SENNOSIDES- sennosides tablet, film coated

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

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Active ingredient:
SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX)
Available from:
Rugby Laboratories
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Purpose Laxative - relieves occasional constipation (irregularity)  - generally produces bowel movement in 6-12 hours
Authorization status:
OTC monograph not final
Authorization number:
0536-1168-01, 0536-1168-10

SENNOSIDES- sennosides tablet, film coated

Rugby Laboratories

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.

----------

1122-Rugby

Drug Facts

Active ingredient (in each tablet)

Sennosides 8.6 mg

Purpose

Laxative

Uses

relieves occasional constipation (irregularity)

generally produces bowel movement in 6-12 hours

Do not use

laxative products for longer than one 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 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 25 mg

each tablet contains: sodium 1 mg (VERY LOW SODIUM)

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

croscarmellose sodium, dicalcium phosphate, hypromellose, magnesium stearate, maltodextrin,

microcrystalline cellulose, mineral oil, polyethylene glycol and talc

Questions or comments?

1-800-645-2158

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

SAVE CARTON FOR COMPLETE DRUG FACTS

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

BROKEN OR MISSING

Distributed by: Rugby Laboratories

17177 N Laurel Park Dr., Suite 233,

Livonia, MI 48152

www.rugbylaboratories.com

Rugby

NDC 0536-1168-01

COMPARE TO THE ACTIVE INGREDIENT IN SENOKOT®*

Standardized Senna Concentrate

Sennosides 8.6 mg

SENEXON

Natural Vegetable Stimulant Ingredient

Laxative

100 Tablets

®

®

SENNOSIDES

sennosides tablet, film coated

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:0 536 -116 8

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

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

SENNOSIDES

8 .6 mg

Rugby Laboratories

Inactive Ingredients

Ingredient Name

Stre ng th

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

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

HYPRO MELLO SES (UNII: 3NXW29 V3WO)

TALC (UNII: 7SEV7J4R1U)

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

CRO SCARMELLO SE SO DIUM (UNII: M28 OL1HH48 )

MALTO DEXTRIN (UNII: 7CVR7L4A2D)

MICRO CRYSTALLINE CELLULO SE (UNII: OP1R32D6 1U)

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

Product Characteristics

Color

bro wn

S core

no sco re

S hap e

ROUND

S iz e

9 mm

Flavor

Imprint Code

1122;1122

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 536 -116 8 -10

10 0 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 2/14/20 19

2

NDC:0 536 -116 8 -0 1

1 in 1 CARTON

0 1/23/20 19

2

10 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt334

0 1/23/20 19

Labeler -

Rugby Laboratories (079246066)

Revised: 5/2019

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