Active Ingredient
Sennosides from Senna Concentrate 8.6mg
Docusate Sodium 50mg
Senna Plus
FDA Label NDC 21695-722
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Rebel Distributors Corp for the product Senna Plus (NDC 21695-722). 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, purpose, uses, warnings, directions, other information, inactive ingredients, package/label principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Laxative & Stool Softener
Uses
For the short term relief of constipation. Produces bowel movement in 6 to 12 hours.
Warnings
Do not use ° for longer than one week ° when abdominal pain, nausea or vomiting are present.
Ask a doctor or pharmacist before use if you have noticed a sudden change in bowel habits that lasts over a period of two weeks.
Stop use and ask a doctor if ° you have rectal bleeding ° you fail to have a bowel movement after use of this product, this may indicate a serious condition.
If pregnant or breast-feeding, ask a health care 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
° Take preferably at bedtime or as directed by a doctor ° if you do not have a comfortable bowel movement by the second day, increase dose by one table (do not exceed the maximum dosage) or decrease dose until you are comfortable.
Adults & children over 12 years: 2 tablets once a day (maximum dosage, 4 tablets twice a day)
Children 6 to under 12 years: 1 tablet once a day (maximum dosage, 2 tablets twice a day)
Children 2 to under 6 years: 1.2 tablet once a day (maximum dosage, 1 tablet twice a day)
Children under 2 years: do not use
Other Information
Store at room temperature, USP.
Inactive Ingredients
Croscarmellose Sodium, Dicalcium Phosphate, FD&C Yellow No. 5, FD&C Yellow No. 6, Hypromellose, Magnesium Silicate, Magnesium Stearate, Microcrystalline Cellulose, Mineral Oil, Polyethylene Glycol, Sodium Benzoate, Starch, Stearic Acid and Titanium Dioxide.
Distributed by: Plus Pharma
Commack, NY 11725
Repackaged by: Rebel Distributors Corp
Thousand Oaks, CA 91320
Package/Label Principal Display Panel
Senna 8.6mg (5b17afd8 De62 4684 B556 D2846eb214b8 01)
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