STOOL SOFTENER- docusate sodium capsule, liquid filled 
Bryant Ranch Prepack

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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GC 401(408)

Active ingredient (in each softgel)

Docusate Sodium 100 mg

Purpose

Stool Softener Laxative

Uses

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

• adults and children 12 years and older: take 1-2 softgel daily until first bowel movement; 1 softgel daily thereafter, or as directed by doctor

• children under 12: consult a doctor

• do not exceed recommended dose

Other information

• each softgel contains: sodium 5 mg. very low sodium

• store at 15°C-25°C(59° F-77° F)

• keep tightly closed

• product from USA or Canada

• Tamper Evident: Do not use if imprinted seal under cap is missing or broken.

Inactive ingredients

FD&C red #40, gelatin, glycerin, edible ink, PEG, propylene glycol, sorbitol special, water. Also contains D&C yellow #10
or FD&C yellow #6 (sunset yellow).

HOW SUPPLIED

Product: 71335-1539

NDC: 71335-1539-0 18 CAPSULE, LIQUID FILLED in a BOTTLE

NDC: 71335-1539-1 30 CAPSULE, LIQUID FILLED in a BOTTLE

NDC: 71335-1539-2 100 CAPSULE, LIQUID FILLED in a BOTTLE

NDC: 71335-1539-3 60 CAPSULE, LIQUID FILLED in a BOTTLE

NDC: 71335-1539-4 120 CAPSULE, LIQUID FILLED in a BOTTLE

NDC: 71335-1539-5 90 CAPSULE, LIQUID FILLED in a BOTTLE

NDC: 71335-1539-6 180 CAPSULE, LIQUID FILLED in a BOTTLE

NDC: 71335-1539-7 10 CAPSULE, LIQUID FILLED in a BOTTLE

NDC: 71335-1539-8 28 CAPSULE, LIQUID FILLED in a BOTTLE

NDC: 71335-1539-9 56 CAPSULE, LIQUID FILLED in a BOTTLE

Docusate Sodium 100mg Capsule

Label Image
STOOL SOFTENER 
docusate sodium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71335-1539(NDC:57896-408)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM100 mg
Inactive Ingredients
Ingredient NameStrength
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SORBITOL (UNII: 506T60A25R)  
WATER (UNII: 059QF0KO0R)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
MANNITOL (UNII: 3OWL53L36A)  
Product Characteristics
ColorredScoreno score
ShapeOVALSize12mm
FlavorImprint Code A92
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71335-1539-2100 in 1 BOTTLE; Type 0: Not a Combination Product03/26/2020
2NDC:71335-1539-590 in 1 BOTTLE; Type 0: Not a Combination Product03/26/2020
3NDC:71335-1539-018 in 1 BOTTLE; Type 0: Not a Combination Product03/26/2020
4NDC:71335-1539-828 in 1 BOTTLE; Type 0: Not a Combination Product03/26/2020
5NDC:71335-1539-6180 in 1 BOTTLE; Type 0: Not a Combination Product03/26/2020
6NDC:71335-1539-360 in 1 BOTTLE; Type 0: Not a Combination Product03/26/2020
7NDC:71335-1539-956 in 1 BOTTLE; Type 0: Not a Combination Product03/26/2020
8NDC:71335-1539-4120 in 1 BOTTLE; Type 0: Not a Combination Product03/26/2020
9NDC:71335-1539-130 in 1 BOTTLE; Type 0: Not a Combination Product03/26/2020
10NDC:71335-1539-710 in 1 BOTTLE; Type 0: Not a Combination Product03/26/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33403/01/2018
Labeler - Bryant Ranch Prepack (171714327)
Establishment
NameAddressID/FEIBusiness Operations
Bryant Ranch Prepack171714327REPACK(71335-1539) , RELABEL(71335-1539)

Revised: 5/2020
Document Id: fc2f78aa-37a2-4658-86fe-187322902a30
Set id: b1d37f9e-ae8b-45c9-9c55-b094b2b0bce0
Version: 1
Effective Time: 20200522
 
Bryant Ranch Prepack