Label: SENNA S- sennosides and docusate sodium tablet, coated
- NDC Code(s): 53329-989-62
- Packager: Medline Industries, LP
- 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 December 15, 2022
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each tablet)
- Purpose
- Uses
-
Warnings
Do not use
- this product if you are presently taking mineral oil, unless directed by a doctor
- laxative products for longer than 1 week unless directed by a doctor
Ask a doctor before use if you have
- stomach pain
- nausea
- vomiting
- a sudden change in bowel movements that persists over 2 weeks
-
Directions
- take preferably at bedtime or as directed by a doctor
- if you do not have a comfortable bowel movement by the second day, increase dose by one tablet (do not exceed maximum dosage) or decrease dose until you are comfortable
age
starting
dosage
maximum
dosage
adults and children 12
years of age and over
2 tablets
once a day
4 tablets
twice a day
children 6 to
under 12 years
1 tablet
once a day
2 tablets
twice a day
children 2 to
under 6 years
1/2 tablet
once a day
1 tablet
twice a day
children under 2 years
ask a doctor
ask a doctor
- Other information
- Inactive ingredients
- Questions or comments?
- Manufacturing Information
- Package Label
-
INGREDIENTS AND APPEARANCE
SENNA S
sennosides and docusate sodium tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53329-989 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM 50 mg SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX) SENNOSIDES 8.6 mg Inactive Ingredients Ingredient Name Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) CARNAUBA WAX (UNII: R12CBM0EIZ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) SODIUM BENZOATE (UNII: OJ245FE5EU) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color orange Score score with uneven pieces Shape ROUND Size 10mm Flavor Imprint Code TCL;081 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53329-989-62 60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/22/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 05/22/2018 Labeler - Medline Industries, LP (025460908) Registrant - Medline Industries, LP (025460908)