SENNA LAXATIVE- sennosides tablet

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

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Active ingredient:
SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX)
Available from:
Bryant Ranch Prepack
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Laxative - this product generally produces a bowel movement in 6 to 12 hours - relieves occasional constipation (irregularity)
Product summary:
Product: 71335-1261 NDC: 71335-1261-1 100 TABLET in a BOTTLE NDC: 71335-1261-2 60 TABLET in a BOTTLE NDC: 71335-1261-3 120 TABLET in a BOTTLE NDC: 71335-1261-4 56 TABLET in a BOTTLE NDC: 71335-1261-5 30 TABLET in a BOTTLE NDC: 71335-1261-6 90 TABLET in a BOTTLE NDC: 71335-1261-7 10 TABLET in a BOTTLE
Authorization status:
OTC monograph not final
Authorization number:
71335-1261-1, 71335-1261-2, 71335-1261-3, 71335-1261-4, 71335-1261-5, 71335-1261-6, 71335-1261-7

SENNA LAXATIVE- sennosides tablet

Bryant Ranch Prepack

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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sunmark 451

Active ingredient (in each tablet)

Sennosides 8.6 mg

Purpos e

Laxative

Us es

this product generally produces a bowel movement in 6 to 12 hours

relieves occasional constipation (irregularity)

Warnings

Do not use for more than one week unless directed by a doctor.

Ask a doctor before use if you

have abdominal pain, nausea or vomiting

have 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

Age

Starting Dose

Maximum Dose

adults and children 12

years of age and older

2 tablets once a day preferably at bedtime;

increase as needed, or as directed by a doctor

4 tablets in the morning

and 4 tablets at bedtime

children under 12 years

ask a doctor

Other information

each tablet contains: calcium 40 mg

store at room temperature 15-30C (59-86F)

Inactive ingredients

cellulose, croscarmellose sodium, dicalcium phosphate, hypromellose*, magnesium silicate*,

magnesium stearate, mineral oil*, PEG*, silica*, wax*.

*May contain these ingredients.

HOW SUPPLIED

Product: 71335-1261

NDC: 71335-1261-1 100 TABLET in a BOTTLE

NDC: 71335-1261-2 60 TABLET in a BOTTLE

NDC: 71335-1261-3 120 TABLET in a BOTTLE

NDC: 71335-1261-4 56 TABLET in a BOTTLE

NDC: 71335-1261-5 30 TABLET in a BOTTLE

NDC: 71335-1261-6 90 TABLET in a BOTTLE

NDC: 71335-1261-7 10 TABLET in a BOTTLE

Sennosides 8.6mg Tablet

SENNA LAXATIVE

sennosides tablet

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:71335-126 1(NDC:70 6 77-0 0 58 )

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

Bryant Ranch Prepack

Inactive Ingredients

Ingredient Name

Stre ng th

MICRO CRYSTALLINE CELLULO SE (UNII: OP1R32D6 1U)

CRO SCARMELLO SE SO DIUM (UNII: M28 OL1HH48 )

ANHYDRO US DIBASIC CALCIUM PHO SPHATE (UNII: L11K75P9 2J)

MAGNESIUM SILICATE (UNII: 9 B9 6 9 1B2N9 )

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

MINERAL O IL (UNII: T5L8 T28 FGP)

PO LYETHYLENE GLYCO L, UNSPECIFIED (UNII: 3WJQ0 SDW1A)

HYPRO MELLO SE, UNSPECIFIED (UNII: 3NXW29 V3WO)

CARNAUBA WAX (UNII: R12CBM0 EIZ)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

Product Characteristics

Color

bro wn

S core

no sco re

S hap e

ROUND

S iz e

8 mm

Flavor

Imprint Code

AZ217

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:71335-126 1-1

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

0 7/0 2/20 19

2

NDC:71335-126 1-2

6 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 7/0 2/20 19

3

NDC:71335-126 1-3

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

0 7/0 2/20 19

4

NDC:71335-126 1-4

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

0 7/0 2/20 19

5

NDC:71335-126 1-5

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

0 7/0 2/20 19

6

NDC:71335-126 1-6

9 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 7/0 2/20 19

7

NDC:71335-126 1-7

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

0 7/0 2/20 19

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

10 /0 1/20 18

Labeler -

Bryant Ranch Prepack (171714327)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Bryant Ranch Prepack

171714327

REPACK(71335-126 1) , RELABEL(71335-126 1)

Revised: 9/2020

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