Label: STOOL SOFTENER- docusate sodium capsule, liquid filled
- NDC Code(s): 63981-110-40
- Packager: Costco Wholesale
- 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
- relieves occasional constipation (irregularity)
- generally produces bowel movement in 12 to 72 hours
Ask a doctor before use if you have
- stomach pain
- noticed a sudden change in bowel habits that lasts over 2 weeks
Stop use and ask a doctor if
- you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of 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.
- take only by mouth. 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 2 to under 12 years of age take 1 softgel daily children under 2 years ask a doctor
- Other information
- each softgel contains: sodium 6 mg
- store at 25ºC (77ºF); excursions permitted between 15-30ºC (59-86ºF)
- Inactive ingredients
D&C red #33*, D&C yellow #10*, edible ink, FD&C blue #1*, FD&C red #40, FD&C yellow #6, gelatin, glycerin, lecithin*, medium-chain triglycerides*, polyethylene glycol, propylene glycol*, purified water, sorbitan, sorbitol, titanium dioxide
*contains one or more of these ingredientsClose
- Questions or comments?
Call 1-877-753-3935 Monday-Friday 9AM-5PM ESTClose
- Principal Display Panel
COMPARE TO THE COLACE® ACTIVE INGREDIENT †
Docusate Sodium, 100 mg
Gentle, Effective relief
Stimulant-Free for comfortable relief
†This product is not manufactured or distributed by Purdue Products L.P., owner of the registered trademark Colace®.
Distributed by: PL Developments
Westbury, NY 11590 U.S.A 1-877-753-3935
For: Costco Wholesale Corporation
P.O. Box 34535, Seattle, WA 98124-1535
USA 1-800-774-2678 www.costco.com
Product of USA
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.Close
- Product Labeling
Docusate sodium 100 mg softgels
- INGREDIENTS AND APPEARANCE
docusate sodium capsule, liquid filled
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:63981-110 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM 100 mg Inactive Ingredients Ingredient Name Strength D&C RED NO. 33 D&C YELLOW NO. 10 FD&C BLUE NO. 1 FD&C RED NO. 40 FD&C YELLOW NO. 6 GELATIN GLYCERIN EGG PHOSPHOLIPIDS MEDIUM-CHAIN TRIGLYCERIDES POLYETHYLENE GLYCOLS PROPYLENE GLYCOL WATER SORBITAN SORBITOL TITANIUM DIOXIDE Product Characteristics Color RED, WHITE Score no score Shape OVAL Size 12mm Flavor Imprint Code P10;S78;SCU2 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63981-110-40 400 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part334 07/30/2013 Labeler - Costco Wholesale (103391843)