Šalis: Jungtinės Valstijos
kalba: anglų
Šaltinis: NLM (National Library of Medicine)
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)
Liberty Pharmaceuticals, Inc.
ORAL
OTC DRUG
- for the prevention of dry, hard stools - for relief of occasional constipation. - this product generally produces a bowel movement within 12 to 72 hours. - if you are taking mineral oil, unless directed by a doctor - when abdominal pain, nausea, or vomiting are present - for more than 1 week, unless directed by a doctor you notice a sudden change in bowel habits that persists over a period of 2 weeks - you have rectal bleeding - you fail to have a bowel movement after use ask a health professional before use. In case of overdose, get medical help or contact a Poison Control Center right away.
OTC monograph not final
DOK EXTRA STRENGTH STOOL SOFTENER- DOCUSATE SODIUM CAPSULE, LIQUID FILLED LIBERTY PHARMACEUTICALS, 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._ ---------- DRUG FACTS ACTIVE INGREDIENT (IN EACH SOFTGEL) Docusate Sodium 250mg PURPOS E Stool softener US ES for the prevention of dry, hard stools for relief of occasional constipation. this product generally produces a bowel movement within 12 to 72 hours. WARNINGS - DO NOT USE if you are taking mineral oil, unless directed by a doctor when abdominal pain, nausea, or vomiting are present for more than 1 week, unless directed by a doctor ASK A DOCTOR BEFORE USE IF you notice a sudden change in bowel habits that persists over a period of 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 BREASTFEEDING 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 ADULTS AND CHILDREN OVER 12 YEARS OF AGE AND OVER: take 1 softgel daily or as directed by a doctor CHILDREN UNDER 12 YEARS OF AGE: take as directed by a doctor OTHER INFORMATION EACH SOFTGEL CONTAINS sodium 15mg store at controlled room temperature 15 - 30 C (59 - 86 F) do not use if imprinted safety seal under cap is broken or missing o o o o INACTIVE INGREDIENTS edible white ink, FD&C Red No# 40, FD&C Yellow No. 6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified wter, sorbitol special. QUESTIONS OR COMMENTS? Adverse Drug Event Call: (800) 616-2471 PRODUCT LABELING MAJOR DOK™ Docusate Sodium 250 mg Extra Strength Stool Softener For use as a Stool Softener in treating & Avoiding Constipation Distributed by: MAJOR PHARMACEUTICALS 31778 Enterprise Drive Livonia, MI 48150, USA Repackaged By : Aidarex Pharmaceuticals LLC, Corona, CA 92880 DOK EXTRA STRENGTH STOO Perskaitykite visą dokumentą