Active Ingredient (In Each Tablet)
Sennosides 8.6mg
Senna Laxative Tablet, Film Coated
FDA Label NDC 43063-838
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Pd-rx Pharmaceuticals, Inc. for the product Senna Laxative (NDC 43063-838). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient (in each tablet), purpose, uses, do not use, ask a doctor before use if you, stop use and ask a doctor if, if pregnant or breast-feeding,, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Laxative
Uses
- relieves occasional constipation (irregularity)
- this product generally produces a bowel movement in 6 to 12 hours
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.
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
|
Other Information
- Tamper Evident: Do not use if safety seal under cap is broken or missing
- each tablet contains: calcium 20 mg, potassium 70 mg
- store at room temperature
Inactive Ingredients:
croscarmellose sodium, dicalcium phosphate, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil
Questions?
Adverse drug event call: (866) 562-2756
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)
Package Label.Principal Display Panel
Image (43063838)
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