STOOL SOFTENER- docusate sodium capsule, liquid filled

Stool Softener by

Drug Labeling and Warnings

Stool Softener by is a Otc medication manufactured, distributed, or labeled by Bryant Ranch Prepack. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each softgel)

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. 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 softgel daily until first bowel movement; 1 softgel daily thereafter, or as directed by doctor

children under 12: consult a doctor

do not exceed recommended dose

Other information

each softgel contains: sodium 5 mg. very low sodium

store at 15°C-25°C(59° F-77° F)

keep tightly closed

product from USA or Canada

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

Inactive ingredients

FD and C red 40, gelatin, glycerin, edible ink, PEG, propylene glycol, sorbitol special, water. May also contain D and C yellow 10, FD and C yellow 6 (sunset yellow), mannitol.

HOW SUPPLIED

Product: 71335-0294

NDC: 71335-0294-0 50 CAPSULE, LIQUID FILLED in a BOTTLE

NDC: 71335-0294-1 30 CAPSULE, LIQUID FILLED in a BOTTLE

NDC: 71335-0294-2 100 CAPSULE, LIQUID FILLED in a BOTTLE

NDC: 71335-0294-3 60 CAPSULE, LIQUID FILLED in a BOTTLE

NDC: 71335-0294-4 120 CAPSULE, LIQUID FILLED in a BOTTLE

NDC: 71335-0294-5 90 CAPSULE, LIQUID FILLED in a BOTTLE

NDC: 71335-0294-6 180 CAPSULE, LIQUID FILLED in a BOTTLE

NDC: 71335-0294-7 10 CAPSULE, LIQUID FILLED in a BOTTLE

NDC: 71335-0294-8 28 CAPSULE, LIQUID FILLED in a BOTTLE

NDC: 71335-0294-9 56 CAPSULE, LIQUID FILLED in a BOTTLE

Docusate Sodium 100mg Capsule

INGREDIENTS AND APPEARANCE

STOOL SOFTENER  
docusate sodium capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71335-0294(NDC:57896-401)
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
FD&C RED NO. 40 (UNII: WZB9127XOA)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
MANNITOL (UNII: 3OWL53L36A)

Product Characteristics
Color	red (reddish)	Score	no score
Shape	OVAL	Size	12mm
Flavor		Imprint Code	SCU1
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71335-0294-0	50 in 1 BOTTLE; Type 0: Not a Combination Product	11/01/2005
2	NDC: 71335-0294-6	180 in 1 BOTTLE; Type 0: Not a Combination Product	11/01/2005
3	NDC: 71335-0294-9	56 in 1 BOTTLE; Type 0: Not a Combination Product	11/01/2005
4	NDC: 71335-0294-3	60 in 1 BOTTLE; Type 0: Not a Combination Product	11/01/2005
5	NDC: 71335-0294-4	120 in 1 BOTTLE; Type 0: Not a Combination Product	11/01/2005
6	NDC: 71335-0294-1	30 in 1 BOTTLE; Type 0: Not a Combination Product	11/01/2005
7	NDC: 71335-0294-7	10 in 1 BOTTLE; Type 0: Not a Combination Product	11/01/2005
8	NDC: 71335-0294-2	100 in 1 BOTTLE; Type 0: Not a Combination Product	11/01/2005
9	NDC: 71335-0294-8	28 in 1 BOTTLE; Type 0: Not a Combination Product	11/01/2005
10	NDC: 71335-0294-5	90 in 1 BOTTLE; Type 0: Not a Combination Product	11/01/2005

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	01/01/2000

Labeler - Bryant Ranch Prepack (171714327)

Establishment
Name	Address	ID/FEI	Business Operations
Bryant Ranch Prepack		171714327	REPACK(71335-0294) , RELABEL(71335-0294)