PHILLIPS STOOL SOFTENER BULK DOCUSATE- docusate sodium capsule, liquid filled
Bayer HealthCare LLC.

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Phillips ®' Stool Softener Liquid Gels

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

Do not use if you have ever had an allergic reaction to this product or any of its ingredients.

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

PHILIPS_Stoolsoftener_DS_LiquidGel_30ct_Tab_Crtn

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

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

Ingredient Name	Strength
Inactive Ingredients
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)
SORBITOL (UNII: 506T60A25R)
SORBITAN (UNII: 6O92ICV9RU)

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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M007	09/02/2013	12/01/2023

Labeler - Bayer HealthCare LLC. (112117283)

Revised: 11/2023

Document Id: 0b61f06f-ec5c-c6db-e063-6394a90a724e

Set id: b0462555-5554-4a17-a1fe-4206a4fd350d

Version: 12

Effective Time: 20231130

Bayer HealthCare LLC.