Label: PLUS PHARMA SENNA STANDARDIZED SENNA CONCENTRATE 8.6 MG SENNOSIDES EACH- sennosides tablet, film coated
Contains inactivated NDC Code(s)
NDC Code(s): 50436-5165-1
- Packager: Unit Dose Services
- 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 March 27, 2006
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each tablet)
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.
- 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
- PLUS PHARMA SENNA STANDARDIZED SENNA CONCENTRATE 8.6 MG SENNOSIDES EACH (SENNOSIDES) TABLET, FILM COATED
INGREDIENTS AND APPEARANCE
PLUS PHARMA SENNA STANDARDIZED SENNA CONCENTRATE 8.6 MG SENNOSIDES EACH
sennosides tablet, film coated
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50436-5165(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) HYPROMELLOSES (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:50436-5165-1 30 in 1 BOTTLE; Type 0: Not a Combination Product 03/27/2006 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 03/27/2006 Labeler - Unit Dose Services (831995316) Registrant - Unit Dose Services (831995316) Establishment Name Address ID/FEI Business Operations Unit Dose Services 831995316 REPACK(50436-5165)