Label: DOCUSATE SODIUM - STOOL SOFTENER LAXATIVE- docusate sodium capsule, liquid filled
- NDC Code(s): 55154-3369-0
- Packager: Cardinal Health 107, LLC
- This is a repackaged label.
- Source NDC Code(s): 0904-7183
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 9, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient (in each softgel)
- Purpose
- Uses
-
Warnings
Ask a doctor before use if you have
• abdominal pain, nausea, or vomiting
• a sudden change in bowel habits that lasts over 14 daysAsk a doctor or pharmacist before use if you are presently taking mineral oil
Stop use and ask a doctor if
• you have rectal bleeding or no bowel movement after using this product.
These can be signs of a serious condition
• you need to use a laxative for more than 1 weekIf pregnant or breast-feeding, ask a health care professional before use.
This unit dose package is not child resistant and is Intended for Institutional Use Only.
Keep out of reach of children
Overdose Warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms. -
Directions
• take softgel with a full glass (8 oz) of water
adults and children 12 years of age and older
take 1 to 3 softgels daily or as directed
by a doctor. This dose may be taken as a single daily dose or in divided doses.children 6 to under 12 years of age
take 1 softgel daily or as directed by a doctor
children under 6 years of age
ask a doctor
- Other information
- Inactive ingredients
- Questions or comments?
-
SPL UNCLASSIFIED SECTION
Distributed by:
MAJOR® PHARMACEUTICALS
Livonia, MI 48152
Distributed By:
Cardinal Health
Dublin, OH 43017
L57466800124
Product of UAE
Packaged and Quality Assured in the USATAMPER EVIDENT: DO NOT USE IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
READ FOR COMPLETE WARNINGS AND PRODUCT INFORMATION
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INGREDIENTS AND APPEARANCE
DOCUSATE SODIUM - STOOL SOFTENER LAXATIVE
docusate sodium capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55154-3369(NDC:0904-7183) 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 777 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55154-3369-0 10 in 1 BAG 09/04/2021 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 Drug M007 09/04/2021 Labeler - Cardinal Health 107, LLC (118546603)
