Major®

Drug Facts

Composition & Product

Active Ingredients

Docusate (100 mg)

Inactive Ingredients

Fd&c Red No. 40 Fd&c Yellow No. 6 Gelatin, Unspecified Glycerin Polyethylene Glycol 400 Propylene Glycol Water Sorbitol Sorbitan

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2025-11-25

Medication Information

Purpose

Stool softener laxative

Description

Docusate Sodium 100 mg

Uses

• relieves occasional constipation (irregularity)

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

Section 42229-5

NDC 0904-7609-61

MAJOR^® docusate sodium

docusate sodium 100 mg

stool softener

laxative

• stimulant-free

• relief of occasional constipation

100 softgels

(10x10) unit dose

Distributed by:

MAJOR^® PHARMACEUTICALS

Indianapolis, IN 46268

(800) 616-2471

www.major-rugby.com

Made in India

CT0904760961

REV.00-092025

Rev. 10/25 M-173 Re-order No. 701455

READ AND KEEP OUTER CARTON FOR COMPLETE

PRODUCT WARNINGS AND INFORMATION

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER

UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

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

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

• 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.

Packaging

Directions

• take only by mouth • 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

Drug Facts

Other Information

• each softgel contains: sodium 5 mg (very low sodium)

• store at controlled room temperature 20–25°C (68–77°F)

• protect from light, heat and moisture

Inactive Ingredients

FD&C Red No.40, FD&C Yellow No.6, gelatin, glycerin, polyethylene glycol 400, propylene glycol, purified water, sorbitol sorbitan solution

Questions Or Comments?

1(888) 577-8033

Active Ingredient (in Each Softgel)

Docusate Sodium 100 mg

Structured Label Content

Uses

• relieves occasional constipation (irregularity)

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

Section 42229-5 (42229-5)

NDC 0904-7609-61

MAJOR^® docusate sodium

docusate sodium 100 mg

stool softener

laxative

• stimulant-free

• relief of occasional constipation

100 softgels

(10x10) unit dose

Distributed by:

MAJOR^® PHARMACEUTICALS

Indianapolis, IN 46268

(800) 616-2471

www.major-rugby.com

Made in India

CT0904760961

REV.00-092025

Rev. 10/25 M-173 Re-order No. 701455

READ AND KEEP OUTER CARTON FOR COMPLETE

PRODUCT WARNINGS AND INFORMATION

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER

UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

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

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

• 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.

Packaging

Directions

• take only by mouth • 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

Drug Facts

Other Information (Other information)

• each softgel contains: sodium 5 mg (very low sodium)

• store at controlled room temperature 20–25°C (68–77°F)

• protect from light, heat and moisture

Inactive Ingredients (Inactive ingredients)

FD&C Red No.40, FD&C Yellow No.6, gelatin, glycerin, polyethylene glycol 400, propylene glycol, purified water, sorbitol sorbitan solution

Questions Or Comments? (Questions or comments?)

1(888) 577-8033

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": "• relieves occasional constipation (irregularity) • this product generally produces a bowel movement within 12 to 72 hours.", "42229-5": "NDC 0904-7609-61 MAJOR ® docusate sodium docusate sodium 100 mg stool softener laxative • stimulant-free • relief of occasional constipation 100 softgels (10x10) unit dose Distributed by: MAJOR ® PHARMACEUTICALS Indianapolis, IN 46268 (800) 616-2471 www.major-rugby.com Made in India CT0904760961 REV.00-092025 Rev. 10/25 M-173 Re-order No. 701455 READ AND KEEP OUTER CARTON FOR COMPLETE PRODUCT WARNINGS AND INFORMATION TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.", "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": "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 • 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 only by mouth • 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 5 mg (very low sodium) • store at controlled room temperature 20–25°C (68–77°F) • protect from light, heat and moisture", "Inactive ingredients": "FD&C Red No.40, FD&C Yellow No.6, gelatin, glycerin, polyethylene glycol 400, propylene glycol, purified water, sorbitol sorbitan solution", "Questions or comments?": "1(888) 577-8033", "Active ingredient (in each softgel)": "Docusate Sodium 100 mg"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information