Label: STOOL SOFTENER- docusate sodium capsule, liquid filled
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NDC Code(s):
71335-0294-0,
71335-0294-1,
71335-0294-2,
71335-0294-3, view more71335-0294-4, 71335-0294-5, 71335-0294-6, 71335-0294-7, 71335-0294-8, 71335-0294-9
- Packager: Bryant Ranch Prepack
- This is a repackaged label.
- Source NDC Code(s): 57896-401
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 19, 2024
If you are a consumer or patient 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
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HOW SUPPLIED
NDC: 71335-0294-1: 30 Tablets in a BOTTLE
NDC: 71335-0294-2: 100 Tablets in a BOTTLE
NDC: 71335-0294-3: 60 Tablets in a BOTTLE
NDC: 71335-0294-4: 120 Tablets in a BOTTLE
NDC: 71335-0294-5: 90 Tablets in a BOTTLE
NDC: 71335-0294-6: 180 Tablets in a BOTTLE
NDC: 71335-0294-7: 10 Tablets in a BOTTLE
NDC: 71335-0294-8: 28 Tablets in a BOTTLE
NDC: 71335-0294-9: 56 Tablets in a BOTTLE
NDC: 71335-0294-0: 18 Tablets in a BOTTLE
Repackaged/Relabeled by:
Bryant Ranch Prepack, Inc.
Burbank, CA 91504 - PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
STOOL SOFTENER
docusate sodium capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71335-0294(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, UNSPECIFIED (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:71335-0294-1 30 in 1 BOTTLE; Type 0: Not a Combination Product 04/11/2018 2 NDC:71335-0294-2 100 in 1 BOTTLE; Type 0: Not a Combination Product 02/27/2018 3 NDC:71335-0294-3 60 in 1 BOTTLE; Type 0: Not a Combination Product 05/23/2018 4 NDC:71335-0294-4 120 in 1 BOTTLE; Type 0: Not a Combination Product 02/09/2022 5 NDC:71335-0294-5 90 in 1 BOTTLE; Type 0: Not a Combination Product 05/23/2018 6 NDC:71335-0294-6 180 in 1 BOTTLE; Type 0: Not a Combination Product 02/09/2022 7 NDC:71335-0294-7 10 in 1 BOTTLE; Type 0: Not a Combination Product 02/09/2022 8 NDC:71335-0294-8 28 in 1 BOTTLE; Type 0: Not a Combination Product 09/20/2019 9 NDC:71335-0294-9 56 in 1 BOTTLE; Type 0: Not a Combination Product 02/09/2022 10 NDC:71335-0294-0 50 in 1 BOTTLE; Type 0: Not a Combination Product 05/18/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M007 01/01/2000 Labeler - Bryant Ranch Prepack (171714327) Registrant - Bryant Ranch Prepack (171714327) Establishment Name Address ID/FEI Business Operations Bryant Ranch Prepack 171714327 REPACK(71335-0294) , RELABEL(71335-0294)