Docusate

Docusate
SPL v2
SPL
SPL Set ID 68165491-0e0c-52d9-e053-2a91aa0ae5f1
Route
ORAL
Published
Effective Date 2018-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Docusate (100 mg)
Inactive Ingredients
Sorbitol Fd&c Red No. 40 Gelatin Glycerin Propylene Glycol Food Yellow 3 Free Acid Sorbitan Polyethylene Glycols Water Medium-chain Triglycerides

Identifiers & Packaging

Pill Appearance
Imprint: P51;S77;SCU1 Shape: oval Color: orange Size: 12 mm Score: 1
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2018-01-01

Description

Docusate Sodium 100 mg

Purpose

Stool softener laxative


Medication Information

Purpose

Stool softener laxative

Description

Docusate Sodium 100 mg

Uses

relieves occasional constipation (irregularity)

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

vomiting

noticed a sudden change in bowel habits that last over 2 weeks

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 a 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 only by mouth. Doses may be taken as a single daily dose or in divided doses.

adults and children 12 years and over take 1 to 3 softgels daily.

children 2 to under 12 years of age take 1 softgel daily

children under 2 years ask a doctor

Other Information

each softgel contains: sodium 6 mg

store at 25ºC (77ºF);excursions permitted between 15-30ºC (59-86ºF)

Inactive Ingredients

edible ink, FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol*, purified water sorbitan, sorbitol

*contains one or more of these ingredients

Questions Or Comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Keep Out of Reach of Children

Keep out of reach of children.

Active Ingredient (in Each Softgel)

Docusate Sodium 100 mg


Structured Label Content

Uses (USES)

relieves occasional constipation (irregularity)

generally produces bowel movement in 12 to 72 hours

Purpose (PURPOSE)

Stool softener laxative

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

stomach pain

nausea

vomiting

noticed a sudden change in bowel habits that last over 2 weeks

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 a 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 (DIRECTIONS)

take only by mouth. Doses may be taken as a single daily dose or in divided doses.

adults and children 12 years and over take 1 to 3 softgels daily.

children 2 to under 12 years of age take 1 softgel daily

children under 2 years ask a doctor

Other Information (OTHER INFORMATION)

each softgel contains: sodium 6 mg

store at 25ºC (77ºF);excursions permitted between 15-30ºC (59-86ºF)

Inactive Ingredients (INACTIVE INGREDIENTS)

edible ink, FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol*, purified water sorbitan, sorbitol

*contains one or more of these ingredients

Questions Or Comments? (QUESTIONS OR COMMENTS?)

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

Keep out of reach of children.

Active Ingredient (in Each Softgel) (ACTIVE INGREDIENT (IN EACH SOFTGEL))

Docusate Sodium 100 mg


Advanced Ingredient Data


Raw Label Data

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