STOOL SOFTENER- docusate sodium tablet

STOOL SOFTENER by

Drug Labeling and Warnings

STOOL SOFTENER by is a Otc medication manufactured, distributed, or labeled by STRATEGIC SOURCING SERVICES LLC, 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 1-2 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
• for institutional use only
• package not child resistant
• 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

PACKAGE LABEL

Sunmark

COMPARE TO COLACE®
ACTIVE INGREDIENT*

NDC: 49348-167-10

Stool Softener

For relief of occasional constipation

Docusate Sodium 100 mg

100 Tablets

INGREDIENTS AND APPEARANCE

STOOL SOFTENER 
docusate sodium tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49348-167(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: 49348-167-10	1 in 1 CARTON	03/01/2016
1		100 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	03/01/2016

Labeler - STRATEGIC SOURCING SERVICES LLC (116956644)

Registrant - GCP Laboratories (965480861)

Establishment
Name	Address	ID/FEI	Business Operations
GCP Laboratories		965480861	manufacture(49348-167) , relabel(49348-167)