Label: STOOL SOFTENER- docusate sodium capsule, liquid filled

  • NDC Code(s): 71335-1539-0, 71335-1539-1, 71335-1539-2, 71335-1539-3, view more
    71335-1539-4, 71335-1539-5, 71335-1539-6, 71335-1539-7, 71335-1539-8, 71335-1539-9
  • Packager: Bryant Ranch Prepack
  • This is a repackaged label.
  • Source NDC Code(s): 57896-408
  • Category: HUMAN OTC DRUG LABEL

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.

Drug Label Information

Updated May 22, 2020

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  • 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

    • 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
  • INGREDIENTS AND APPEARANCE
    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)
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