DOCUSATE SODIUM 50 MG & SENNOSIDES 8.6 MG CAPSULES (ORANGE)

Docusate Sodium and Sennosides by

Drug Labeling and Warnings

Docusate Sodium and Sennosides by is a Otc medication manufactured, distributed, or labeled by SOFTGEL HEALTHCARE PRIVATE LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DOCUSATE SODIUM AND SENNOSIDES- docusate sodium and sennosides capsule, liquid filled 
SOFTGEL HEALTHCARE PRIVATE LIMITED

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DOCUSATE SODIUM 50 MG & SENNOSIDES 8.6 MG CAPSULES (ORANGE)

Active ingredient (in each softgel)

Docusate Sodium 50 mg

Sennosides 8.6 mg

Purpose

  • Stool softener
  • Laxative

Uses

  • relieves occasional constipation (irregularity)
  • generally causes bowel movement in 6-12 hours

Warning
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 movements 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 be signs of a serious condition.

If pregnant or breast-feeding

ask a health professional before use.

Keep out of reach of children

In case of accidental overdose, seek professional assistance or contact a Poison Control Center right away.

Directions

  • take preferably at bedtime or as directed by a doctor.
AgeStarting DosageMaximum Dosage
adults and children 12 years of age or older2 softgels once a day4 softgels twice a day
children 6 to 12 years of age1 softgel once a day

2 softgels twice a day
children under 6 years of ageask a doctorask a doctor

Other Information

  • each softgel contains: Sodium 3 mg
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°- 86°F)

Inactive Ingredient

Propylene glycol, Povidone, Colloidal Silicon Dioxide, Yellow wax, Polyethylene glycol 400, Gelatin, Glycerin, Sorbitol Sorbitan Solution, FD&C Yellow No.6, Titanium dioxide and Purified water.

Bottle Label

DOCUSATE SODIUM AND SENNOSIDES 
docusate sodium and sennosides capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 35916-0448
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM50 mg
SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX) SENNOSIDES8.6 mg
Inactive Ingredients
Ingredient NameStrength
1,4-SORBITAN (UNII: AV0YTZ4E6J)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
SORBITOL (UNII: 506T60A25R)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
WATER (UNII: 059QF0KO0R)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
POVIDONE K30 (UNII: U725QWY32X)  
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
Product Characteristics
Colororange (Opaque) Scorescore with uneven pieces
ShapeCAPSULE (oval) Size5mm
FlavorImprint Code 902
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 35916-0448-2500 in 1 BOTTLE; Type 0: Not a Combination Product05/15/202405/16/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00705/15/202405/16/2024
Labeler - SOFTGEL HEALTHCARE PRIVATE LIMITED (675584180)
Establishment
NameAddressID/FEIBusiness Operations
SOFTGEL HEALTHCARE PRIVATE LIMITED675584180manufacture(35916-0448)

Revised: 5/2024
Document Id: 165cf0fd-b7ba-2bae-e063-6294a90a99a9
Set id: 15671380-5fd8-b2ab-e063-6294a90a9031
Version: 2
Effective Time: 20240515