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Sennosides And Docusate Sodium Tablet
FDA Label NDC 69618-065
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Reliable-1 Laboratories Llc for the product Sennosides And Docusate Sodium (NDC 69618-065). 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 tablet), purpose, uses, warnings, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient (In Each Tablet)
Docusate sodium 50 mg
Sennosides 8.6 mg
Purpose
Stool softener
Stimulant laxative
Uses
relieves occasional constipation (irregularity)
generally produces a bowel movement in 6 to 12 hours
Warnings
Do not use
this product if you are presently taking mineral oil, unless directed by a doctor
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
Stop use and ask a doctor if you have rectal bleeding or fail to have 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
do not exceed maximum dosage
| age | starting dosage | maximun dosage |
| adults and children 12 years of age or older | 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 4 mg, sodium 8 mg
store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
Inactive Ingredients
colloidal silicon dioxide, croscarmellose sodium, D&C Yello #10 Aluminum Lake, FD&C Yellow #6 Aluminum Lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, stearic acid, titanium dioxide
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Package Label.Principal Display Panel
NDC 69618-065-01
Senna Plus
Sennosides 8.6 mg
Docusate sodium 50 mg
NATURAL VEGETABLE
LAXATIVE AND
STOOL SOFTENER
100 TABLETS
*Compare to active ingredients in SENOKOT-S®
* Please review the disclaimer below.
