Other
Drug Facts
Drug Facts (continued)
Senna
FDA Label NDC 70000-0441
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cardinal Health for the product Senna (NDC 70000-0441). 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 other, active ingredient (in each softgel), purpose, uses, warnings, do not use, ask a doctor before use if you have, 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
Warnings
Do Not Use
■ laxative products for longer than 1 week, unless directed by a 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 (1-800-222-1222) right away.
Directions
■ take preferably at bedtime or as directed by a doctor
| Age | Starting Dosage | Maximum Dosage |
| adults and children 12 years of age or over | 2 softgels once a day | 4 softgels twice a day |
| children 6 to under 12 years | 1 softgel 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
Otc - Questions
Questions or comments? 1-888-333-9792
Principal Display Panel - Leader™ Regular Strngth Senna 60 Softgels Bottle Carton
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NDC 70000-0441-1
Regular Strength
Senna
Sennosides, 8.6 mg | Laxative
Standardized
Senna Concentrate
Natural Vegetable Laxative Ingredient
60 SOFTGELS
Actual Size
*This product is not manufactured or distributed by Purdue Products L.P., owner of the registered trademark Senokot® Regular Strength.
* Please review the disclaimer below.
