Label: SENNA-S LAXATIVE- docusate sodium and sennosides tablet
- NDC Code(s): 51824-026-01
- Packager: New World Imports, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- Active ingredients (in each tablet)
Docusate Sodium 50 mg
Sennosides 8.6 mgClose
- relieves occasional constipation (irregularity).
- generally causes bowel movement within 6 to 12 hours.
Do not use:
This product is 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 suddenc hange in bowel movements that persists over 2 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 could be signs of a serious condition.Close
- Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away.Close
- taken preferably at bedtime or as directed by a doctor
Age Starting Dose Maximum Dosage adults and children 12 years of age and older 2 tablets once a day 4 tablets twice a day children 6 to under 12 years of age 1 tablet once a day 2 tablets twice a day children 2 to 6 years of age 1/2 tablet once a day 1 tablet twice a day children under 2 years ask a doctor ask a doctor
- Other information
- each tablet contains: sodium 6 mg/tablet LOW SODIUM
- each tablet contains: calcium 20 mg/tablet
- store at 15°-30°C (59°-86°F),in well closed containers
- do not use if imprinted safety seal under cap is broken or missing
- *This product is not manufactured or distributed by Purdue Pharma L.P., owner of the registered trademark Senokot S.
- Inactive ingredients
carnauba wax*, croscarmellose sodium, DandC Yellow 10 Aluminum Lake, dibasic calcium phosphate dihydrate, FDandC Blue 2 Aluminum Lake*, FDandC Red 40 Aluminum Lake*, FDandC Yellow 6 Aluminum Lake, hypromellose*, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol*, purified water*, sodium benzoate*, stearic acid, titanium dioxideClose
*may also contain
- INGREDIENTS AND APPEARANCE
docusate sodium, sennosides tablet
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51824-026 Route of Administration ORAL DEA Schedule 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 CARNAUBA WAX (UNII: R12CBM0EIZ) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) HYPROMELLOSES (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) POLYVINYL ALCOHOL (UNII: 532B59J990) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color orange Score no score Shape ROUND Size 9mm Flavor Imprint Code TCL081 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51824-026-01 60 in 1 BOTTLE, PLASTIC; 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 12/01/2012 Labeler - New World Imports, Inc. (075372276)