Label: STOOL SOFTENER- docusate sodium capsule
- NDC Code(s): 49348-917-05
- Packager: Mckesson (Sunmark)
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- Active Ingredient (in each softgel)
Docusate Sodium 100 mgClose
- temporary relief of occasional constipation.
- this product generally produces a bowel movement within 12 to 72 hours.
- Warnings - Do not use
- if abdominal pain, nausea or vomiting are present
Ask a doctor before use if
- you notice a sudden change in bowel habits that persists over a period of 2 weeks
- you are presently taking mineral oil
Stop use and ask a doctor if
- rectal bleeding or failure to have a bowel movement occur after use which may indicate a serious condition
- you need to use a laxative for more than 1 week
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away: 1-800-222-1222
- take with a glass of water
adults and children 12 years of age and over take 1 to 3 softgels daily. This dose may be taken as a single daily dose or in divided doses. children 2 to under 12 years of age take 1 softgel daily children under 2 years of age ask a doctor
- Other information
- each softgel contains: sodium 6 mg
- store at controlled room temperature 15o - 30o C (59o- 86o F)
- do not use if imprinted safety seal under cap is broken or missing.
- Inactive Ingredients
edible ink, FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water and sorbitol special.Close
- Principal Display Panel
†Compare to Dulcolax® Stool Softener active ingredient
DOCUSATE SODIUM 100 mg
†This product is not manufactured or distributed by Boehringer Ingelheim Consumer Healthcare, owner of the registered trademark of Dulcolax®.
Another quality product distributed by McKesson
one post street, San Francisco, CA 94104
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Please visit us at www.sunmarkbrand.com
Questions or comments? Call toll free 1-877-753-3935Close
- Product Label
docusate sodium 100 mgClose
- INGREDIENTS AND APPEARANCE
docusate sodium capsule
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49348-917 Route of Administration ORAL DEA Schedule 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) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) Product Characteristics Color ORANGE Score no score Shape OVAL Size 13mm Flavor Imprint Code P51 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49348-917-05 1 in 1 BOX 1 25 in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part334 08/24/2010 Labeler - Mckesson (Sunmark) (177667227)