Label: DOCUSATE SODIUM WITH SENNOSIDES- docusate sodium 50mg and sennosides 8.6mg tablet, film coated
- NDC Code(s): 43063-958-01, 43063-958-95
- Packager: PD-Rx Pharmaceuticals, Inc.
- This is a repackaged label.
- Source NDC Code(s): 16103-378
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 3, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients (in each tablet)
- Purpose
- Uses
-
Warnings
Do not use
- laxative products for longer than 1 week unless directed by a doctor
- if you are taking mineral oil, unless directed by a doctor
Ask a doctor before use if you have
- stomach pain
- nausea
- vomiting
- noticed a sudden change in bowel habits that continues over a period of 2 weeks
-
Directions
- take preferably at bedtime or as directed by a doctor
age
starting dosage
maximum dosage
Adults and children 12 years and over
2 tablets once daily
4 tablets twice daily
Children 6 to under 12 years
1 tablet once daily
2 tablets twice daily
Children 2 to under 6 years
1/2 tablet once daily
1 tablet twice daily
Children under 2 years
ask a doctor
ask a doctor
- Other information
- Inactive ingredients
- Questions or comments?
- 16 HOW SUPPLIED/STORAGE AND HANDLING
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
DOCUSATE SODIUM WITH SENNOSIDES
docusate sodium 50mg and sennosides 8.6mg tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43063-958(NDC:16103-378) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX) SENNOSIDES 8.6 mg DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM 50 mg Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) SODIUM BENZOATE (UNII: OJ245FE5EU) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color orange (ORANGE COLOR) Score no score Shape ROUND (ROUND TABLET) Size 10mm Flavor Imprint Code PH32 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43063-958-01 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/21/2019 2 NDC:43063-958-95 1000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/17/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M007 11/05/2018 Labeler - PD-Rx Pharmaceuticals, Inc. (156893695) Registrant - PD-Rx Pharmaceuticals, Inc. (156893695) Establishment Name Address ID/FEI Business Operations PD-Rx Pharmaceuticals, Inc. 156893695 repack(43063-958)