ONLY FOR STIMULANT 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:
O4 Global Trading Usa, Llc
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Stimulant laxative • relieves occasional constipation (irregularity) • generally causes a bowel movement in 6‐12 hours
Authorization status:
OTC monograph not final
Authorization number:
73006-112-41

ONLY FOR STIMULANT LAXATIVE- sennosides tablet

O4 Global Trading Usa, Llc

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.

----------

Only For - STIMULANT LAXATIVE

DRUG FACTS

Active ingredient (in each tablet)

Sennosides 8.6 mg

Purpose

Stimulant laxative

Uses:

relieves occasional constipation (irregularity)

generally causes 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 use if you have

stomach pain

nausea

vomiting

noticed a sudden change in bowel habits that continue 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 accidental overdose, get medical help or contact a Poison Control Center right away. Prompt

medical attention is critical for adults as well as for children even if you do not notice any signs or

symptoms.

Directions:

do not take more than directed take with full glass of water

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 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:

Store at room temperature between 20-25°C (68-77°F).

Inactive Ingredients:

Croscarmellose sodium, dibasic calcium phosphate, hydroxypropyl methyl cellulose, magnesium

stearate, microcrystalline cellulose, polyethylene glycol.

Questions Or Comments ?

1-833-665-9444.

Distributed By: O4 GLOBAL TRADING USA LLC., 2241 S Watson RD, Suite 121 Arlington, TX

76010.

www.onlyfor.com

Packaged By: Strive Pharmaceuticals Inc., East Brunswick, NJ 08816

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF A BLISTER UNIT IS

TORN, BROKEN OR SHOWS ANY SIGN OF TAMPERING

Tear along perforation push product through foil

CT2LXN4-REV.102018

Packaging

ONLY FOR STIMULANT LAXATIVE

sennosides tablet

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:730 0 6 -112

Route of Administration

ORAL

O4 Global Trading Usa, Llc

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

CRO SCARMELLO SE SO DIUM (UNII: M28 OL1HH48 )

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

HYPRO MELLO SE 2 9 10 ( 5 MPA.S) (UNII: R75537T0 T4)

MAGNESIUM PALMITO STEARATE (UNII: R4OXA9 G5BV)

MICRO CRYSTALLINE CELLULO SE 10 1 (UNII: 7T9 FYH5QMK)

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

Product Characteristics

Color

bro wn

S core

no sco re

S hap e

ROUND (Bico nvex)

S iz e

9 mm

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:730 0 6 -112-41 1 in 1 CARTON

0 3/29 /20 19

1

4 in 1 BLISTER PACK; 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 3/29 /20 19

Labeler -

O4 Global T rading Usa, Llc (081226861)

Revised: 4/2019

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