FDA Label for Sennosides And Docusate Sodium
View Indications, Usage & Precautions
Sennosides And Docusate Sodium Product Label
The following document was submitted to the FDA by the labeler of this product Reliable-1 Laboratories Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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Drugs Facts
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.