Label: STOOL SOFTENER- docusate calcium capsule, liquid filled
- NDC Code(s): 49348-280-10
- Packager: Mckesson (Sunmark)
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Updated September 24, 2012
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- Active Ingredient (in each softgel)
Docusate Calcium 240 mgClose
For relief of occasional constipation. This product generally produces a bowel movement within 12 to 72 hours.Close
- 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 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.
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
- adults and children over 12 years of age: take 1 softgel daily for several days, or until bowel movements are normal, or as directed by a doctor.
- children under 12 years of age: take as directed by a doctor.
- Other information
- store at controlled room temperature 15o - 30o C (59o- 86o F)
- do not use if imprinted safety seal under cap is broken or missing.
- *This product is not manufactured or distributed by Chattem, Inc., owner of the registered trademark Surfak® Stool Softener.
- Inactive Ingredients
corn oil, D&C Red #33, edible white ink, FD&C Red #40, gelatin, glycerin, purified water and sorbitol special.Close
- Questions or comments?
Call toll free 1-877-753-3935Close
- Principal Display Panel
For gentle relief of constipation
Compare to Surfak® Active Ingredient*
Another quality product distributed by McKesson
one post street, San francisco, CA 94104
Money back gurantee
Please visit us at www.sunmarkbrand.com
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- Product Label
Docusate calcium 240 mgClose
- INGREDIENTS AND APPEARANCE
docusate calcium capsule, liquid filled
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49348-280 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DOCUSATE CALCIUM (UNII: 6K7YS503HC) (DOCUSATE - UNII:M7P27195AG) DOCUSATE CALCIUM 240 mg Inactive Ingredients Ingredient Name Strength CORN OIL (UNII: 8470G57WFM) D&C RED NO. 33 (UNII: 9DBA0SBB0L) FD&C RED NO. 40 (UNII: WZB9127XOA) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) Product Characteristics Color RED Score no score Shape CAPSULE Size 21mm Flavor Imprint Code P58 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49348-280-10 1 in 1 BOX 1 100 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part334 07/09/2010 Labeler - Mckesson (Sunmark) (177667227)