Active ingredient (in each softgel)

Docusate Sodium 100 mg

Purpose

Stool softener laxative

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

stomach pain
nausea
vomiting
noticed a sudden change in bowel habits that lasts over 2 weeks

Stop use and ask a doctor if

you have rectal bleeding or fail to have a bowel movement after using a laxative. These could be a sign of a serious condition.
you need to use a stool softener laxative for more than 1 week

If pregnant or breast-feeding,

ask a health care professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center (1-800-2222-1222) 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 1-3 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 7 mg
store at 25ºC (77ºF); excursion permitted between 15-30ºC (59-86ºF)

Inactive ingredients

citric acid, FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water sorbitol special, white edible ink

Questions or comments?

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

HOW SUPPLIED

Docusate Sodium 100 mg

NDC: 71335-9731-1: 30 Tablets in a BOTTLE

NDC: 71335-9731-2: 100 Tablets in a BOTTLE

NDC: 71335-9731-3: 60 Tablets in a BOTTLE

NDC: 71335-9731-4: 120 Tablets in a BOTTLE

NDC: 71335-9731-5: 90 Tablets in a BOTTLE

NDC: 71335-9731-6: 180 Tablets in a BOTTLE

NDC: 71335-9731-7: 10 Tablets in a BOTTLE

NDC: 71335-9731-8: 28 Tablets in a BOTTLE

NDC: 71335-9731-9: 56 Tablets in a BOTTLE

NDC: 71335-9731-0: 18 Tablets in a BOTTLE

Repackaged/Relabeled by:
Bryant Ranch Prepack, Inc.
Burbank, CA 91504

Docusate Sodium 100 mg Capsule

STOOL SOFTENER LAXATIVE
docusate sodium capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71335-9731(NDC:0904-7280)
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)	DOCUSATE SODIUM	100 mg

Ingredient Name	Strength
Inactive Ingredients
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
GLYCERIN (UNII: PDC6A3C0OX)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SORBITAN (UNII: 6O92ICV9RU)

Product Characteristics
Color	red	Score	no score
Shape	CAPSULE (Oval)	Size	13mm
Flavor		Imprint Code	PC1
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:71335-9731-1	30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/18/2023
2	NDC:71335-9731-2	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/09/2023
3	NDC:71335-9731-3	60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/17/2023
4	NDC:71335-9731-4	120 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/30/2024
5	NDC:71335-9731-5	90 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/17/2023
6	NDC:71335-9731-6	180 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/30/2024
7	NDC:71335-9731-7	10 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/30/2024
8	NDC:71335-9731-8	28 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/30/2024
9	NDC:71335-9731-9	56 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/30/2024
10	NDC:71335-9731-0	18 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/30/2024

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M007	11/15/2022

Labeler - Bryant Ranch Prepack (171714327)

Registrant - Bryant Ranch Prepack (171714327)

Name	Address	ID/FEI	Business Operations
Establishment
Bryant Ranch Prepack		171714327	REPACK(71335-9731) , RELABEL(71335-9731)

DRUG FACTS