Dulcolax Pink Stool Softener (Docusate Sodium) Capsule, Liquid Filled [Chattem, Inc.] -

DULCOLAX PINK STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [CHATTEM, INC.]
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NDC	41167-0281-1, 41167-0281-2
Set ID	33fefcf1-9985-4797-9a38-8acaf3979fce
Category	HUMAN OTC DRUG LABEL
Packager	Chattem, Inc.
Generic Name
Product Class
Product Number
Application Number	PART334

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SPL UNCLASSIFIED SECTION

Dulcolax Pink®

Stool Softener

Drug Facts
Active ingredient (in each capsule)

Docusate sodium (USP) 100 mg
Purpose

Stool softener laxative
Use

● for relief of occasional constipation and irregularity

● this product generally produces bowel movement in 12 to 72 hours
Warnings

Do not use

● if you are presently taking mineral oil, unless told to do so by a doctor

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

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 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
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 ingredients

D&C red no. 33, FD&C blue no. 1, FD&C red no. 40, FD&C yellow no. 6, gelatin, glycerin, mannitol, pharmaceutical ink, polyethylene glycol 400, propylene glycol, sorbitan, sorbitol, titanium dioxide, water
Questions?

Call 1-866-844-2798 or visit www.Dulcolax.com
PRINCIPAL DISPLAY PANEL

Dulcolax
Pink
STOOL SOFTENER
25 SOFTGELS

INGREDIENTS AND APPEARANCE

DULCOLAX PINK STOOL SOFTENER
docusate sodium capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:41167-0281
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
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
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)
MANNITOL (UNII: 3OWL53L36A)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SORBITAN (UNII: 6O92ICV9RU)
SORBITOL (UNII: 506T60A25R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	RED, WHITE	Score	no score
Shape	OVAL	Size	13mm
Flavor		Imprint Code	L486
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:41167-0281-1	1 in 1 CARTON	02/18/2018
1		25 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC:41167-0281-2	1 in 1 CARTON	09/07/2018
2		30 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part334	02/18/2018

Labeler - Chattem, Inc. (003336013)

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Medic

DULCOLAX PINK STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [CHATTEM, INC.]

Ask a doctor before use if you have

Stop use and ask a doctor if

If pregnant or breast-feeding,

Keep out of reach of children.

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