DOCUSATE SODIUM 100MG TWO-TONE- docusate sodium capsule, liquid filled

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Preparatomtale Preparatomtale (SPC)

07-11-2019

Aktiv ingrediens:
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)
Tilgjengelig fra:
Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.
INN (International Name):
DOCUSATE SODIUM
Sammensetning:
DOCUSATE SODIUM 100 mg
Administreringsrute:
ORAL
Resept typen:
OTC DRUG
Indikasjoner:
Stool softener  - relieves occasional constipation (irregularity) - generally produces a bowel movement in 12 to 72 hours
Autorisasjon status:
OTC monograph not final
Autorisasjonsnummer:
53345-023-02

DOCUSATE SODIUM 100MG TWO-TONE- docusate sodium capsule, liquid filled

Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.

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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DOCUSATE SODIUM 100mg Two-Tone, Capsule, liquid filled

Drug Facts

Active ingredient (in each softgel)

Docusate Sodium 100 mg

Purpos e

Stool softener

Us es

relieves occasional constipation (irregularity)

generally produces a bowel movement in 12 to 72 hours

Warnings

Do not use

if you are presently taking mineral oil, unless told to do so by a doctor

Ask a doctor before use if you have

stomach pain

nausea

vomiting

noticed a sudden change in bowel movements that lasts over 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 could be

signs of a serious condition.

you need to use a stool softener laxative for more than 1 week

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 only by mouth. Doses may be taken as a single daily dose or in divided doses.

adults and children 12 years and over

take 1 to 3 softgels daily

children 2 to under 12 years of age

take 1 softgel daily

children under 2 years

ask a doctor

children under 2 years

ask a doctor

Other information

each softgel contains: sodium 5 mg

VERY LOW SODIUM

store at room temperature 15°-30°C (59°-86°F) and avoid excessive heat

Inactive ingredients

Black ink, citric acid, D&C red #33, FD&C blue #1, FD&C red #40, FD&C yellow #6, gelatin,

glycerin, polyethylene glycol, propylene glycol, sorbitol special and purified water

Manufactured by:

Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.

Wuhan, Hubei 430206,

China

PRINCIPAL DISPLAY PANEL - Shipping Label

DOCUSATE SODIUM CAPSULES, 100 mg

Quantity : 15000 Capsules

NDC. No : 53345-023-02

IMPORTANT:

Inspect immediate upon receipt.

This is a bulk shipment, intended for further processing only.

Protect from heat, humidity, and light. Do not refrigerate.

Store at 15-30°C (59-86°F)

CAUTION : FOR FURTHER MANUFACTURING, PROCESSING OR REPACKAGING

DOCUSATE SODIUM 100MG TWO-TONE

docusate sodium capsule, liquid filled

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:53345-0 23

Route of Administration

ORAL

Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.

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

10 0 mg

Inactive Ingredients

Ingredient Name

Stre ng th

ANHYDRO US CITRIC ACID (UNII: XF417D3PSL)

D&C RED NO . 3 3 (UNII: 9 DBA0 SBB0 L)

FD&C BLUE NO . 1 (UNII: H3R47K3TBD)

FD&C RED NO . 4 0 (UNII: WZB9 127XOA)

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

GELATIN (UNII: 2G8 6 QN327L)

GLYCERIN (UNII: PDC6 A3C0 OX)

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

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

SO RBITO L (UNII: 50 6 T6 0 A25R)

WATER (UNII: 0 59 QF0 KO0 R)

Product Characteristics

Color

red, white

S core

no sco re

S hap e

CAPSULE (OVAL)

S iz e

13mm

Flavor

Imprint Code

6 57

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:53345-0 23-0 2

1 in 1 BOX

0 4/10 /20 15

1

150 0 0 in 1 BAG; 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 4/10 /20 15

Labeler -

Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd. (421293287)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Humanwell PuraCap Pharmaceutical (Wuhan) Co ., Ltd.

42129 328 7

MANUFACTURE(53345-0 23) , ANALYSIS(53345-0 23)

Revised: 11/2019

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