Label: STOOL SOFTENER AND STIMULANT LAXATIVE- docusate sodium and sennosides tablet
- NDC Code(s): 41520-022-01
- Packager: Care One (American Sales Company)
- 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.
Updated August 28, 2013
If you are a consumer or patient please visit this version.
- Active ingredients (in each tablet)
Docusate sodium 50 mg
Sennosides 8.6 mgClose
- for overnight relief from occasional constipation (irregularity)
- generally produces bowel movement in 6 to12 hours
Do not use
- laxative products for longer than 1 week unless told to do so by a doctor
- if you are presently taking mineral oil, unless told to do so by a doctor
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.
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, preferably in the evening, or in divided doses
adults and children 12 years and over
take 2-4 tablets daily children 6 to under 12 years of age take 1-2 tablets daily children 2 to under 6 years of age take up to 1 tablet daily children under 2 ask a doctor
- Other Information
- each tablet contains: calcium 20 mg
- each tablet contains: sodium 6 mg VERY LOW SODIUM
- store at 15º-30ºC (59º-86ºF), protect from excessive moisture
- Inactive ingredients
carnauba wax*, colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake*, hypromellose, magnesium stearate, maltodextrin*, microcrystalline cellulose, polydextrose*, polyethylene glycol*, purified water*, sodium benzoate*, stearic acid, talc*, titanium dioxide, triglycerides*
*contains one or more of these ingredientsClose
- Questions or comments?
Call toll free 1-877-753-3935 Monday-Friday 9AM-5PM ESTClose
- Principal Display Panel
Compare to the Active Ingredients in Peri-Colace®**
STOOL SOFTENER & STIMULANT LAXATIVE
Docusate sodium, 50 mg
Sennosides, 8.6 mg
A GENTLE, PREDICTABLE LAXATIVE
DISTRIBUTED BY FOODHOLD U.S.A., LLC
LANDOVER, MD 20785
©2013 S&S Brands LLC
Quality guaranteed or your money back.
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION
**This product is not manufactured or distributed by Purdue Products L.P., owner of the registered trademark Peri-Colace®Close
- Product Label
Stool softener plus stimulant laxative tablets
- INGREDIENTS AND APPEARANCE
STOOL SOFTENER AND STIMULANT LAXATIVE
docusate sodium and sennosides tablet
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41520-022 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 50 mg SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX) SENNOSIDES 8.6 mg Inactive Ingredients Ingredient Name Strength CARNAUBA WAX (UNII: R12CBM0EIZ) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP) FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) HYPROMELLOSES (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) MALTODEXTRIN (UNII: 7CVR7L4A2D) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) WATER (UNII: 059QF0KO0R) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM BENZOATE (UNII: OJ245FE5EU) STEARIC ACID (UNII: 4ELV7Z65AP) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) ALUMINUM OXIDE (UNII: LMI26O6933) POLYDEXTROSE (UNII: VH2XOU12IE) C10-18 TRIGLYCERIDES (UNII: 43AGM4PHPI) Product Characteristics Color RED Score no score Shape ROUND Size 10mm Flavor Imprint Code TCL97;SS2;S44 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41520-022-01 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 03/01/2013 Labeler - Care One (American Sales Company) (809183973) Registrant - P and L Development of New York Corporation (800014821)