Label: GERI-KOT- standardized senna concentrate tablet
- NDC Code(s): 53808-1110-1
- Packager: DOH CENTRAL PHARMACY
- This is a repackaged label.
- Source NDC Code(s): 57896-451
- 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 January 17, 2019
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each tablet)
Do not use for more than 1 week unless directed by a doctor.
Ask a doctor before use if you
• have abdominal pain, nausea or vomiting
• have noticed a sudden change in bowel habits that lasts over 2 weeks
Stop use and ask a doctor if
• you have no bowel movement within 12 hours
• you have rectal bleeding
These could be signs of a serious condition.
If pregnant or breast-feeding, ask a health professional before use.
- Other information
- Inactive ingredients
- PACKAGE LABEL
INGREDIENTS AND APPEARANCE
standardized senna concentrate tablet
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53808-1110(NDC:57896-451) 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 CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J) MAGNESIUM SILICATE (UNII: 9B9691B2N9) MAGNESIUM STEARATE (UNII: 70097M6I30) MINERAL OIL (UNII: T5L8T28FGP) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) Product Characteristics Color BROWN (light brown) Score no score Shape ROUND Size 9mm Flavor Imprint Code 1122 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53808-1110-1 30 in 1 BLISTER PACK; Type 0: Not a Combination Product 01/09/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part334 01/09/2018 Labeler - DOH CENTRAL PHARMACY (829348114) Establishment Name Address ID/FEI Business Operations DOH CENTRAL PHARMACY 829348114 repack(53808-1110)