Active Ingredient (In Each Tablet)
Sennosides USP, 8.6 mg
Vegetable Laxative Tablet, Film Coated
FDA Label NDC 63868-579
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Chain Drug Marketing Association Inc for the product Vegetable Laxative (NDC 63868-579). 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, do not use, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Stimulant laxative
Uses
- relieves occasional constipation (irregularity)
- generally produces a bowel movement in 6 to 12 hours
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 continues over a period of 2 weeks
When Using This Product
do not exceed recommended dosage.
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.
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
| age | starting dosage | maximum dosage |
| adults and children 12 years and over | 2 tablets once a day | 4 tablets twice a day |
| children 6 to under 12 years | 1 tablet once a day | 2 tablets twice a day |
| children 2 to under 6 years | 1/2 tablet once a day | 1 tablet twice a day |
| children under 2 years | ask a doctor | ask a doctor |
Other Information
- each tablet contains: calcium 30 mg, sodium 1 mg Very Low Sodium
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- protect from moisture
- see end flap for expiration date and lot number
Inactive Ingredients
croscarmellose sodium, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, silicon dioxide
Questions Or Comments?
1-800-426-9391
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CHOICE
NDC 63868-579-01
Compare to the
Active Ingredient in
Senokot®*
Vegetable Laxative
Sennosides USP, 8.6 mg
Stimulant Laxative
Vegetable Laxative Ingredient
for Gentle Constipation Relief
100 Tablets
Actual Size
TAMPER EVIDENT: DO NOT USE IF IMPRINTED
SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
*This product is not manufactured or distributed by
Avrio Health L.P., owner of the registered trademark
Senokot®.
50844 REV1020C29812
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