Senna Laxative
Drug Facts
2b03d07c-ea4f-4663-bcc3-20ebdf83b7aa
HUMAN OTC DRUG LABEL
May 21, 2025
PD-Rx Pharmaceuticals, Inc.
DUNS: 156893695
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Senna
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (7)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
INDICATIONS & USAGE SECTION
Uses
-
relieves occasional constipation (irregularity)
-
this product generally produces a bowel movement in 6 to 12 hours
OTC - ACTIVE INGREDIENT SECTION
Active ingredient (in each tablet)
Sennosides 8.6mg
OTC - PURPOSE SECTION
Purpose
Laxative
WARNINGS SECTION
Warnings
Do not use
for more than one week unless directed by a doctor
Ask a doctor before use if you
- have abdominal pain, nausea, or vomiting
- are taking mineral oil
- noticed a sudden change in bowel habits that last 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.
DOSAGE & ADMINISTRATION SECTION
Directions
- do not exceed recommended dose
|
Age |
Starting Dose |
Maximum Dose |
|
adults and children 12 years of age and older |
2 tablets once a day preferably at bedtime; increase if needed, or as directed by a doctor |
4 tablets twice a day, in the morning and at bedtime |
|
children under 12 years |
ask a doctor |
ask a doctor |
STORAGE AND HANDLING SECTION
Other information
***Tamper Evident:**Do not use if safety seal is broken or missing from bottle.
-
each tablet contains: calcium 20 mg, potassium 70 mg
-
store at room temperature
INACTIVE INGREDIENT SECTION
Inactive ingredients:
croscarmellose sodium, dicalcium phosphate, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil
OTC - QUESTIONS SECTION
Questions?
Adverse drug event call: (866) 562-2756
HOW SUPPLIED SECTION
16 HOW SUPPLIED
Senna Laxative Tablets are available as follows:
8.6 mg: Brown, round, scored tablet, debossed “SB”. Available in bottles of
10 tablets (NDC 43063-838-10)
30 tablets (NDC 43063-838-30)