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:
H E B
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Stimulant Laxative - relieves occasional constipation (irregularity) - generally produces a bowel movement in 6-12 hours
Authorization status:
OTC monograph not final
Authorization number:
37808-731-01

SENNA LAXATIVE- sennosides tablet

H E B

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.

----------

Drug Facts

Active ingredient (in each tablet)

Sennosides 8.6 mg

Purpos e

Stimulant Laxative

Us es

relieves occasional constipation (irregularity)

generally produces a bowel movement in 6-12 hours

Warnings

Do not use

laxative products for longer than 1 week unless directed by a doctor

Ask a doctor before using 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

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 tablet once a day

2 tablets twice a day

children 2 to under 6 years

1/2 tablets once a day

1 tablet twice a day

children under 2 years

ask a doctor

ask a doctor

Other information

each tablet contains: calcium 30 mg

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

Inactive Ingredients

croscarmellose sodium, dibasic calcium phosphate dihydrate, hypromellose*, magnesium stearate,

microcrystalline cellulose, mineral oil*, silicon dioxide*, sodium lauryl sulfate*, stearic acid*, talc*,

triacetin*

*contains one or more of these ingredients

Questions or comments?

Call toll-free: 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Compare to Senokot® active ingredient**

Senna Laxative

Sennosides, 8.6 mg

Stimulant Laxative

TABLETS

**This product is not manufactured or distributed by Aviro Health L.P., distributor of Senokot®.

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

OR MISSING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

MADE WITH PRIDE AND CARE FOR H-E-B®, SAN ANTONIO, TX 78204

Product Label

H-E-B Senna Laxative

SENNA LAXATIVE

sennosides tablet

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:378 0 8 -731

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

Inactive Ingredients

Ingredient Name

Stre ng th

TRIACETIN (UNII: XHX3C3X6 73)

CRO SCARMELLO SE SO DIUM (UNII: M28 OL1HH48 )

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

HYPRO MELLO SES (UNII: 3NXW29 V3WO)

MINERAL O IL (UNII: T5L8 T28 FGP)

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

CELLULO SE, MICRO CRYSTALLINE (UNII: OP1R32D6 1U)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

SO DIUM LAURYL SULFATE (UNII: 36 8 GB5141J)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

TALC (UNII: 7SEV7J4R1U)

Product Characteristics

Color

BROWN

S core

no sco re

S hap e

ROUND

S iz e

9 mm

Flavor

Imprint Code

TCL0 8 0 ;PS23;S8

Contains

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:378 0 8 -731-

1 in 1 BOX

0 2/28 /20 19

1

10 0 in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

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

0 2/28 /20 19

H E B

Labeler -

H E B (007924756)

Revised: 1/2020

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