PLUSPHARMA STOOL SOFTENER- docusate sodium tablet, film coated 
Gemini Pharmaceuticals, Inc. dba Plus Pharma

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.

----------

Plus Pharma Docusate Sodium 100 mg Tablets

Drug Facts

Active ingredient (in each tablet)

Docusate Sodium 100 mg

Purpose

Stool softener

Uses

  • for relief of occasional constipation (irregularity)
  • this product generally produces a bowel movement within 12 to 72 hours

Warnings

Do not use if you are presently taking mineral oil unless told to do so by a doctor.

Ask a doctor before use if you have

  • stomach pain
  • nausea
  • vomiting
  • noticed a sudden change in bowel habits that lasts over 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 could be signs of a serious condition.
  • you need to use a stool softener laxative for longer than one week

If pregnant or breast-feeding, ask a doctor before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

  • adults and children 12 years and older:
  • take 1 tablet as needed, not to exceed 3 tablets daily, or as directed by a doctor
  • tablets may be swallowed whole or crushed and mixed with food
  • children under 12 years: consult a doctor before use

Other information

  • each tablet contains: c alcium 40 mg, s odium 10 mg
  • store at room temperature in a dry place

Inactive ingredients

croscarmellose sodium, dicalcium phosphate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, silica, sodium benzoate, stearic acid

Questions? If you have any questions or comments, or to report an adverse event, please contact (800)-795-9775.

DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Distributed By:

Plus Pharma

Commack, NY 11725

Manufactured in a GMP facility in the USA

PlusPHARMA

NDC 51645-750-01

DOCUSATE SODIUM 100 mg

Stool Softener

Relieves Occasional Constipation (Irregularity)

Crushable Tablets for Ease of Administration

Contains no ingredient made from a gluten-containing grain (wheat, barley, or rye).

*Compare to the Active Ingredient in Colace®

*Plus Pharma is not affiliated with the owner of the registered trademark Colace®

100 TABLETS • 100 mg each

SS 100 mg 100-ct

PLUSPHARMA  STOOL SOFTENER
docusate sodium tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51645-750
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM100 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
STARCH, CORN (UNII: O8232NY3SJ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorwhiteScore2 pieces
ShapeROUND (Round Biconvex with bisect) Size11mm
FlavorImprint Code GPI;S1
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51645-750-9910 in 1 CARTON03/27/200611/30/2018
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:51645-750-01100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/27/200609/30/2020
3NDC:51645-750-101000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/27/200611/30/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33403/27/200611/30/2021
Labeler - Gemini Pharmaceuticals, Inc. dba Plus Pharma (055942270)
Establishment
NameAddressID/FEIBusiness Operations
Gemini Pharmaceuticals, Inc. dba Plus Pharma055942270manufacture(51645-750)

Revised: 11/2020
 
Gemini Pharmaceuticals, Inc. dba Plus Pharma