PHILLIPS STOOL SOFTENER BULK DOCUSATE- docusate sodium capsule, liquid filled

Phillips Stool Softener by

Drug Labeling and Warnings

Phillips Stool Softener by is a Otc medication manufactured, distributed, or labeled by Bayer HealthCare LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each softgel)

Docusate sodium 100 mg

Purpose

Stool softener laxative

Use

• for relief of occasional constipation (irregularity)
• this product generally produces a bowel movement in 12 to 72 hours

Warnings

Ask a doctor before use if you have

• stomach pain, nausea, or vomiting
• a sudden change in bowel habits that lasts over 14 days

Ask a doctor or pharmacist before use if you are presently taking mineral oil

Stop use and ask a doctor if

• you have rectal bleeding or no bowel movement after using this product. These could be signs of a serious condition.
• you need to use a 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 softgels with a full glass (8 oz) of water

• adults and children 12 years and older: take 1 to 3 softgels daily or as directed by a doctor. This dose may be taken as a single daily dose or in divided doses.
• children 6 to under 12 years: take 1 softgel daily or as directed by a doctor
• children under 6 years of age: ask a doctor

Other information

• each softgel contains: sodium 6 mg
• very low sodium
• store at room temperature. Avoid excessive heat 40°C (104°F).

Inactive ingredients

FD&C blue #1, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sodium hydroxide, sorbitol sorbitan solution, titanium dioxide

Questions or comments?

1-800-986-0369 (Mon – Fri 9AM – 5PM EST) or www.bayercare.com

PRINCIPAL DISPLAY PANEL - 30 Capsule Carton

INGREDIENTS AND APPEARANCE

PHILLIPS STOOL SOFTENER  BULK DOCUSATE
docusate sodium capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0280-1012
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
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SHELLAC (UNII: 46N107B71O)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)

Product Characteristics
Color	red	Score	no score
Shape	OVAL	Size	4mm
Flavor		Imprint Code	P10
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0280-1012-30	1 in 1 CARTON	05/19/2015
1		30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC: 0280-1012-60	1 in 1 CARTON	05/19/2015
2		60 in 1 BOTTLE, PLASTIC; 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	09/02/2013

Labeler - Bayer HealthCare LLC. (112117283)