Label: DOCUSATE SODIUM - STOOL SOFTENER LAXATIVE- docusate sodium capsule, liquid filled
- NDC Code(s): 0904-7183-61
- Packager: Major Pharmaceuticals
- 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 July 25, 2023
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
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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.
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Directions
• take softgels 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
MAJOR®
Unit Dose
READ AND KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION
Distributed by:
MAJOR® PHARMACEUTICALS
Livonia, MI 48152
Product of UAE
Packaged and Quality Assured in the USATAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
- Packaging
-
INGREDIENTS AND APPEARANCE
DOCUSATE SODIUM - STOOL SOFTENER LAXATIVE
docusate sodium capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) 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:0904-7183-61 10 in 1 CARTON 09/04/2021 1 10 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 09/04/2021 Labeler - Major Pharmaceuticals (191427277)
