Geri-kot
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7aa66bf1-d765-adce-e053-2991aa0a93a3
HUMAN OTC DRUG LABEL
May 15, 2025
Geri-Care Pharmaceutical Corp
DUNS: 611196254
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Standardized Senna Concentrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (11)
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
OTC - ACTIVE INGREDIENT SECTION
Active ingredient (in each tablet)
Sennosides 8.6 mg
OTC - PURPOSE SECTION
Purpose
Laxative
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.
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 |
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
INACTIVE INGREDIENT SECTION
Inactive ingredients
cellulose, croscarmellose sodium,
dicalcium phosphate, hypromellose*, magnesium silicate*,
magnesium stearate, mineral oil*, PEG*, silica*, wax*.
*May contain these ingredients