Label: SENNA-S- sennosides and docusate sodium tablet
- NDC Code(s): 70677-1069-1
- Packager: STRATEGIC SOURCING SERVICES LLC
- 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 20, 2023
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- Official Label (Printer Friendly)
- Active ingredient (in each tablet)
- Purpose
- Uses
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Warnings
Do not use
- if you are now 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 or vomiting
- noticed a sudden change in bowel habits that lasts over two weeks
Stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after use of a laxative.
These may indicate a serious condition.If pregnant or breast-feeding, ask a health professional before use.
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Directions
• If taking the starting dosage, take preferably at bedtime; or as directed by a doctor.
• If taking the maximum dosage, take in the morning and at bedtime.Age Starting Dose Maximum Dose 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 2 tablets twice a day children under 2 years ask a doctor ask a doctor - Other information
- Inactive ingredients
- Questions or Comments?
- Package Label
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INGREDIENTS AND APPEARANCE
SENNA-S
sennosides and docusate sodium tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70677-1069 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 CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) HYPROMELLOSES (UNII: 3NXW29V3WO) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TALC (UNII: 7SEV7J4R1U) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) Product Characteristics Color orange Score no score Shape ROUND Size 9mm Flavor Imprint Code PSD22 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70677-1069-1 1 in 1 CARTON 05/01/2023 1 60 in 1 BOTTLE; 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 05/01/2023 Labeler - STRATEGIC SOURCING SERVICES LLC (116956644) Registrant - Geri-Care Pharmaceutical Corp (611196254)