Label: DOCUSATE SODIUM capsule, liquid filled
- NDC Code(s): 0904-7115-61
- 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 April 19, 2022
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
-
Warnings
Ask a doctor before use if you have
- stomach pain
- nausea
- vomiting
- noticed a sudden change in bowel habits that lasts over 2 weeks
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
-
Principal Display Panel
MAJOR®
NDC 0904-7115-61
Unit Dose
Docusate Sodium
Stool Softener Laxative
100 mgThis Unit Dose package is not child resistant and is Intended for Institutional Use Only.
100 Softgels
50844 ORG112075212
Distributed by:
MAJOR® PHARMACEUTICALS
Livonia, MI 48152Product of Dubai
Packaged and Quality Assured in the USARev. 02/21 M-17 Re-order No. 701287
Major 44-752
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INGREDIENTS AND APPEARANCE
DOCUSATE SODIUM
docusate sodium capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) 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 (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 (clear) 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:0904-7115-61 10 in 1 CARTON 04/16/2021 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 04/16/2021 Labeler - Major Pharmaceuticals (191427277) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 pack(0904-7115) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867837 pack(0904-7115) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 967626305 pack(0904-7115)