Docusate Sodium - Stool Softener Laxative

Drug Facts

Composition & Product

Active Ingredients

Docusate (100 mg)

Inactive Ingredients

Fd&c Red No. 40 Fd&c Yellow No. 6 Gelatin, Unspecified Glycerin Isopropyl Alcohol Light Mineral Oil Medium-chain Triglycerides Polyethylene Glycol, Unspecified Propylene Glycol Water Sorbitol Sorbitan

Identifiers & Packaging

Pill Appearance

Imprint: 777 Shape: oval Color: red Size: 12 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2021-09-04

Medication Information

Purpose

Stool softener laxative

Description

Docusate Sodium 100 mg

Uses

• for relief of occasional constipation (irregularity)

• This generally produces a bowel movement within 12 to 72 hours.

Section 42229-5

MAJOR^®

Unit Dose

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

READ AND KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

Distributed by:

MAJOR^® PHARMACEUTICALS

Indianapolis, IN 46268

Distributed By:

Cardinal Health

Dublin, OH 43017

L57466800124

Product of UAE

Packaged and Quality Assured in the USA

CT0904718361

REV.01-032022

Section 50565-1

Keep out of reach of children

Overdose Warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

Warnings

Ask a doctor before use if you have

• abdominal pain, nausea, or vomiting

• a sudden change in bowel habits that lasts over 14 days

Ask a doctor or pharmacist before use if you are presently taking mineral oil

Stop use and ask a doctor if

• you have rectal bleeding or no bowel movement after using this product.

These can be signs of a serious condition

• you need to use a laxative for more than 1 week

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

Directions

• take softgels with a full glass (8 oz) of water

adults and children 12 years of age and older	take 1 to 3 softgels daily or as directed by a doctor. This dose may be taken as a single daily dose or in divided doses.
children 6 to under 12 years of age	take 1 softgel daily or as directed by a doctor
children under 6 years of age	ask a doctor

Other Information

• each softgel contains: sodium 10 mg (very low sodium)

• store at 25°C (77°F) in a dry place. Avoid excessive heat 40°C (140°F).

Overbagged with 10 liquid-filled capsules per bag, NDC 55154-3369-0

WARNING: This Unit Dose package is not child resistant and is Intended for Institutional Use Only. Keep this and all drugs out of the reach of children.

Inactive Ingredients

edible white ink, FD&C red no. 40, FD&C yellow no. 6, gelatin, glycerin, isopropyl alcohol, light mineral oil, medium chain triglycerides, polyethylene glycol, propylene glycol, purified water, sorbitol sorbitan solution

Principal Display Panel

NDC 55154-3369-0

DOCUSATE SODIUM 100 mg

Stool Softener Laxative

10 SOFTGELS

Questions Or Comments?

(800)616-2471

Active Ingredient (in Each Softgel)

Docusate Sodium 100 mg

Structured Label Content

Uses

• for relief of occasional constipation (irregularity)

• This generally produces a bowel movement within 12 to 72 hours.

Section 42229-5 (42229-5)

MAJOR^®

Unit Dose

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

READ AND KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

Distributed by:

MAJOR^® PHARMACEUTICALS

Indianapolis, IN 46268

Distributed By:

Cardinal Health

Dublin, OH 43017

L57466800124

Product of UAE

Packaged and Quality Assured in the USA

CT0904718361

REV.01-032022

Section 50565-1 (50565-1)

Keep out of reach of children

Overdose Warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

Purpose

Stool softener laxative

Warnings

Ask a doctor before use if you have

• abdominal pain, nausea, or vomiting

• a sudden change in bowel habits that lasts over 14 days

Ask a doctor or pharmacist before use if you are presently taking mineral oil

Stop use and ask a doctor if

• you have rectal bleeding or no bowel movement after using this product.

These can be signs of a serious condition

• you need to use a laxative for more than 1 week

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

Directions

• take softgels with a full glass (8 oz) of water

adults and children 12 years of age and older	take 1 to 3 softgels daily or as directed by a doctor. This dose may be taken as a single daily dose or in divided doses.
children 6 to under 12 years of age	take 1 softgel daily or as directed by a doctor
children under 6 years of age	ask a doctor

Other Information (Other information)

• each softgel contains: sodium 10 mg (very low sodium)

• store at 25°C (77°F) in a dry place. Avoid excessive heat 40°C (140°F).

Overbagged with 10 liquid-filled capsules per bag, NDC 55154-3369-0

WARNING: This Unit Dose package is not child resistant and is Intended for Institutional Use Only. Keep this and all drugs out of the reach of children.

Inactive Ingredients (Inactive ingredients)

edible white ink, FD&C red no. 40, FD&C yellow no. 6, gelatin, glycerin, isopropyl alcohol, light mineral oil, medium chain triglycerides, polyethylene glycol, propylene glycol, purified water, sorbitol sorbitan solution

Principal Display Panel

NDC 55154-3369-0

DOCUSATE SODIUM 100 mg

Stool Softener Laxative

10 SOFTGELS

Questions Or Comments? (Questions or comments? )

(800)616-2471

Active Ingredient (in Each Softgel) (Active ingredient (in each softgel))

Docusate Sodium 100 mg

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "• for relief of occasional constipation (irregularity) • This generally produces a bowel movement within 12 to 72 hours.", "42229-5": "MAJOR ® Unit Dose TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING READ AND KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION Distributed by: MAJOR ® PHARMACEUTICALS Indianapolis, IN 46268 Distributed By: Cardinal Health Dublin, OH 43017 L57466800124 Product of UAE Packaged and Quality Assured in the USA CT0904718361 REV.01-032022", "50565-1": "Keep out of reach of children Overdose Warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.", "Purpose": "Stool softener laxative", "Warnings": "Ask a doctor before use if you have • abdominal pain, nausea, or vomiting • a sudden change in bowel habits that lasts over 14 days Ask a doctor or pharmacist before use if you are presently taking mineral oil Stop use and ask a doctor if • you have rectal bleeding or no bowel movement after using this product. These can be signs of a serious condition • you need to use a laxative for more than 1 week If pregnant or breast-feeding , ask a health care professional before use.", "Directions": "• take softgels with a full glass (8 oz) of water adults and children 12 years of age and older take 1 to 3 softgels daily or as directed by a doctor. This dose may be taken as a single daily dose or in divided doses. children 6 to under 12 years of age take 1 softgel daily or as directed by a doctor children under 6 years of age ask a doctor", "Other information": "• each softgel contains: sodium 10 mg (very low sodium) • store at 25°C (77°F) in a dry place. Avoid excessive heat 40°C (140°F). Overbagged with 10 liquid-filled capsules per bag, NDC 55154-3369-0 WARNING: This Unit Dose package is not child resistant and is Intended for Institutional Use Only. Keep this and all drugs out of the reach of children.", "Inactive ingredients": "edible white ink, FD&C red no. 40, FD&C yellow no. 6, gelatin, glycerin, isopropyl alcohol, light mineral oil, medium chain triglycerides, polyethylene glycol, propylene glycol, purified water, sorbitol sorbitan solution", "Principal Display Panel": "NDC 55154-3369-0 DOCUSATE SODIUM 100 mg Stool Softener Laxative 10 SOFTGELS", "Questions or comments? ": "(800)616-2471 ", "Active ingredient (in each softgel)": "Docusate Sodium 100 mg"}

Docusate Sodium - Stool Softener Laxative

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information