Label: SENNA LAXATIVE- sennosides tablet
- NDC Code(s): 51824-037-01
- Packager: New World Imports
- 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 ingredient (in each tablet)
Sennosides 8.6 mgClose
- relieves occasional constipation (irregularity)
- generally produces a bowel movement in 6 -12 hours
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 use of a laxative. These may indicate a serious condition.
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away.
- take preferably at bedtime or as directed by a doctor
age starting dosage maximum dosage adults and children over 12 years of age or older 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
- each tablet contains: calcium 25 mg
- store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
- Inactive ingredients
croscarmellose sodium, dibasic calcium phosphate dihydrate, hypromellose, liquid paraffin*, magnesium stearate, maltodextrin*, microcrystalline cellulose, mineral oil*, silicon dioxide*, stearic acid*, sodium lauryl sulfate*, talc*, triacetin*
*contains one or more of these ingredientsClose
- Principal Display Panel
Compare to the active ingredient in SENOKOT®†
Natural Vegetable Laxative
Standardized Senna Concentrate
Senna Tablets 8.6 mg each
†This product is not manufactured or distributed by Purdue Products L.P., owner of the registered trademark Senokot®.
NWI, Inc., 160 Athens Way
Nashville, TN 37228
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.Close
- Product Label
NWI Senna Laxative Tablets
- INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51824-037 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX) SENNOSIDES 8.6 mg Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP) HYPROMELLOSES (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) MALTODEXTRIN (UNII: 7CVR7L4A2D) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) MINERAL OIL (UNII: T5L8T28FGP) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STEARIC ACID (UNII: 4ELV7Z65AP) SODIUM LAURYL SULFATE (UNII: 368GB5141J) TALC (UNII: 7SEV7J4R1U) TRIACETIN (UNII: XHX3C3X673) Product Characteristics Color BROWN Score no score Shape ROUND Size 9mm Flavor Imprint Code S3;TCL080;S8 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51824-037-01 100 in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part334 10/30/2013 Labeler - New World Imports (075372276)