GERI-KOT- standardized senna concentrate tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX)

Available from:

Geri-Care Pharmaceutical Corp

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Laxative - relieves occasional constipation (irregularity) - generally produces bowel movement in 6 to 12 hours

Authorization status:

OTC monograph not final

Summary of Product characteristics

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._
----------
GC 450
ACTIVE INGREDIENT (IN EACH TABLET)
Sennosides 8.6 mg
PURPOS E
Laxative
US ES
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
GERI-KOT
standardized senna concentrate tablet
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:578 9 6 -450
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
SE