SENNOSIDES AND 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 Cardinal Health 107, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients(in each tablet)

Docusate Sodium         50 mg
Sennosides            8.6 mg

Purpose

Stool softener
Laxative

Uses

• relieves occasional constipation (irregularity)
• this product generally produces a bowel movement in 6 to 12 hours

Warnings

Do not use

• if you are now 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 or vomiting
• noticed a sudden change in bowel habits that lasts over two weeks

Stop use and ask a doctor if

you have rectal bleeding or fail to have a bowel movement after use of a laxative.
These may indicate 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

• do not exceed 8 tablets in 24 hours
• Adults and children 12 years of age and older take 2 tablets once a day preferably at bedtime; increase as needed, or as directed by a doctor; the maximum dose should be 4 tablets in the morning and 4 tablets at bedtime
• Children under 12 years ask a doctor

Other information

• each tablet contains: calcium 20 mg, sodium 3 mg. Very low sodium.
• store at 20°-25°C (68°-77°F); excursions permitted between 15°-30°C (59°-86°F).
• FOR YOUR PROTECTION: Do not use if blister is torn or broken.

Inactive ingredients

cellulose, croscarmellose sodium, dicalcium phosphate, FD&C yellow #6 lake, hypromellose, magnesium stearate, PEG, silica, talc, titanium dioxide.

SPL UNCLASSIFIED SECTION

The drug product contained in this package is from Geri-Care Pharmaceuticals Corp.

Distributed by:
American Health Packaging, Columbus, Ohio 43217         Product of India

Overbagged with 10 tablets per bag, NDC: 55154-2578-0

WARNING: This Unit Dose package is not child resistant and is Intended for Institutional Use Only. Keep this and all drugs out of the reach of children.

Distributed By:

Cardinal Health

Dublin, OH 43017

L58458880724

762201
0462201/0825

Principal Display Panel

NDC: 55154-2578-0

Sennosides* and Docusate Sodium Tablets

Natural Vegetable Laxative with Stool Softener

8.6 mg / 50 mg

10 TABLETS

INGREDIENTS AND APPEARANCE

SENNOSIDES AND DOCUSATE SODIUM 
sennosides and docusate sodium tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55154-2578(NDC:60687-622)
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
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
FD&C YELLOW NO. 6 ALUMINUM LAKE (UNII: GYP6Z2JR6Q)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	ORANGE	Score	no score
Shape	ROUND	Size	9mm
Flavor		Imprint Code	PSD22
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55154-2578-0	10 in 1 BAG	08/03/2021
1		1 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M007	08/03/2021

Labeler - Cardinal Health 107, LLC (118546603)