DULCOLAX STOOL SOFTENER- docusate sodium capsule, liquid filled 
Chattem, Inc.

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Dulcolax Stool Softener - Patheon

Dulcolax®

Stool Softener Carton

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

● contains FD&C Yellow No. 6

● do not use this product if the safety seal under the cap is torn or missing

Inactive ingredients

FD&C red no. 40, FD&C yellow no. 6, gelatin, glycerin, mannitol, pharmaceutical ink, polyethylene glycol 400, propylene glycol, sorbitan, sorbitol, water

Questions?

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

Keep carton as it contains important product information.

PRINCIPAL DISPLAY PANEL

Dulcolax

Stool Softener

25 Liquid Gels

Dulcolax
Stool Softener 
25 Liquid Gels

DULCOLAX STOOL SOFTENER 
docusate sodium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-0221
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM100 mg
Inactive Ingredients
Ingredient NameStrength
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)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorredScoreno score
ShapeOVALSize10mm
FlavorImprint Code Dulcolax
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41167-0221-41 in 1 CARTON08/01/2020
1100 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:41167-0221-21 in 1 CARTON08/01/2020
225 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:41167-0221-31 in 1 CARTON08/01/2020
350 in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:41167-0221-91 in 1 CARTON08/01/2020
430 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph Drug505G(a)(3)08/01/2020
Labeler - Chattem, Inc. (003336013)

Revised: 11/2023
Document Id: 5dfcb760-8f43-4d3d-b34e-d814ab5ee28b
Set id: 86cb7102-3585-4757-9c37-5bf9776bbe63
Version: 2
Effective Time: 20231103
 
Chattem, Inc.