STOOL SOFTENER- docusate sodium capsule, liquid filled

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

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Active ingredient:
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)
Available from:
Geri-Care Pharmaceutical Corp
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Stool Softener Laxative - relieves occasional constipation (irregularity) - generally produces bowel movement in 12 to 72 hours
Authorization status:
OTC monograph not final
Authorization number:
57896-426-01

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STOOL SOFTENER- docusate sodium capsule, liquid filled

Geri-Care Pharmaceutical Corp

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.

----------

gc425 (426)

Active ingredient (in each softgel)

Docusate Sodium 250 mg

Purpos e

Stool Softener Laxative

Us es

relieves occasional constipation (irregularity)

generally produces bowel movement in 12 to 72 hours

Warnings

Ask a doctor before use if you

have stomach pain, nausea, or vomiting

have a sudden change in bowel habits that persists over a period of 2 weeks

are presently taking mineral oil

Stop use and ask a doctor if

you need to use a laxative longer than 1 week

you have rectal bleeding or fail to have a bowel movement.

These could be signs of 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

adults and children 12 years and older: take 1 softgel daily or as directed by a doctor

children under 12: do not use

do not exceed recommended dose

Other information

each softgel contains: sodium 15 mg

store at 59°-77°F (15°-25°C)

keep tightly closed

product of Romania

Package not child resistant

Tamper Evident: Do not use if imprinted seal under cap is missing or broken

Inactive ingredients

FD&C red #40, FD&C yellow #6 (sunset yellow),

gelatin, glycerol, PEG, purified water

Questions or comments?

1-800-540-3765

package Label

STOOL SOFTENER

docusate sodium capsule, liquid filled

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:578 9 6 -426

Route of Administration

ORAL

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

250 mg

Inactive Ingredients

Ingredient Name

Stre ng th

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

GELATIN (UNII: 2G8 6 QN327L)

GLYCERIN (UNII: PDC6 A3C0 OX)

WATER (UNII: 0 59 QF0 KO0 R)

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

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

Geri-Care Pharmaceutical Corp

Product Characteristics

Color

re d

S core

no sco re

S hap e

OVAL (o blo ng)

S iz e

20 mm

Flavor

Imprint Code

SCU1

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:578 9 6 -426 -0 1

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

0 4/0 1/20 20

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 4/0 1/20 20

Labeler -

Geri-Care Pharmaceutical Corp (611196254)

Registrant -

Geri-Care Pharmaceutical Corp (611196254)

Revised: 12/2020

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