Label: DOCUSATE SODIUM capsule, liquid filled
- NDC Code(s): 55154-2340-0
- Packager: Cardinal Health 107, LLC
- This is a repackaged label.
- Source NDC Code(s): 0904-7115
- 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.
Drug Label Information
Updated January 13, 2023
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 liquid-filled capsule)
- Purpose
- Uses
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Warnings
Ask a doctor before use if you have
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- stomach pain
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- nausea
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- vomiting
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- noticed a sudden change in bowel habits that lasts over 2 weeks
- Directions
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Other information
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each capsule contains: sodium 8 mg
Very Low Sodium
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- store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
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- protect from light, heat and moisture
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- TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
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- see end flap for expiration date and lot number
- Inactive ingredients
- Questions or comments?
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
DOCUSATE SODIUM
docusate sodium capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55154-2340(NDC:0904-7115) 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) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) GELATIN, UNSPECIFIED (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) ISOPROPYL ALCOHOL (UNII: ND2M416302) LIGHT MINERAL OIL (UNII: N6K5787QVP) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) SORBITAN (UNII: 6O92ICV9RU) Product Characteristics Color red Score no score Shape OVAL Size 12mm Flavor Imprint Code 752 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55154-2340-0 10 in 1 BAG 04/16/2021 1 1 in 1 BLISTER PACK; 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 04/16/2021 Labeler - Cardinal Health 107, LLC (118546603) Establishment Name Address ID/FEI Business Operations Aphena Pharma Solutions - Tennessee, LLC 118348161 REPACK(55154-2340)