GERI-KOT- standardized senna concentrate tablet

Geri-kot by

Drug Labeling and Warnings

Geri-kot by is a Otc medication manufactured, distributed, or labeled by Geri-Care Pharmaceutical Corp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each tablet)

Sennosides 8.6 mg

Purpose

Laxative

Uses

• relieves occasional constipation (irregularity)

• generally produces bowel movement in 6 to 12 hours

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 rectal bleeding or fail to
have a bowel movement after use of a laxative.
These may indicate 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 40 mg
• Tamper Evident: Do not use if imprinted seal under cap is missing or broken
• store at room temperature

Inactive ingredients

cellulose, croscarmellose sodium,
dicalcium phosphate, hypromellose*, magnesium silicate*,
magnesium stearate, mineral oil*, PEG*, silica*, wax*.
*May contain these ingredients

Package Label

INGREDIENTS AND APPEARANCE

GERI-KOT 
standardized senna concentrate tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57896-454
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
CARNAUBA WAX (UNII: R12CBM0EIZ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)
MAGNESIUM SILICATE (UNII: 9B9691B2N9)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MINERAL OIL (UNII: T5L8T28FGP)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
HYPROMELLOSES (UNII: 3NXW29V3WO)

Product Characteristics
Color	brown	Score	no score
Shape	ROUND	Size	8mm
Flavor		Imprint Code	AZ217
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57896-454-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	08/01/2018
2	NDC: 57896-454-10	1000 in 1 BOTTLE; Type 0: Not a Combination Product	04/01/2018
3	NDC: 57896-454-20	200 in 1 BOTTLE; Type 0: Not a Combination Product	08/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	04/01/2018

Labeler - Geri-Care Pharmaceutical Corp (611196254)

Registrant - Geri-Care Pharmaceutical Corp (611196254)

Establishment
Name	Address	ID/FEI	Business Operations
Geri-Care Pharmaceutical Corp		611196254	repack(57896-454)