SENNOSIDES AND DOCUSATE SODIUM- sennosides, docusate sodium tablet

SPL UNCLASSIFIED SECTION

Drug Facts
Active ingredient (in each tablet)

Docusate Sodium 50mg

Sennosides 8.6 mg
Purpose

Stool softener

Stimulant laxative
Uses
- relieves occasional constipation (irregularity)
- generally causes bowel movement in 6-12 hours
Warnings
Do not use
- this product if you are presently taking mineral oil, unless directed by a doctor
- laxative products for longer than 1 week unless directed by a doctor
Ask a doctor before use if you have
- stomach pain
- nausea
- vomiting
- a sudden change in bowel movements that presists over 2 weeks
STOP USE

Stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after use if a laxative. These could be signs of a serious condition.
PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children.

In case of overdose, get medical help or contacnt a Posion Control Center right away.

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 does by one tablet (do not exceed maximum dosage) or decrease does until you are comfortable

age	starting dosage	maximum dosage
adults and children 12 years of age and older	2 tablets once a day	4 tablets twice a day
children 6 to 12 years	1 tablet once a day	2 tablets twice a day
children 2 to 6 years	1/2 tablet once a day	1 tablet twice a day
children under 2 years	ask a doctor	ask a doctor

Other information
- each tablet contains: calcium 20 mg, sodium 6 mg (LOW SODIUM)
- store at 25°C (77°F) excursions permitted between 15°30°C (59°-86°F)
Inactive ingredients

carnauba was, collodial silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminmum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium benzoate, stearic acid, titanium dioxide
Questions or comments?

Call 516-341-0666, 8:30 am - 4:30 pm ET, Monday - Friday
PRINCIPAL DISPLAY PANEL

NDC: 69618-049-01

SENNA PLUS

Sennosides 8.6 mg

Docusate Sodium 50 mg

NATURAL VEGETABLE

LAXATIVE AND STOOL SOFTNER

100 TABLETS

*Compate to the active ingredients in SENOKOT-S®

INGREDIENTS AND APPEARANCE

SENNOSIDES AND DOCUSATE SODIUM
sennosides, docusate sodium tablet

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

Ingredient Name	Strength
Inactive Ingredients
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CARNAUBA WAX (UNII: R12CBM0EIZ)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SODIUM BENZOATE (UNII: OJ245FE5EU)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 69618-049-01	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/01/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	08/01/2018

Labeler - Reliable-1 Laboratories LLC (079718111)

Sennosides and Docusate Sodium by