DOCUSATE SODIUM- docusate sodium tablet, film coated 
DIRECTRX

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DOCUSATE SODIUM AND SENNA

Sennosides from Senna Concentrate 8.6mg

Docusate Sodium 50mg

Laxative

Stool Softner


elieves occasional constipation (irregularity)
generally produces a bowel movement in 6-12 hours

Do not use

laxative products for longer than 1 week unless directed by a doctor
if you are taking mineral oil, 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 the use of a laxative. These may indicate a serious condition.

If pregnant or breast feeding,

ask a healthcare professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center immediately.

take preferably at bedtime or as directed by a doctor

age

starting dosage

maximum dosage

Adults and children 12 years and over

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

each tablet contains 10 mg of calcium, sodium 5 mg
store at 25°(77°F); excursions permitted between 15o-30oC (59o-86oF)


crosscarmellose Sodium, D&C Yellow# 10, dicalcium phosphate, FD&C Yellow #6, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, polyethylene glycol, sodium benzoate, talc, titanium dioxide


866) 562-2756 Mon-Fri 8 AM to 4 PM EST

Directions:

Take preferably at bedtime or as directed by a doctor. If you do not have a comfortable bowel movement by the second day, increase dose by one tablet (not to exceed maximum dosage) or decrease dose until you are comfortable.

Adults and children 12 years and over - starting dosage: 2 tablets once a day maximum dosage: 4 tablets twice a day

Children 6 to under 12 years - starting dosage: 1 tablet once a day maximum dosage: 2 tablets twice a day

Children to2 to under 6 years - starting dosage: 1/2 tablet once a day maximum dosage: 1 tablet twice a day

Children under 2 years - Ask a doctor

Uses:

Relieves occasional constipation (irregularity); generally causes bowel movement in 6-12 hours


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

498-60

DOCUSATE SODIUM 
docusate sodium tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61919-498(NDC:16103-378)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX) SENNOSIDES8.6 mg
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM50 mg
Inactive Ingredients
Ingredient NameStrength
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
Product Characteristics
Colororange (ORANGE COLOR) Scoreno score
ShapeROUND (ROUND TABLET) Size10mm
FlavorImprint Code PH32
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61919-498-6060 in 1 BOTTLE; Type 0: Not a Combination Product11/05/201810/06/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00711/05/201810/06/2023
Labeler - DIRECTRX (079254320)
Registrant - DIRECTRX (079254320)
Establishment
NameAddressID/FEIBusiness Operations
DIRECTRX079254320repack(61919-498)

Revised: 10/2023
 
DIRECTRX