Registrants (1)
611196254
Products (1)
Geri-kot
57896-454
505G(a)(3)
OTC Monograph Drug (C200263)
ORAL
May 15, 2025
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Package Label
INDICATIONS & USAGE SECTION
Uses
-
relieves occasional constipation (irregularity)
-
generally produces bowel movement in 6 to 12 hours
DOSAGE & ADMINISTRATION SECTION
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 |
WARNINGS SECTION
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 ifyou 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.
STORAGE AND HANDLING SECTION
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
OTC - ACTIVE INGREDIENT SECTION
Active ingredient (in each tablet)
Sennosides 8.6 mg
OTC - PURPOSE SECTION
Purpose
Laxative
INACTIVE INGREDIENT SECTION
Inactive ingredients
cellulose, croscarmellose sodium,
dicalcium phosphate, hypromellose*, magnesium silicate*,
magnesium stearate, mineral oil*, PEG*, silica*, wax*.
*May contain these ingredients