SENNOSIDES AND DOCUSATE SODIUM-sennosides, docusate sodium tabletMarlexPharmaceuticals, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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SennaS

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 persists over 2 weeks

Stop use and ask a doctorif

you have rectal bleeding or fail to have a bowel movement after use if a laxative. These could be signs of a serious condition.

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 contact a Poison 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 4mg, sodium 8mg
store at 20°C to 25°C (68°F to 77°F) excursions permitted between 15°30°C (59°-86°F)

Inactive ingredients

Colloidal silicon dioxide, croscarmellose sodium, D&C Yellow #10 Aluminum Lake, FD&C Yellow #6 Aluminum Lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium benzoate, titanium dioxide

*Compare to the active ingredients in SENOKOT-S®

PRINCIPAL DISPLAY PANEL

NDC 10135-0669-01
Senna S
100 TABLET

669-01

SENNA S
docusate sodium and sennosides tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:10135-669
Route of Administration	ORAL

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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
SODIUM BENZOATE (UNII: OJ245FE5EU)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	orange	Score	no score
Shape	ROUND	Size	9mm
Flavor		Imprint Code	S6
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:10135-669-01	1 in 1 CARTON	10/01/2018
1		100 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M007	10/01/2018

Labeler - Marlex Pharmaceuticals Inc (782540215)