Package Label

Package Label
SPL v4
SPL
SPL Set ID b8ce1cdd-2c22-1cbd-e053-2a95a90ae05d
Route
ORAL
Published
Effective Date 2013-04-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Identifiers & Packaging


Description

Docusate Sodium 100 mg


Medication Information

Warnings and Precautions

Ask a doctor before use if you • have stomach pain, nausea or vomiting • have a sudden change in bowel habits that persists over a period of 2 weeks • are presently taking mineral oil Stop use and ask a doctor if • you need to use a laxative longer than 1 week • you have rectal bleeding or fail to have a bowel movement. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use.

Indications and Usage

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

Dosage and Administration

do not exceed recommended dose Doses may be taken as a single daily dose or in divided doses. Adults and children 12 years and over take 1-3 softgels daily Children 6 to under 12 years of age take 1 softgel daily Children under 6 ask a doctor

Description

Docusate Sodium 100 mg

Section 44425-7

• each softgel contains: sodium 7 mg. Very low sodium • store at 59°-77°F (15°-25°C) • keep tightly closed • Tamper Evident: Do not use if imprinted seal under cap is missing or broken.

Section 50565-1

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

Section 51727-6

FD & C red #40, FD & C yellow #6 (sunset yellow), gelatin, glycerin, PEG, sorbitol special, water.

Section 51945-4

1

Section 55105-1

Stool Softener Laxative

Section 55106-9

Docusate Sodium 100 mg


Structured Label Content

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)

do not exceed recommended dose Doses may be taken as a single daily dose or in divided doses. Adults and children 12 years and over take 1-3 softgels daily Children 6 to under 12 years of age take 1 softgel daily Children under 6 ask a doctor

Warnings and Precautions (34071-1)

Ask a doctor before use if you • have stomach pain, nausea or vomiting • have a sudden change in bowel habits that persists over a period of 2 weeks • are presently taking mineral oil Stop use and ask a doctor if • you need to use a laxative longer than 1 week • you have rectal bleeding or fail to have a bowel movement. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use.

Section 44425-7 (44425-7)

• each softgel contains: sodium 7 mg. Very low sodium • store at 59°-77°F (15°-25°C) • keep tightly closed • Tamper Evident: Do not use if imprinted seal under cap is missing or broken.

Section 50565-1 (50565-1)

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

Section 51727-6 (51727-6)

FD & C red #40, FD & C yellow #6 (sunset yellow), gelatin, glycerin, PEG, sorbitol special, water.

Section 51945-4 (51945-4)

1

Section 55105-1 (55105-1)

Stool Softener Laxative

Section 55106-9 (55106-9)

Docusate Sodium 100 mg


Raw Label Data

All Sections (JSON)