Active Ingredients (In Each Tablet)
Docusate Sodium 50 mg
Sennosides 8.6 mg
Colistat Plus
FDA Label NDC 69975-850
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Amvilab Llc for the product Colistat Plus (NDC 69975-850). 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 ingredients (in each tablet), purposes, uses, do not use, ask a doctor before use if you have, 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
Purposes
Docusate Sodium.............................Stool Softener
Sennosides.......................................Laxative
Uses
- relieves occasional constipation (irregularity)
- generally produces a bowel movement in 6-12 hours
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
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 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 dose | maximum dose |
| adults and children 12 years and 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 20 mg
- Each tablet contains: Sodium 4 mg
- Store at room temperature
- Keep lid tightly closed in a dry place
- Do not use if imprinted seal under cap is broken or missing
- Tamper Evident: Do not use if sealed blister unit is broken or damaged
Inactive Ingredients
Croscarmellose Sodium, D and C Yellow #10, Dextrose, Dicalcium Phosphate, FD and C Yellow #6, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Silica, Sodium Benzoate, Stearic Acid, Titanium Dioxide.
Questions?
If you have any questions or comments,or to report an adverse event, please contact +1 404 256 8817.
Principal Display Panel
COLISTAT PLUS
Stool Softener and Stimulant Laxative
- Effective
- Reliable
- Comfortable
60 TABLETS
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