GERI-KOT- standardized senna concentrate tablet
Geri-Care Pharmaceutical Corp

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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gc 450

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 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 25 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.

Package Label

GERICARE
NDC 57896-450-01
Geri-kot
Standardized Senna Concentrate
COMPARE TO ACTIVE INGREDIENT
IN SENOKOT TABLETS
Natural Vegetable Laxative
100 Tablets
8.6 mg Each

420

GERI-KOT
standardized senna concentrate tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:57896-450
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX)	SENNOSIDES	8.6 mg

Ingredient Name	Strength
Inactive Ingredients
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	9mm
Flavor		Imprint Code	TCL080
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:57896-450-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	12/28/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	01/01/2000	02/01/2020

Labeler - Geri-Care Pharmaceutical Corp (611196254)

Registrant - Geri-Care Pharmaceutical Corp (611196254)

Name	Address	ID/FEI	Business Operations
Establishment
Geri-Care Pharmaceutical Corp		611196254	repack(57896-450)

Revised: 12/2020

Document Id: b6721434-cc3f-cf76-e053-2a95a90a6c1f

Set id: 616bfb9f-e492-f10e-e053-2a91aa0a54ad

Version: 3

Effective Time: 20201214

Geri-Care Pharmaceutical Corp