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

United States - English - NLM (National Library of Medicine)

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Active ingredient:
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG), SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX)
Available from:
NCS HealthCare of KY, Inc dba Vangard Labs
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Purposes Laxative Stool softener - relieves occasional constipation (irregularity) - generally produces bowel movement in 6-12 hours
Authorization status:
OTC monograph not final
Authorization number:
0615-8276-39

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

NCS HealthCare of KY, Inc dba Vangard Labs

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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0490C-Rugby

Drug Facts

Active ingredients (in each tablet)

Sennosides 8.6 mg

Docusate sodium 50 mg

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 of age 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 tablet 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 ingredients

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

TAMPER EVIDENT

*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

SENNOSIDES,DOCUSATE SODIUM

sennosides,docusate sodium tablet, film coated

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:0 6 15-8 276 (NDC:0 536 -116 9 )

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

DO CUSATE SO DIUM (UNII: F0 5Q2T2JA0 ) (DOCUSATE - UNII:M7P2719 5AG)

DOCUSATE SODIUM

50 mg

SENNO SIDES (UNII: 3FYP5M0 IJX) (SENNOSIDES - UNII:3FYP5M0 IJX)

SENNOSIDES

8 .6 mg

Inactive Ingredients

Ingredient Name

Stre ng th

FD&C YELLO W NO . 6 (UNII: H77VEI9 3A8 )

LIGHT MINERAL O IL (UNII: N6 K578 7QVP)

TALC (UNII: 7SEV7J4R1U)

NCS HealthCare of KY, Inc dba Vangard Labs

CRO SCARMELLO SE SO DIUM (UNII: M28 OL1HH48 )

CALCIUM PHO SPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ9 7GEP)

HYPRO MELLO SES (UNII: 3NXW29 V3WO)

MICRO CRYSTALLINE CELLULO SE (UNII: OP1R32D6 1U)

SO DIUM LAURYL SULFATE (UNII: 36 8 GB5141J)

STARCH, CO RN (UNII: O8 232NY3SJ)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

FD&C YELLO W NO . 5 (UNII: I753WB2F1M)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

TRIACETIN (UNII: XHX3C3X6 73)

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

MALTO DEXTRIN (UNII: 7CVR7L4A2D)

SO DIUM BENZO ATE (UNII: OJ245FE5EU)

PO LYETHYLENE GLYCO L 4 0 0 (UNII: B6 9 78 9 4SGQ)

Product Characteristics

Color

YELLOW

S core

no sco re

S hap e

ROUND

S iz e

10 mm

Flavor

Imprint Code

CPC;49 0

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date Marketing End Date

1

NDC:0 6 15-8 276 -

30 in 1 BLISTER PACK; Type 0 : No t a Co mbinatio n Pro duct

0 2/22/20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation Marke ting Start Date

Marke ting End Date

OTC MONOGRAPH NOT FINAL part334

12/20 /20 18

Labeler -

NCS HealthCare of KY, Inc dba Vangard Labs (050052943)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

NCS HealthCare o f KY, Inc dba Vangard Labs

0 50 0 529 43

REPACK(0 6 15-8 276 )

Revised: 3/2019

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