Peri-Colace

Manufacturer: Purdue Products LP | Purdue Pharma LP | Purdue Pharma
Effective date: 2013-09-16
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: legacy-cache
Hydrated at: 2026-08-02 01:39:47

Label at a glance#

ProductPeri-Colace

Active ingredientDOCUSATE SODIUM, SENNOSIDES

Label structure11 sections

Indications and uses

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

Label contents#

Full prescribing information#

Active ingredients (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Docusate sodium 50 mg

Sennosides 8.6 mg

Purpose

OTC - PURPOSE SECTION

Stool softener

Stimulant laxative

Uses

OTC - WHEN USING SECTION

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

Do not use

OTC - DO NOT USE SECTION

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

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

stomach pain
nausea
vomiting
noticed a sudden change in bowel habits that lasts over 2 weeks

OTC - ASK DOCTOR/PHARMACIST SECTION

Stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition.

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

Directions

Take only by mouth. Doses may be taken as a single daily dose, preferably in the evening, or in divided doses

adults and children 12 years and over	take 2-4 tablets daily
children 6 to under 12 years of age	take 1-2 tablets daily
children 2 to under 6 years of age	take up to 1 tablet daily
children under 2	ask a doctor

Other information

HOW SUPPLIED SECTION

each tablet contains: calcium 10 mg, sodium 4 mg VERY LOW SODIUM
store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F).

Keep tightly closed.

Inactive ingredients

INACTIVE INGREDIENT SECTION

dicalcium phosphate, FD&C Red #40 Aluminum Lake, FD&C Blue #2 Aluminum Lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, sodium benzoate, talc, and titanium dioxide

Mfd. for: Purdue Products L.P.
Stamford, CT 06901-3431

By: Purdue Pharma, 575 Granite Court
Pickering, ON L1W 3W8, Canada
303048-0A

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Peri-Colace^® Tablets
NDC: 67618-106-30

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
67618-106-04	2023-09-26	C162847	48780-1	9855d018-ef0c-cd31-e053-dbdaa90ab51a	Peri-Colace Drug Facts
67618-106-10	2023-09-26	C162847	48780-1	9855d018-ef0c-cd31-e053-dbdaa90ab51a	Peri-Colace Drug Facts
67618-106-30	2023-09-26	C162847	48780-1	9855d018-ef0c-cd31-e053-dbdaa90ab51a	Peri-Colace Drug Facts
67618-106-60	2023-09-26	C162847	48780-1	9855d018-ef0c-cd31-e053-dbdaa90ab51a	Peri-Colace Drug Facts
67618-106-04	2019-11-27	C162847	48780-1	9855d018-ef0c-cd31-e053-dbdaa90ab51a	Peri-Colace Drug Facts
67618-106-10	2019-11-27	C162847	48780-1	9855d018-ef0c-cd31-e053-dbdaa90ab51a	Peri-Colace Drug Facts
67618-106-30	2019-11-27	C162847	48780-1	9855d018-ef0c-cd31-e053-dbdaa90ab51a	Peri-Colace Drug Facts
67618-106-60	2019-11-27	C162847	48780-1	9855d018-ef0c-cd31-e053-dbdaa90ab51a	Peri-Colace Drug Facts

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
67618-106-10	EA - Each	67618-106	564f1d02-5a06-4ff7-9e53-cff105bd1a70	1	2013-10-17
67618-106-30	EA - Each	67618-106	5e5fe2e4-3527-4989-adb8-89f48a8d044e	1	2013-10-17
67618-106-60	EA - Each	67618-106	aecdc5e3-c94a-4330-a0c9-84d729e9263a	1	2013-10-17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
DOCUSATE SODIUM	ACTIVE INGREDIENT	F05Q2T2JA0	1
SENNOSIDES	ACTIVE INGREDIENT	3FYP5M0IJX	1
DOCUSATE	ACTIVE MOIETY	M7P27195AG	1
SENNOSIDES	ACTIVE MOIETY	3FYP5M0IJX	1
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	INACTIVE INGREDIENT	L11K75P92J	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	1
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	1
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	1

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

Peri-Colace
Docusate sodium - sennosides
DOCUSATE SODIUM
DOCUSATE
SENNOSIDES
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS
FD&C RED NO. 40
FD&C BLUE NO. 2
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOLS
POLYVINYL ALCOHOL
STARCH, CORN
SODIUM BENZOATE
TALC
TITANIUM DIOXIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
67618-106	67618-106-04, 67618-106-10, 67618-106-30, 67618-106-60

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
DOCUSATE SODIUM	F05Q2T2JA0	ACTIB
SENNOSIDES	3FYP5M0IJX	ACTIB
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	L11K75P92J	IACT
FD&C RED NO. 40	WZB9127XOA	IACT
FD&C BLUE NO. 2	L06K8R7DQK	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
POLYETHYLENE GLYCOLS	3WJQ0SDW1A	IACT
POLYVINYL ALCOHOL	532B59J990	IACT
STARCH, CORN	O8232NY3SJ	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT
TALC	7SEV7J4R1U	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 5 · 270 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET, COATED / ORAL		256 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET, EXTENDED RELEASE / ORAL		184 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	TABLET, COATED / ORAL	0.2 mg		Exact identifier — unii candidate 35 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	IMPLANT / SUBCUTANEOUS	0.5 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	POWDER, FOR SUSPENSION / ORAL		4441 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
FD&C BLUE NO. 2	FD&C BLUE NO. 2	L06K8R7DQK	CAPSULE, DELAYED RELEASE / ORAL	0.22 mg		Exact identifier — unii candidate 11 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 28 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE / ORAL		72 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	SOAP / TOPICAL	1 %w/w		Exact identifier — unii candidate 40 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	TABLET, EXTENDED RELEASE / ORAL	2.22 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 40 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	GEL / TOPICAL		5 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	SYRUP / ORAL		80 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, COATED PELLETS / ORAL	NA		Exact identifier — unii candidate 28 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	SOLUTION / DENTAL	NA		Exact identifier — unii candidate 28 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, COATED / ORAL	320.75 mg		Exact identifier — unii candidate 35 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	GRANULE / ORAL		322 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	GUM, CHEWING / BUCCAL	NA		Exact identifier — unii candidate 35 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	PASTE, DENTIFRICE / DENTAL	0.4 %w/w		Exact identifier — unii candidate 40 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	LOZENGE / ORAL		50 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	ANHYDROUS DIBASIC CALCIUM PHOSPHATE	L11K75P92J	TABLET, DELAYED RELEASE / ORAL		2834 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	SUSPENSION / ORAL		113 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	ELIXIR / ORAL	4.5 mg/5ml		Exact identifier — unii candidate 35 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	SUSPENSION / ORAL		900 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	PELLET / ORAL		69 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	POWDER, FOR SUSPENSION / ORAL		120 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	SYSTEM / TOPICAL		2 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	GRANULE / ORAL		29520 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET, ORALLY DISINTEGRATING / ORAL		100 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	IMPLANT / INTRAVITREAL	NA		Exact identifier — unii candidate 39 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	SUSPENSION/ DROPS / ORAL		1 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
POLYVINYL ALCOHOL	POLYVINYL ALCOHOL	532B59J990	AEROSOL, FOAM / VAGINAL	0.5 %w/w		Exact identifier — unii candidate 17 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	FILM, EXTENDED RELEASE / TRANSDERMAL	NA		Exact identifier — unii candidate 40 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	DROPS / ORAL	NA		Exact identifier — unii candidate 35 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	CAPSULE / ORAL		729 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	CAPSULE, COATED / ORAL		87 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	SUSPENSION, EXTENDED RELEASE / ORAL		71 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	SYSTEM / TOPICAL		420 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	CAPSULE, EXTENDED RELEASE / ORAL		5119 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	OINTMENT / TOPICAL	5 %w/w		Exact identifier — unii candidate 40 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, LIQUID FILLED / ORAL		1 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	ANHYDROUS DIBASIC CALCIUM PHOSPHATE	L11K75P92J	TABLET / SUBLINGUAL		28 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	POWDER / ORAL	2 mg		Exact identifier — unii candidate 40 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, DELAYED RELEASE / ORAL		55 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, ORALLY DISINTEGRATING / ORAL		6 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	SHAMPOO / TOPICAL		2 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		9 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, CHEWABLE / ORAL		1725 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, DELAYED RELEASE / ORAL		349 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, EXTENDED RELEASE / ORAL		173 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	SUSPENSION / ORAL		1600 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	INJECTION / INTRAVENOUS		864 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / BUCCAL	17.5 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, DELAYED RELEASE / ORAL		2210 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, COATED / ORAL	NA		Exact identifier — unii candidate 28 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	CAPSULE / ORAL	256.4 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
POLYVINYL ALCOHOL	POLYVINYL ALCOHOL	532B59J990	IMPLANT / INTRAVITREAL	0.12 mg		Exact identifier — unii candidate 17 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, FOR SUSPENSION / ORAL		131 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, DELAYED RELEASE / ORAL		2 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	GRANULE, DELAYED RELEASE / ORAL	789.6 mg		Exact identifier — unii candidate 28 equally ranked IID candidates

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
375b3695-7508-b765-6285-8acdf90b6929			f63ecf22-fb2b-8677-5bfe-c6ac368977a3	2023-09-04	Warnings	Exact identifier spl set id: f63ecf22-fb2b-8677-5bfe-c6ac368977a3

Reported adverse events (FAERS/openFDA)#

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