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
- 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.
Updated August 27, 2020
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- Active Ingredients (in each tablet)
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
- noticed a sudden change in bowel habits that continues over a period of 2 weeks
Stop use and ask a doctor if
you have rectal bleeding or fail to have a bowel movement after the use of a laxative. These may indicate a serious condition.
- take preferably at bedtime or as directed by a doctor
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 coated
Product 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 not final part334 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)