Label: STOOL SOFTENER- docusate sodium capsule, liquid filled
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NDC Code(s):
57896-401-01,
57896-401-03,
57896-401-10,
57896-401-20, view more57896-401-25
- Packager: Geri-Care Pharmaceutical Corp
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated October 19, 2023
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each softgel)
- Purpose
- Uses
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Warnings
Ask a doctor before use if you
• have stomach pain, nausea or vomiting
• have a sudden change in bowel habits that persists over a period of 2 weeks
• are presently taking mineral oil
Stop use and ask a doctor if
• you need to use a laxative longer than 1 week
• you have rectal bleeding or fail to have a bowel movement. These
could be signs of a serious condition.
If pregnant or breast-feeding, ask a health professional before use.
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
- Package Label
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INGREDIENTS AND APPEARANCE
STOOL SOFTENER
docusate sodium capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57896-401 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 FD&C RED NO. 40 (UNII: WZB9127XOA) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) SORBITOL (UNII: 506T60A25R) WATER (UNII: 059QF0KO0R) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) MANNITOL (UNII: 3OWL53L36A) Product Characteristics Color red (reddish) Score no score Shape OVAL Size 12mm Flavor Imprint Code SCU1 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57896-401-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 09/01/2020 2 NDC:57896-401-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 09/01/2020 3 NDC:57896-401-03 30 in 1 BOTTLE; Type 0: Not a Combination Product 09/01/2020 4 NDC:57896-401-20 200 in 1 BOTTLE; Type 0: Not a Combination Product 09/01/2020 5 NDC:57896-401-25 250 in 1 BOTTLE; Type 0: Not a Combination Product 09/20/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M007 01/01/2000 Labeler - Geri-Care Pharmaceutical Corp (611196254) Registrant - Geri-Care Pharmaceutical Corp (611196254)