STOOL SOFTENER- docusate sodium tablet

STOOL SOFTENER by

Drug Labeling and Warnings

STOOL SOFTENER by is a Otc medication manufactured, distributed, or labeled by Geri-Care Pharmaceuticals, Corp, GCP Laboratories. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Docusate Sodium 100 mg

Purpose

Stool Softener Laxative

Uses

• 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

Keep out of the 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 1-3 tablets daily until first bowel movement; 1 tablet daily thereafter, or as directed by doctor
• children under 12: consult a doctor
• do not exceed recommended dose

Other information

• each tablet contains: calcium 50 mg, sodium 8 mg
• store at room temperature 15°C-30°C (59°F-86°F)
• Tamper Evident: Do not use if imprinted seal under cap is missing or broken

Inactive ingredients

cellulose, croscarmellose sodium, dicalcium phosphate, magnesium stearate, silica, stearic acid, talc

Questions or comments?

1-800-540-3765

PACKAGE LABEL

INGREDIENTS AND APPEARANCE

STOOL SOFTENER 
docusate sodium tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57896-421(NDC: 75841-421)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)	DOCUSATE SODIUM	100 mg

Inactive Ingredients
Ingredient Name	Strength
STEARIC ACID (UNII: 4ELV7Z65AP)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TALC (UNII: 7SEV7J4R1U)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	11mm
Flavor		Imprint Code	GC422
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57896-421-10	1000 in 1 BOTTLE; Type 0: Not a Combination Product	09/01/2015
2	NDC: 57896-421-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	09/01/2015
3	NDC: 57896-421-20	200 in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	09/01/2015

Labeler - Geri-Care Pharmaceuticals, Corp (611196254)

Registrant - GCP Laboratories (965480861)

Establishment
Name	Address	ID/FEI	Business Operations
GCP Laboratories		965480861	manufacture(57896-421) , relabel(57896-421)