Label: STOOL SOFTENER- docusate sodium capsule, liquid filled
- NDC Code(s): 36800-111-01, 36800-111-06, 36800-111-25
- Packager: TOP CARE (Topco Associates LLC)
- 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 stool softener 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 controlled room temperature 15°-30°C (59°-86°F)
- Inactive ingredients
D&C Red #33, edible ink, FD&C Blue #1, FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol special, and titanium dioxideClose
- Questions or comments?
- Principal Display Panel
SAFE, GENTLE & RELIABLE
Docusate Sodium, 100 mg
COMPARE TO COLACE® active ingreident*
SOFTGELS 100 mg EACH
*This product is not manufactured or distributed by Purdue Products L.P., owner of the registered trademark Colace®.
DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
DISTRIBUTED BY TOPCO ASSOCIATES LLC
ELK GROVE VILLAGE, IL 60007
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.Close
- Package Label
Docusate Sodium 100 mgClose
- INGREDIENTS AND APPEARANCE
docusate sodium capsule, liquid filled
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:36800-111 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 FD&C RED NO. 40 FD&C YELLOW NO. 6 GELATIN GLYCERIN POLYETHYLENE GLYCOLS PROPYLENE GLYCOL SORBITOL D&C RED NO. 33 TITANIUM DIOXIDE FD&C BLUE NO. 1 WATER SORBITAN Product Characteristics Color RED, WHITE Score no score Shape OVAL Size 13mm Flavor Imprint Code P10;51A Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:36800-111-06 1 in 1 BOX 1 60 in 1 BOTTLE 2 NDC:36800-111-01 100 in 1 BOTTLE 3 NDC:36800-111-25 250 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part334 07/01/2010 Labeler - TOP CARE (Topco Associates LLC) (006935977) Registrant - P and L Development of New York Corporation (800014821)