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

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.

Uses

• relieves occasional constipation (irregularity)

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

Purpose

Stool softener laxative

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

Description

Docusate Sodium 100 mg

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.

Packaging

Drug Facts

Questions Or Comments?

1(888) 577-8033

Active Ingredient (in Each Softgel)

Docusate Sodium 100 mg

Structured Label Content

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.

Uses

• relieves occasional constipation (irregularity)

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

Purpose

Stool softener laxative

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 (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

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.

Packaging

Drug Facts

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

[{"name": "DOCUSATE", "unii": "M7P27195AG", "classCode": "ACTIB", "strengthNumerator": "100", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "FD&C RED NO. 40", "unii": "WZB9127XOA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C YELLOW NO. 6", "unii": "H77VEI93A8", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GELATIN, UNSPECIFIED", "unii": "2G86QN327L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL 400", "unii": "B697894SGQ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITAN", "unii": "6O92ICV9RU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

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