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DOCUSATE SODIUM AND SENNA by DIRECT RX

Medically reviewed on November 9, 2017

Dosage form: tablet, film coated
Ingredients: DOCUSATE SODIUM 50mg, SENNOSIDES 8.6mg
Labeler: DIRECT RX
NDC Code: 61919-518

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.

DOCUSATE SODIUM AND SENNA

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each tablet)
Docusate Sodium 50 mg
Sennosides 8.6 mg

OTC - PURPOSE SECTION

Purposes
Stool Softener
Stimulant Laxative

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

 KEEP OUT OF REACH OF CHILDREN SECTION

INDICATIONS & USAGE SECTION

Uses

  • relieves occasional constipation
  • generally produces bowel movement in 6-12 hours

WARNINGS SECTION

Warnings

OTC - DO NOT USE SECTION

Do not use

  • for longer than one week
  • if you are taking mineral oil
  • when abdominal pain, nausea or vomiting are present

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have noticed a sudden change in bowel habits that lasts over two weeks

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • you have rectal bleeding
  • you fail to have a bowel movement after use of this product.

These may indicate a serious condition.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.
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DOSAGE & ADMINISTRATION SECTION

Directions
adults and children 12 years and over: 2-4 tablets once daily or in divided doses
children 6 to under 12 years: 1-2 tablets once daily or in divided doses
children 2 to under 6 years: 1/2-1 tablet once daily or in divided doses
children under 2 years: ask a doctor

STORAGE AND HANDLING SECTION

Other information
each tablet contains: calcium 20 mg, sodium 6 mg (LOW SODIUM)
store at 20°-25°C (68°-77°F)

INACTIVE INGREDIENT SECTION

Inactive ingredients carnauba wax, colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, FD-C blue #2 aluminum lake, FD-C red #40 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol (PEG), sodium benzoate, stearic acid, titanium dioxide

OTC - QUESTIONS SECTION

Questions or comments?
call 1-800-645-2158, 9 am - 5 pm ET, Monday - Friday

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DOCUSATE SODIUM AND SENNA 
docusate sodium and senna tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61919-518(NDC:0536-0355)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM50 mg
SENNOSIDES (SENNOSIDES) SENNOSIDES8.6 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX 
CROSCARMELLOSE SODIUM 
DIBASIC CALCIUM PHOSPHATE DIHYDRATE 
FD&C BLUE NO. 2 
FD&C RED NO. 40 
HYPROMELLOSE 2910 (6 MPA.S) 
HYPROMELLOSE 2910 (15 MPA.S) 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOL 400 
SODIUM BENZOATE 
STEARIC ACID 
TITANIUM DIOXIDE 
Product Characteristics
ColorpurpleScoreno score
ShapeROUNDSize10mm
FlavorImprint CodeTCL;131
Contains    
Packaging
#Item CodePackage Description
1NDC:61919-518-6060 BOTTLE in 1 BOTTLE
1NDC:61919-518-3030 BOTTLE in 1 BOTTLE
1NDC:61919-518-71100 TABLET, FILM COATED in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33401/01/2014
Labeler - DIRECT RX (079254320)
Establishment
NameAddressID/FEIOperations
DIRECT RX079254320relabel(61919-518), repack(61919-518)

 
DIRECT RX

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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