SENNOSIDES AND DOCUSATE SODIUM- sennosides, docusate sodium tablet

Sennosides and Docusate Sodium by

Drug Labeling and Warnings

Sennosides and Docusate Sodium by is a Otc medication manufactured, distributed, or labeled by Asclemed USA, Inc., ASCLEMED USA INC. DBA ENOVACHEM. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drugs Facts

Active ingredient (in each tablet)

Docusate sodium 50 mg

Sennosides 8.6 mg

Purpose

Stool softener

Stimulant laxative

Uses

relieves occasional constipation (irregularity)

generally produces a bowel movement in 6 to 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

Warnings

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

Warnings

Stop use and ask a doctor ifyou have rectal bleeding or fail to have bowel movement after use of a laxative. These may indicate a serious condition.

Warnings

If pregnant or breast-feeding,ask a health professional before use.

Warnings

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

do not exceed maximum dosage

age	starting dosage	maximun dosage
adults and children 12 years of age or older	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

Other information

each tablet contains: calcium 4 mg, sodium 8 mg

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

Inactive ingredients

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

Questions or comments?

Call 516-341-0666

8:30am-4:30pm ET, Mon-Fri

SPL UNCLASSIFIED SECTION

Repackaged and Relabeled by:
Enovachem PHARMACEUTICALS
Torrance, CA 90501

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SENNOSIDES AND DOCUSATE SODIUM 
sennosides, docusate sodium tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76420-918(NDC:69618-065)
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
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SODIUM BENZOATE (UNII: OJ245FE5EU)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
HYPROMELLOSES (UNII: 3NXW29V3WO)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76420-918-30	30 in 1 BOTTLE; Type 0: Not a Combination Product	02/08/2025
2	NDC: 76420-918-60	60 in 1 BOTTLE; Type 0: Not a Combination Product	02/08/2025
3	NDC: 76420-918-90	90 in 1 BOTTLE; Type 0: Not a Combination Product	02/08/2025
4	NDC: 76420-918-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	02/08/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M007	08/01/2020

Labeler - Asclemed USA, Inc. (059888437)

Establishment
Name	Address	ID/FEI	Business Operations
ASCLEMED USA INC. DBA ENOVACHEM		059888437	relabel(76420-918) , repack(76420-918)