Senna and docusate sodium tablet, film coated

Otc - active ingredient

Docusate sodium 50 mg, Sennoside 8.6 mg.

Otc - purpose

Stimulant laxative.

Indications and usage

For temporary relief of occasional constipation and irregularity.

This product generally produces bowel movement in 6 to 12 hours.

Warnings

Do not use:

laxative products for longer than 1 week unless told to do so by a doctor.

if you are presently taking mineral oil, unless told to do so by a doctor

Otc - ask doctor

Before use if you have:

Stomach pain, nausea or vomiting

Noticed a sudden change in bowel habits that lasts over 2 weeks.

Otc - stop use

If you have rectal bleeding or fail to have bowel movement after use of a laxative. This could be a serious condition.

Otc - pregnancy or breast feeding

Ask a health professional before use.

Otc - keep out of reach of children

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

Dosage and administration

Drink with a full glass of water with each dose

Adults and children 12 years and over take 2 - 4 tablets daily
Children 6 to under 12 years take 1 - 2 tablets daily
Children 2 to under 6 years take up to 1 tablet daily
Children under 2 years of age Ask a doctor

OTHER INFORMATION

Each tablet contains: calcium 30 mg, sodium 3 mg VERY LOW SODIUM.

Do not use if the imprinted safety seal under cap is missing or damaged.

Store at at 25C (77F); excursions permitted between 15(-30(C (59(-86(F)

Keep tightly closed.

Inactive ingredient

Colloidal silicon dioxide, dicalcium phosphate, ethanol, FD&C blue #2, FD&C red #40, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil, polyethylene glycol, pregelatinized starch, silicon dioxide, sodium benzoate, stearic acid, titanium dioxide.

Ingredients and appearance - Product information

Senna and docusate sodium tablet, film coated- Senna and docusate sodium

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 11534-134
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Docusate sodium ( UNII: F05Q2T2JA0)( Docusate - UNII: M7P27195AG ) 50 mgin 1
Sennosides ( UNII: 3FYP5M0IJX)( Sennosides - UNII: 3FYP5M0IJX ) 8.6 mgin 1

Inactive Ingredients

Ingredient Name Code
Dibasic calcium phosphate dihydrate ( UNII: O7TSZ97GEP)
Silicon dioxide ( UNII: ETJ7Z6XBU4)
Alcohol ( UNII: 3K9958V90M)
Fd&c blue no. 2 ( UNII: L06K8R7DQK)
Fd&c red no. 40 ( UNII: WZB9127XOA)
Hypromellose 2208 (100 mpa.s) ( UNII: B1QE5P712K)
Magnesium stearate ( UNII: 70097M6I30)
Cellulose, microcrystalline ( UNII: OP1R32D61U)
Mineral oil ( UNII: T5L8T28FGP)
Polyethylene glycols ( UNII: 3WJQ0SDW1A)
Starch, corn ( UNII: O8232NY3SJ)
Sodium benzoate ( UNII: OJ245FE5EU)
Stearic acid ( UNII: 4ELV7Z65AP)
Titanium dioxide ( UNII: 15FIX9V2JP)

Product Characteristics

Color RED Imprint Code S134
Shape ROUND Score 1
Size 10 mm

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC monograph not final part334 USA

Labeler - Sunrise Pharmaceutical Inc( 168522378)

Package label.principal display panel