURPOSE Stool Softener USES For the relief of occasional constipation. This product generally produces a bowel movement within 12 to 72 hours. WARNINGS: DO NOT USE If you are currently taking mineral oil, unless directed by a doctor. When abdominal pain, nausea or vomiting are present. For longer than one week unless directed by a doctor. ASK A DOCTOR BEFORE USE ■ stomach pain ■ nausea ■ vomiting ■ noticed a sudden change in bowel habits that lasts over 2 weeks STOP USE AND ASK A DOCTOR IF You have rectal bleeding. You fail to have a bowel movement after use. IF PREGNANT OR BREAST FEEDING Ask a healthcare professional before use. KEEP OUT OF REACH OF CHILDREN. In case of accidental overdose, get medical help or contact a Poison Control Center (1- 800-222-1222) right away. DIRECTIONS Adults and Children over 12 years of age Take orally 1 softgel daily for 2 to 3 days or until bowl movements are normal, or as directed by a doctor. Children under 12 years of age Do not use this product for children under 12 years of age, unless directed by a doctor. OTHER INFORMATION Store at room temperature between 15ºC to 25ºC (59ºF to 77ºF). Do not use if either seal is broken or missing. INACTIVE INGREDIENTS FD&C Blue #1, FD&C Red #40, Gelatin, Glycerin, Sorbitol Special. QUESTIONS OR COMMENTS PACKAGE/LABEL PRINCIPAL DISPLAY PANEL PREFERRED STOOL SOFTENER docusate calcium capsule, liquid filled PRODUCT INFORMATION PRODUCT TYPE HUMAN OTC DRUG ITEM CODE (SOURCE) NDC:10956-891 ROUTE OF ADMINISTRATION ORAL ACTIVE INGREDIENT/ACTIVE MOIETY Reese Pharmaceutical Co INGREDIENT NAME BASIS OF STRENGTH STRENGTH DOCUSATE CALCIUM (UNII: 6K7YS503HC) (DOCUSATE - UNII:M 阅读完整的文件