Label: STOOL SOFTENER DOCUSATE SODIUM- docusate sodium capsule, gelatin coated
- NDC Code(s): 54257-902-06
- Packager: Magno-Humphries, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 27, 2023
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- Official Label (Printer Friendly)
- MHL NDC 54257-902-06
- DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED
- Active ingredient (in each softgel)
- Purpose
- Uses
-
Warnings
Do not use
Ask a doctor before use if you have
Stop use and ask a doctor if
ask a health professional before use. If pregnant or breast-feeding,
- if you are presently taking mineral oil, unless told by a doctor
- stomach pain
- nausea
- vomiting
- noticed a sudden change in bowel movements that continues over a period of 2 weeks
- you have rectal bleeding or you fail to have a bowel movement after use of a laxative. These could be signs of a serious condition.
- you need to use a stool softener for mroe than 1 week.
-
Directions
- Take only by mouth. This dose may be taken as a single daily dose or in divided doses.
- take 1-3 softgels daily or as directed by a doctor adults and children over 12 years of age:
- take 1 softgel daily or as directed by a doctor children 2 to under 12 years of age:
- ask a doctor children under 2 years of age:
- Other information
- Inactive ingredients
- Questions?
- *This product is not manufactured or distributed by the owner of the registered trademark Colace®. Distributed by: Magno-Humphries, Inc. OR 97223 U.S.A. Visit our website: www.magno-humphries.com
- Package Labeling:
-
INGREDIENTS AND APPEARANCE
STOOL SOFTENER DOCUSATE SODIUM
docusate sodium capsule, gelatin coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54257-902 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 GELATIN, UNSPECIFIED (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) Product Characteristics Color red 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:54257-902-06 1000 in 1 BOTTLE; Type 0: Not a Combination Product 04/04/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M007 04/04/2017 Labeler - Magno-Humphries, Inc. (063251433)
