DULCOEASE- docusate sodium capsule, liquid filled

DulcoEase by

Drug Labeling and Warnings

DulcoEase by is a Otc medication manufactured, distributed, or labeled by Boehringer Ingelheim Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Drug Facts

• Active ingredient (in each capsule): Purpose
• Docusate sodium (USP) 100 mg: Stool softener laxative

WHEN USING

Use

• for temporary relief of occasional constipation and irregularity
• this product generally produces bowel movement in 12 to 72 hours

ASK DOCTOR

Warnings

Ask a doctor before use if you have

• stomach pain, nausea or vomiting
• a sudden change in bowel habits that lasts more than 2 weeks

ASK DOCTOR/PHARMACIST

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

STOP USE

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

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

PURPOSE

Directions take with a glass of water

• adults and children 12 years of age and over: 1 to 3 capsules daily. This dose may be taken as a single daily dose or in divided doses.
• children 2 to under 12 years of age: 1 capsule daily
• children under 2 years of age: ask a doctor

DOSAGE FORMS & STRENGTHS

Other information

• each capsule contains: sodium 6 mg
• store at 20-25°C (68-77°F)
• protect from excessive humidity
• do not use this product if the safety seal under the cap is torn or missing

INACTIVE INGREDIENT

Inactive ingredients

FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, hypromellose, isopropyl alcohol, mannitol, polyethylene glycol 400, propylene glycol, sorbitan, sorbitol, titanium dioxide, water

QUESTIONS

Questions? Call 1-888-285-9159 (English/Spanish) M – F, 8:30 – 5 EST, or visit www.Dulcolax.com

Distributed by: Boehringer Ingelheim (BI) Consumer Health Care Products Division of BI Pharmaceuticals, Inc., Ridgefield, CT 06877. © 2016, BI Pharmaceuticals, Inc. All rights reserved.

INDICATIONS & USAGE

WARNINGS AND PRECAUTIONS

DOSAGE & ADMINISTRATION

WARNINGS

PRINCIPAL DISPLAY PANEL

DulcoEase® 25 Capsules
NDC: 0597-0330-28

INGREDIENTS AND APPEARANCE

DULCOEASE 
docusate sodium capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0597-0330
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)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
HYPROMELLOSES (UNII: 3NXW29V3WO)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
MANNITOL (UNII: 3OWL53L36A)
SORBITAN (UNII: 6O92ICV9RU)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	RED	Score	no score
Shape	OVAL	Size	10mm
Flavor		Imprint Code	DE;100
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0597-0330-28	1 in 1 CARTON	07/01/2016
1		25 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 0597-0330-83	1 in 1 CARTON	07/01/2016
2		50 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 0597-0330-01	1 in 1 CARTON	07/01/2016
3		100 in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC: 0597-0330-89	1 in 1 CARTON	07/01/2016
4		180 in 1 BOTTLE; Type 0: Not a Combination Product
5	NDC: 0597-0330-57	1 in 1 CARTON	07/01/2016
5		30 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	07/01/2016

Labeler - Boehringer Ingelheim Pharmaceuticals, Inc. (603175944)

Registrant - Boehringer Ingelheim Pharmaceuticals, Inc. (603175944)