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

Ask a doctor before use if you

• have stomach pain, nausea or vomiting

• have a sudden change in bowel habits that persists over a period of 2 weeks

• are presently taking mineral oil

Stop use and ask a doctor if

• you need to use a laxative longer than 1 week

• you have rectal bleeding or fail to have a bowel movement. These

could be signs of a serious condition.

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

• do not exceed recommended dose
• adults and children 12 years and older: take 1-3
softgels daily until first bowel movement; 1 softgel
daily thereafter, or as directed by a doctor
• children under 12: consult a doctor

Other information

• each softgel contains: sodium 7 mg. Very low sodium
• store at 59°-77°F (15°-25°C)
• keep tightly closed
• Tamper Evident: Do not use if imprinted seal
under cap is missing or broken.

Inactive ingredients

FD&C red #40, FD&C yellow #6 (sunset yellow), gelatin, glycerin, PEG, sorbitol special, water.

HOW SUPPLIED

NDC: 71335-0294-1: 30 Tablets in a BOTTLE

NDC: 71335-0294-2: 100 Tablets in a BOTTLE

NDC: 71335-0294-3: 60 Tablets in a BOTTLE

NDC: 71335-0294-4: 120 Tablets in a BOTTLE

NDC: 71335-0294-5: 90 Tablets in a BOTTLE

NDC: 71335-0294-6: 180 Tablets in a BOTTLE

NDC: 71335-0294-7: 10 Tablets in a BOTTLE

NDC: 71335-0294-8: 28 Tablets in a BOTTLE

NDC: 71335-0294-9: 56 Tablets in a BOTTLE

NDC: 71335-0294-0: 18 Tablets in a BOTTLE

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

Docusate Sodium 100mg Capsule

STOOL SOFTENER
docusate sodium capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71335-0294(NDC:57896-401)
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)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
MANNITOL (UNII: 3OWL53L36A)

Product Characteristics
Color	red (reddish)	Score	no score
Shape	OVAL	Size	12mm
Flavor		Imprint Code	SCU1
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:71335-0294-1	30 in 1 BOTTLE; Type 0: Not a Combination Product	04/11/2018
2	NDC:71335-0294-2	100 in 1 BOTTLE; Type 0: Not a Combination Product	02/27/2018
3	NDC:71335-0294-3	60 in 1 BOTTLE; Type 0: Not a Combination Product	05/23/2018
4	NDC:71335-0294-4	120 in 1 BOTTLE; Type 0: Not a Combination Product	02/09/2022
5	NDC:71335-0294-5	90 in 1 BOTTLE; Type 0: Not a Combination Product	05/23/2018
6	NDC:71335-0294-6	180 in 1 BOTTLE; Type 0: Not a Combination Product	02/09/2022
7	NDC:71335-0294-7	10 in 1 BOTTLE; Type 0: Not a Combination Product	02/09/2022
8	NDC:71335-0294-8	28 in 1 BOTTLE; Type 0: Not a Combination Product	09/20/2019
9	NDC:71335-0294-9	56 in 1 BOTTLE; Type 0: Not a Combination Product	02/09/2022
10	NDC:71335-0294-0	50 in 1 BOTTLE; Type 0: Not a Combination Product	05/18/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M007	01/01/2000

Labeler - Bryant Ranch Prepack (171714327)

Registrant - Bryant Ranch Prepack (171714327)

Name	Address	ID/FEI	Business Operations
Establishment
Bryant Ranch Prepack		171714327	REPACK(71335-0294) , RELABEL(71335-0294)

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