Stool Softener Regular Strength

Set ID
46be4007-399f-4e43-9330-ac36f2de96ef
Manufacturer
Spirit Pharmaceuticals LLC
Effective date
2024-12-10
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:41:56

Key Label Information

Active Ingredients And Purpose

Active Ingredient (in each tablet)

Docusate sodium 100 mg

Purpose

Stool softener

Uses

Uses

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

Warnings

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

• fever • mucus in the stool

Ask a doctor or pharmacist before use if you are if you have

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

Directions And Dosage

Directions

take only by mouth. Doses may be taken as asingle daily dose or in divided doses. adults & children 12 years of age & over take 1–3 softgels daily children 2 to under 12 years of age take 1 softgel daily children under 2 years of age ask a doctor

Other Label Information

Other information

• store at 25°C (77°F); excursions permitted between 15°–30°C (59°–86°F) • Keep tightly closed

Inactive ingredients

FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol-400, povidone, propylene glycol, purified water, sorbitol solution

Questions or comments?

1-888-333-9792

Pouch

Products

NDC Codes

Ingredients

NameUNIIKind
FD&C RED NO. 40WZB9127XOAIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
POVIDONEFZ989GH94EIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SORBITOL SOLUTION8KW3E207O2IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
DOCUSATE SODIUMF05Q2T2JA0ACTIB

Complete SPL Sections

Drug Facts

SPL UNCLASSIFIED SECTION

Active Ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Docusate sodium 100 mg

Purpose

OTC - PURPOSE SECTION

Stool softener

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

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

• fever • mucus in the stool

Ask a doctor or pharmacist before use if you are if you have

OTC - ASK DOCTOR/PHARMACIST SECTION

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

• you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition • you need to use a stool softener laxative for more than 1 week

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

DOSAGE & ADMINISTRATION SECTION

take only by mouth. Doses may be taken as asingle daily dose or in divided doses. adults & children 12 years of age & over take 1–3 softgels daily children 2 to under 12 years of age take 1 softgel daily children under 2 years of age ask a doctor

Other information

STORAGE AND HANDLING SECTION

• store at 25°C (77°F); excursions permitted between 15°–30°C (59°–86°F) • Keep tightly closed

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol-400, povidone, propylene glycol, purified water, sorbitol solution

Questions or comments?

OTC - QUESTIONS SECTION

1-888-333-9792

Distributed by:

SPL UNCLASSIFIED SECTION

Cabinet Health P.B.C.

Pouch

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Source Document

Official SPL XML cached by FDA.report · DailyMed PDF

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Legacy File Index

FolderFileDate
otc28f06503-2795-a3ce-e063-6394a90a93d2.xml2024-12-12
otc0bdfb32e-3ef7-af4d-e063-6394a90a03ab.xml2023-12-07
otcef1965cc-423f-2119-e053-2995a90a6241.xml2022-12-06
otcd168c189-5087-cc91-e053-2a95a90ac603.xml2021-11-23
otcStool Softener.jpg2021-11-23