Colace

Manufacturer
ATLANTIS CONSUMER HEALTHCARE INC | Purdue Pharma LP | Contract Pharmacal Corporation | P&L Development, LLC | Patheon Softgels Inc.
Effective date
2023-12-22
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:16:40

Label at a glance#

ProductColace Kit
Active ingredientDOCUSATE SODIUM, SENNOSIDES
Label structure23 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Drug Facts

Active ingredients (in each tablet)

Docusate sodium 50 mg

Sennosides 8.6 mg

OTC - PURPOSE SECTION

Purpose

Stool softener

Stimulant laxative

INDICATIONS & USAGE SECTION

Uses

  • relieves occasional constipation (irregularity)
  • generally produces bowel movement in 6 to 12 hours

OTC - DO NOT USE SECTION

Warnings

Do not use

  • laxative products for longer than 1 week unless told todo so by a doctor
  • if you are presently taking mineral oil, unless told todo so by a doctor

OTC - ASK DOCTOR SECTION

Ask a doctor beforeuse if you have

  • stomach pain
  • nausea
  • vomiting
  • noticed a sudden change in bowel habits that lasts over2 weeks

OTC - STOP USE SECTION

Stop use andask a doctor if you have rectal bleeding or fail to have abowel movement after use of a laxative. These could be signs of aserious condition.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out ofreach of children. In case of overdose, get medical help orcontact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions

  • Take only by mouth. Doses may be taken as a single dailydose, preferably in the evening, or in divided doses
adults and children12 years and overtake 2-4 tabletsdaily
children 6 to under12 years of agetake 1-2 tabletsdaily
children 2 to under6 years of agetake up to 1 tabletdaily
children under2ask a doctor

HOW SUPPLIED SECTION

Other information

  • each tablet contains: calcium 7 mg, sodium 4 mg VERYLOW SODIUM
  • store at 25°C (77°F); excursions permitted between 15°-30°C(59°-86°F).

INACTIVE INGREDIENT SECTION

Inactive ingredients

Croscarmellose sodium,dicalcium phosphate, FD&C Blue #1 Lake, FD&C Red #40 Lake,FD&C Yellow #6 Lake, hypromellose, magnesium stearate, maltodextrin,microcrystalline cellulose, mineral oil, polyethylene glycol, sodiumbenzoate, sodium lauryl sulfate, starch, stearic acid, talc, titaniumdioxide, triacetin

©2020

Avrio HealthL.P.

305608-0A

OTC - ACTIVE INGREDIENT SECTION

Colace

Drug Facts

Active ingredient (in eachcapsule)

Docusate sodium 100 mg

OTC - PURPOSE SECTION

Purpose:

Stool softener

INDICATIONS & USAGE SECTION

Uses

  • relieves occasional constipation (irregularity)
  • generally produces bowel movement in 12 to 72 hours

OTC - DO NOT USE SECTION

Warnings

Do not use

  • if you are presently taking mineral oil, unless told todo so by a doctor

OTC - ASK DOCTOR SECTION

Ask a doctor beforeuse if you have

  • stomach pain
  • nausea
  • vomiting
  • noticed a sudden change in bowel habits that lasts over2 weeks

OTC - STOP USE SECTION

Stop use andask a doctor if

  • you have rectal bleeding or fail to have a bowel movementafter use of a laxative. These could be signs of a serious condition
  • you need to use a stool softener laxative for more than1 week

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reachof children. In case of overdose, get medical help or contacta Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions: Take only by mouth. Doses may be taken as a single dailydose or in divided doses.

adults and children12 years and overtake 1-3 capsulesdaily
children 2 to under12 years of agetake 1 capsuledaily
children under2 yearsask a doctor

HOW SUPPLIED SECTION

Other information

  • each capsule contains: sodium 5 mg VERY LOW SODIUM
  • store at 25°C (77°F); excursions permitted between 15°-30°C(59°-86°F).

Keep tightly closed.

INACTIVE INGREDIENT SECTION

Inactive ingredients

D&C Red No. 33, FD&C Blue #1, FD&C Red No. 40,
FD&C Yellow No. 6, gelatin, glycerin, PEG
400, propylene glycol, sorbitol, titanium
dioxide

©2018,

Avrio Health L.P.

304996-0A

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Colance KitColance Kit

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67618-110-10EA - Each67618-11097f64826-6da0-4225-8a8c-fd5c79f1d29012017-06-15
67618-110-30EA - Each67618-110cc0b7afb-4dbc-4de0-9baf-f0a11bf2e3c212017-06-15
67618-110-60EA - Each67618-1108ed23b60-d6db-4138-9d8d-ba01cc4db8ec12017-06-15
67618-101-01EA - Each67618-101f2ec6fdd-0022-4ae9-9cb1-1283a1d2759b12022-03-09
67618-101-10EA - Each67618-101676d3b90-74ba-48c7-af2d-57967b4b589012013-02-13
67618-101-30EA - Each67618-10131b331a1-c148-43af-8b5b-a8c2e1bca3e012012-07-24
67618-101-52EA - Each67618-101fa2dae37-1524-44fa-88c8-abc6ffaa91f112012-07-24
67618-101-60EA - Each67618-101019c7bf6-c568-44be-8113-3fe6d46ce30512012-07-24

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67618-11067618-110-30
67618-10167618-101-60
67618-37267618-372-60

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 31 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ColaceDOCUSATE SODIUMAtlantis Consumer Healthcare, Inc.7793fced-e8ee-44e2-b212-dd2a59a5f4622026-08-04WarningsExact identifier
ndc (package): 67618-101-60
ndc (product): 67618-101
ndc11 (package): 67618010160
1a28ceb0-db46-48e1-916c-578e8d82298ac5c61aa9-1fb2-96d9-f80f-cd6b44f2b2f62023-12-22Exact identifier
spl id: 1a28ceb0-db46-48e1-916c-578e8d82298a
spl set id: c5c61aa9-1fb2-96d9-f80f-cd6b44f2b2f6

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.