Label: SENNA STANDARDIZED SENNA CONCENTRATE 8.6 MG SENNOSIDES EACH- sennosides tablet, film coated
- NDC Code(s): 45865-974-30, 45865-974-60
- Packager: medsource pharmaceuticals
- This is a repackaged label.
- Source NDC Code(s): 51645-851
- Category: HUMAN OTC DRUG LABEL
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 30, 2019
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- Official Label (Printer Friendly)
- Active ingredient (in each tablet)
- Purpose
- Uses
- Warnings
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Directions
- take preferably at bedtime or as directed by a doctor
age starting dosage 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 under 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
- Inactive ingredients
- Questions?
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
SENNA STANDARDIZED SENNA CONCENTRATE 8.6 MG SENNOSIDES EACH
sennosides tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:45865-974(NDC:51645-851) Route of Administration ORAL 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 CALCIUM CARBONATE (UNII: H0G9379FGK) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) SODIUM SULFATE (UNII: 0YPR65R21J) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) MALTODEXTRIN (UNII: 7CVR7L4A2D) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STEARIC ACID (UNII: 4ELV7Z65AP) TRIACETIN (UNII: XHX3C3X673) Product Characteristics Color brown Score 2 pieces Shape ROUND (Biconvex) Size 9mm Flavor Imprint Code GPI;W2 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:45865-974-30 30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/11/2019 2 NDC:45865-974-60 60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/11/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 03/27/2006 Labeler - medsource pharmaceuticals (833685915) Establishment Name Address ID/FEI Business Operations medsource pharmaceuticals 833685915 repack(45865-974)