Active Ingredient (In Each Tablet)
Docusate Sodium 50 mg
Sennosides 8.6 mg
Senna-plus Tablet
FDA Label NDC 71335-1674
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Bryant Ranch Prepack for the product Senna-plus (NDC 71335-1674). 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, warnings, otc - keep out of reach of children, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Stool softener
Laxative
Uses
- relieves occasional constipation (irregularity)
- this product generally produces a bowel movement in 6 to 12 hours
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
- have noticed a sudden change in bowel habits that lasts over two weeks
Stop use and ask a doctor if you 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.
Otc - Keep Out Of Reach Of Children
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 20 mg, sodium 3 mg
- store at controlled room temperature
Tamper Evident: Do not use if imprinted seal under cap is missing or broken. - product of India
Inactive Ingredients
cellulose, croscarmellose sodium, dicalcium phosphate, FD&C yellow #6 lake, hypromellose, magnesium stearate, PEG, silica, talc, titanium dioxide.
How Supplied
Product: 71335-1674
NDC: 71335-1674-1 30 TABLET in a BOTTLE
NDC: 71335-1674-2 120 TABLET in a BOTTLE
NDC: 71335-1674-3 60 TABLET in a BOTTLE
NDC: 71335-1674-4 90 TABLET in a BOTTLE
NDC: 71335-1674-5 100 TABLET in a BOTTLE
NDC: 71335-1674-6 28 TABLET in a BOTTLE
NDC: 71335-1674-7 56 TABLET in a BOTTLE
NDC: 71335-1674-8 14 TABLET in a BOTTLE
NDC: 71335-1674-9 20 TABLET in a BOTTLE
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