Senna
FDA Label NDC 11822-1571
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Rite Aid Corporation for the product Senna (NDC 11822-1571). 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 drug facts, active ingredient (in each softgel), purpose, uses, warnings, otc - do not use, otc - ask doctor, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient (In Each Softgel)
Sennosides 8.6 mg
Purpose
Laxative
Uses
• relieves occasional constipation (irregularity) • generally produces bowel movement in 6–12 hours
Warnings
Otc - Do Not Use
Do not use laxative products for longer than 1 week, unless directed by a doctor
Otc - Ask Doctor
Ask a doctor before use if you have • stomach pain • nausea • vomiting • noticed a sudden change in bowel habits that lasts over 2 weeks
Otc - Stop Use
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
Otc - Pregnancy Or Breast Feeding
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 (1-800-222-1222).
Directions
take preferably at bedtime or as directed by a doctor
| Age | Starting Dosage | Maximum Dosage |
| adults & children 12 years of age & over | 2 softgels once a day | 4 softgels twice a day |
| children 6 to under 12 years of age | 1 softgels once a day | 2 softgels twice a day |
| children under 6 years of age | ask a doctor | ask a doctor |
Other Information
• each softgel contains: calcium 1 mg and sodium less than 1 mg
• store at 25°C (77°F); excursions permitted between 15°–30°C (59°–86°F)
Inactive Ingredients
aerosil, beeswax, FD&C Blue No. 1, FD&C Red No.40, FD&C Yellow
No. 6, gelatin, glycerin, light liquid paraffin, povidone (PVP K-30), purified water, sodium carboxymethyl cellulose, sorbitol solution, soya lecithin, titanium dioxide
Questions Or Comments?
1-888-333-9792
Other
Distributed by:
RITE AID
30 Hunter Lane, Camp Hill, PA 17011
www.riteaid.com
Made in India
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