GERI-KOT  - standardized senna concentrate tablet 
DOH CENTRAL PHARMACY

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.

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Active ingredient (in each tablet)

Sennosides 8.6 mg

Purpose

Laxative

Uses

Warnings

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.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

• do not exceed 8 tablets in 24 hours

Age
Starting Dose
Maximum Dose
adults and children 12 years of age and older
2 tablets once a day preferably at bedtime; increase as needed, or as directed by a doctor
4 tablets in the morning and 4 tablets at bedtime
children under 12 years
ask a doctor



Other information

• each tablet contains: calcium 20 mg
• store at room temperature

This Product was Repackaged By:

DOH CENTRAL PHARMACY
104 HAMILTON PARK DR # 2
TALLAHASSEE, FL 32304
USA

Inactive ingredients

cellulose, croscarmellose sodium, dicalcium phosphate, hypromellose, magnesium silicate, magnesium stearate, mineral oil, PEG.

PACKAGE LABEL

Label Image for 53808-1110
8.6mg

Label Image for 8.6mg
GERI-KOT  
standardized senna concentrate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53808-1110(NDC:57896-451)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX) SENNOSIDES8.6 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorBROWN (light brown) Scoreno score
ShapeROUNDSize9mm
FlavorImprint Code 1122
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53808-1110-130 in 1 BLISTER PACK; Type 0: Not a Combination Product01/09/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart33401/09/2018
Labeler - DOH CENTRAL PHARMACY (829348114)
Establishment
NameAddressID/FEIBusiness Operations
DOH CENTRAL PHARMACY829348114repack(53808-1110)

Revised: 1/2019
Document Id: 0fd2010f-72b2-4243-af6d-d1a4d5315646
Set id: d5683aba-5292-4a36-9ba7-52d322779111
Version: 1
Effective Time: 20190117
 
DOH CENTRAL PHARMACY