DOCUSATE SODIUM tablet, film coated

DOCUSATE SODIUM by

Drug Labeling and Warnings

DOCUSATE SODIUM by is a Otc medication manufactured, distributed, or labeled by DIRECTRX. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Sennosides from Senna Concentrate 8.6mg

Docusate Sodium 50mg

PURPOSE

Laxative

Stool Softner

PURPOSE

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

WARNINGS

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.

INSTRUCTIONS FOR USE

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

STORAGE AND HANDLING

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

INACTIVE INGREDIENT

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

QUESTIONS

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

DOSAGE & ADMINISTRATION

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

INDICATIONS & USAGE

Uses:

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

KEEP OUT OF REACH OF CHILDREN

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DOCUSATE SODIUM 
docusate sodium tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61919-498(NDC:16103-378)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX)	SENNOSIDES	8.6 mg
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)	DOCUSATE SODIUM	50 mg

Inactive Ingredients
Ingredient Name	Strength
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
MAGNESIUM STEARATE (UNII: 70097M6I30)
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)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)

Product Characteristics
Color	orange (ORANGE COLOR)	Score	no score
Shape	ROUND (ROUND TABLET)	Size	10mm
Flavor		Imprint Code	PH32
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61919-498-60	60 in 1 BOTTLE; Type 0: Not a Combination Product	11/05/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	11/05/2018

Labeler - DIRECTRX (079254320)

Registrant - DIRECTRX (079254320)

Establishment
Name	Address	ID/FEI	Business Operations
DIRECTRX		079254320	repack(61919-498)