SENNOSIDES,DOCUSATE SODIUM tablet, film coated

Sennosides,Docusate sodium by

Drug Labeling and Warnings

Sennosides,Docusate sodium by is a Otc medication manufactured, distributed, or labeled by REMEDYREPACK INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients (in each tablet)

Sennosides 8.6 mg

Docusate sodium 50 mg

PURPOSE

Purposes

Laxative

Stool softener

Uses

• relieves occasional constipation (irregularity)
• generally produces bowel movement in 6-12 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

■ vomiting

■ noticed a sudden change in bowel habits that continues over a period of 2 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

• take preferably at bedtime or as directed by a doctor

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

Other information

■ each tablet contains: calcium 11 mg

■ each tablet contains: sodium 4 mg

■ store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)

INACTIVE INGREDIENT

croscarmellose sodium, dicalcium phosphate, FD&C yellow #5 lake†, FD&C yellow #6 lake, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, mineral oil, polyethylene glycol, sodium benzoate, sodium lauryl sulfate, starch, stearic acid, talc, titanium dioxide and triacetin

†contains FD&C yellow #5 lake (tartrazine) as a color additive.

Questions or comments?

1-800-645-2158

SPL UNCLASSIFIED SECTION

This is a bulk package. Dispense contents with a child-resistant closure in a tight, light-resistant container as defined in the USP.

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

*Rugby Laboratories is not affiliated with the owner of the registered trademark Senokot-S.®

Distributed by: Rugby Laboratories

17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152

www.rugbylaboratories.com

PRINCIPAL DISPLAY PANEL

DRUG: Sennosides,Docusate sodium

GENERIC: Sennosides,Docusate sodium

DOSAGE: TABLET, FILM COATED

ADMINSTRATION: ORAL

NDC: 70518-1885-0

COLOR: yellow

SHAPE: ROUND

SCORE: No score

SIZE: 10 mm

IMPRINT: CPC;490

PACKAGING: 30 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

• DOCUSATE SODIUM 50mg in 1
• SENNOSIDES 8.6mg in 1

INACTIVE INGREDIENT(S):

• FD&C YELLOW NO. 5
• TITANIUM DIOXIDE
• FD&C YELLOW NO. 6
• TRIACETIN
• MAGNESIUM STEARATE
• SODIUM BENZOATE
• MALTODEXTRIN
• STEARIC ACID
• POLYETHYLENE GLYCOL 400
• CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE
• TALC
• CROSCARMELLOSE SODIUM
• LIGHT MINERAL OIL
• HYPROMELLOSES
• MICROCRYSTALLINE CELLULOSE
• SODIUM LAURYL SULFATE
• STARCH, CORN

INGREDIENTS AND APPEARANCE

SENNOSIDES,DOCUSATE SODIUM 
sennosides,docusate sodium tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70518-1885(NDC:0536-1169)
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
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
TALC (UNII: 7SEV7J4R1U)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIACETIN (UNII: XHX3C3X673)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
SODIUM BENZOATE (UNII: OJ245FE5EU)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)

Product Characteristics
Color	yellow	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	CPC;490
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70518-1885-0	30 in 1 BLISTER PACK; Type 0: Not a Combination Product	02/20/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	02/20/2019

Labeler - REMEDYREPACK INC. (829572556)