Label: COLISTAT PLUS- docusate sodium,sennosides tablet, film coated
-
Contains inactivated NDC Code(s)
NDC Code(s): 69975-850-06 - Packager: Amvilab LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated July 16, 2015
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients (in each tablet)
- Purposes
- Uses
-
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
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
- if you are now taking mineral oil, unless directed by a doctor
-
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
- Inactive ingredients
- Questions?
- Principal Display Panel
-
INGREDIENTS AND APPEARANCE
COLISTAT PLUS
docusate sodium,sennosides tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69975-850 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM 50 mg SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX) SENNOSIDES 8.6 mg Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) DEXTROSE (UNII: IY9XDZ35W2) CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) HYPROMELLOSES (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM BENZOATE (UNII: OJ245FE5EU) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color orange Score no score Shape ROUND (Biconvex) Size 10mm Flavor Imprint Code G55 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69975-850-06 60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 07/16/2015 Labeler - Amvilab LLC (006092439) Registrant - Gemini Pharmaceuticals, Inc. dba Plus Pharma (055942270) Establishment Name Address ID/FEI Business Operations Gemini Pharmaceuticals, Inc. dba Plus Pharma 055942270 manufacture(69975-850)