Active Ingredient (In Each Tablet)
Docusate Sodium 50 mg
Sennosides 8.6 mg
Sennosides And Docusate Sodium Tablet
FDA Label NDC 60687-622
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by American Health Packaging for the product Sennosides And Docusate Sodium (NDC 60687-622). 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, ask a doctor before use if you, stop use and ask a doctor if, if pregnant or breast-feeding,, 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
Purpose
Stool softener
Laxative
Uses
- relieves occasional constipation (irregularity)
- this product generally produces a bowel movement in 6 to 12 hours
Warnings
Do not use for more than one week unless directed by a doctor.
Ask A Doctor Before Use If You
- have abdominal pain, nausea or vomiting
- are taking mineral oil
- have noticed a sudden change in bowel habits that lasts over two weeks
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
- do not exceed 8 tablets in 24 hours
- Adults and children 12 years of age and older take 2 tablets once a day preferably at bedtime; increase as needed, or as directed by a doctor; the maximum dose should be 4 tablets in the morning and 4 tablets at bedtime
- Children under 12 years ask a doctor
Other Information
- each tablet contains: calcium 20 mg, sodium 3 mg
- store at controlled room temperature
- Keep this and all drugs out of reach of children.
- FOR YOUR PROTECTION: Do not use if blister is torn or broken.
Inactive Ingredients
cellulose, croscarmellose sodium, dicalcium phosphate, FD&C yellow #6 lake, hypromellose, magnesium stearate, PEG, silica, talc, titanium dioxide.
Packaging Information
The drug product contained in this package is from NDC # 57896-555, Geri-Care Pharmaceuticals Corp.
Distributed by:
American Health Packaging, Columbus, Ohio 43217
762201
0462201/0621
Package/Label Display Panel – Carton – 8.6 Mg/50 Mg
8.6 mg/50 mg Sennosides And Docusate Sodium Tablets Carton (Carton)
NDC 60687- 622-01
Sennosides* and Docusate Sodium Tablets
Natural Vegetable Laxative with Stool Softener
*Standardized Senna Concentrate
8.6 mg/50 mg
100 Tablets (10 x 10)
Drug Facts
Active ingredients (in each tablet)......................................................................Purpose
Docusate Sodium 50 mg...............................................................................Stool softener
Sennosides 8.6 mg............................................................................................... Laxative
The drug product contained in this package is from
NDC # 57896-555, Geri-Care Pharmaceuticals Corp.
Distributed by:
American Health Packaging, Columbus, Ohio 43217
762201
0462201/0621
Package/Label Display Panel – Blister – 8.6 Mg/50 Mg
8.6 mg/50 mg Sennosides And Docusate Sodium Tablet Blister (Blister)
Sennosides and Docusate
Sodium Tablet
Laxative/Stool Softener
8.6 mg/50 mg
* Please review the disclaimer below.
