SENNA AND DOCUSATE SODIUM tablet, film coated

Senna and Docusate Sodium by

Drug Labeling and Warnings

Senna and Docusate Sodium by is a Otc medication manufactured, distributed, or labeled by Sunrise Pharmaceutical Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 25°C (77°F); 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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SENNA AND DOCUSATE SODIUM 
senna and docusate sodium tablet, film coated

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

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

Inactive Ingredients
Ingredient Name	Strength
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	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	S134
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11534-134-60	60 in 1 BOTTLE
2	NDC: 11534-134-05	57603 in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	07/26/2007

Labeler - Sunrise Pharmaceutical Inc (168522378)