Otc - Active Ingredient
Active ingredients (in each tablet)
Docusate Sodium 50mg
Sennosides 8.6m
Foster And Thrive Senna-s Sennosides And Docusate Sodium Laxative And Stool Softener Tablet
FDA Label NDC 70677-1309
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Strategic Sourcing Services Llc for the product Foster And Thrive Senna-s Sennosides And Docusate Sodium Laxative And Stool Softener (NDC 70677-1309). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - ask doctor, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Stool softener
Laxative
Indications & Usage
Uses
■
relieves occasional constipation (irregularity)
■ generally produces a bowel movement in 6 – 12 hours
Warnings
Warnings
Do not use
■ if you are now taking mineral oil, unless directed by a doctor
■ 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 continues over a period of 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).
Dosage & Administration
Directions
■ take preferably at bedtime or as directed by a doctor
| Age | Starting Dosage | Maximum Dosage |
| Adults and children 12 years of age and older | 2 tablets once a day | 4 tablets twice a day |
| children 6 to under 12 years | 1 tablets 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 Safety Information
Other information
■
each tablet contains: calcium 20mg and sodium 5mg
■ store at 20–25°C (68–77°F)
Inactive Ingredient
Inactive ingredients
colloidal silicon dioxide, croscarmellose sodium, dicalcium
phosphate, FD&C Red 40 Lake, hypromellose, magnesium stearate, microcrystalline cellulose,
polyethylene glycol, stearic acid, titanium dioxide
Otc - Questions
Questions or comments?
Call 833-358-6431 Mon to Fri 9:00am to 7:00pm EST
Package Label.Principal Display Panel
Primary Display Panel
Pdp (Senna S Label)
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