Dulcolax Pink Stool Softener: Package Insert and Label Information

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

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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 ingredient s

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

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 DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM 100 mg

Inactive Ingredients Ingredient Name Strength D&C RED NO. 33 FD&C BLUE NO. 1 FD&C RED NO. 40 FD&C YELLOW NO. 6 GELATIN GLYCERIN MANNITOL POLYETHYLENE GLYCOL 400 PROPYLENE GLYCOL SORBITAN SORBITOL TITANIUM DIOXIDE WATER

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

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:41167-0281-1 1 BOTTLE in 1 CARTON contains a BOTTLE 1 25 CAPSULE, LIQUID FILLED in 1 BOTTLE This package is contained within the CARTON (41167-0281-1) 2 NDC:41167-0281-2 1 BOTTLE in 1 CARTON contains a BOTTLE 2 30 CAPSULE, LIQUID FILLED in 1 BOTTLE This package is contained within the CARTON (41167-0281-2)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 02/18/2018

Labeler — Chattem, Inc. (003336013)

Revised: 10/2022 Chattem, Inc.