Label: STOOL SOFTENER- docusate sodium capsule, liquid filled
- NDC Code(s): 0363-0351-56
- Packager: WALGREEN CO.
- 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 July 27, 2015
If you are a consumer or patient please visit this version.
- Active ingredient (in each liquid gel)
Docusate sodium 100 mgClose
Stool softener laxativeClose
- 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 (1-800-222-1222) right away.
- take only by mouith. Doses may be taken as a single daily dose or in divided doses.
- take with a glass of water
adults and children
12 years and over
take 1 to 3 liquid gels
children 2 to under
12 years of age
take 1 liquid gel daily children under
2 years of age
ask a doctor
- Other information
- store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
- protect from excessive humidity
- use by expiration date on package
- Inactive ingredients
D&C yellow #10, edible white ink, FD&C red #40, gelatin, glycerine, polyethylene glycol, propylene glycol, sorbitolClose
- Questions or comments?
- Principal display panel
WALGREENS PHARMACIST RECOMMENDEDǂ
Docusate Sodium USP 100 mg
• Gentle & easy relief of occasional constipation
Compare to Dulcolax® Stool Softener Liquid Gels active ingredientǂǂ
ǂWalgreens Pharmacist Survey Study, November 2012.
ǂǂThis product is not manufactured or distributed by Boehringer Ingelheim Pharmaceuticals, Inc., owner of the registered trademark Dulcolax® Stool Softener Liquid Gels.
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
- INGREDIENTS AND APPEARANCE
docusate sodium capsule, liquid filled
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0351 Route of Administration ORAL 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 D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C RED NO. 40 (UNII: WZB9127XOA) GLYCERIN (UNII: PDC6A3C0OX) GELATIN (UNII: 2G86QN327L) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SORBITOL (UNII: 506T60A25R) Product Characteristics Color RED Score no score Shape CAPSULE Size 13mm Flavor Imprint Code A92 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-0351-56 1 in 1 CARTON 1 25 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part334 09/21/1995 07/27/2018 Labeler - WALGREEN CO. (008965063) Establishment Name Address ID/FEI Business Operations Accucaps Industries, Ltd. 248441727 MANUFACTURE(0363-0351) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 PACK(0363-0351)