Label: STOOL SOFTENER- docusate sodium capsule, liquid filled 

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 04/14

If you are a consumer or patient please visit this version.

  • Active ingredient (in each softgel)

    Docusate Sodium 100 mg

    Close
  • Purpose

    Stool Softener Laxative

    Close
  • Uses

    relieves occasional constipation (irregularity)
    generally produces bowel movement in 12 to 72 hours
    Close
  • 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.

    Close
  • Directions

    • adults and children 12 years and older: take 1-2 softgels 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

    Close
  • 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.

    Close
  • Inactive ingredients

    FD and C red #40, gelatin, glycerin, edible ink, PEG, propylene glycol, sorbitol special, water. May also contain D and C yellow #10, FD and C yellow #6 (sunset yellow), mannitol.

    Compare to active ingredient in ColaceR*

    *This product is not manufactured or distributed by the owner of the registered trademark ColaceR.

    DIST. BY: GERI-CARE PHARMACUETICALS CORP.

    1650 63rd Street, Brooklyn, NY 11204

    REV 0112

    Cardinal Health

    Zanesville, OH 43701

    IT48469450613

    Close
  • Package Label

    Stool Softener

    Docusate Sodium

    100 mg each

    QTY 30 Softgels

    Blister label
    Close
  • Card Label

    Stool Softener

    Docusate Sodium

    100 mg each

    card label
    Close
  • INGREDIENTS AND APPEARANCE
    STOOL SOFTENER 
    docusate sodium capsule, liquid filled
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:55154-1876(NDC:57896-401)
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM 100 mg
    Inactive Ingredients
    Ingredient Name Strength
    FD&C RED NO. 40  
    GELATIN  
    GLYCERIN  
    POLYETHYLENE GLYCOL 400  
    PROPYLENE GLYCOL  
    SORBITOL  
    WATER  
    D&C YELLOW NO. 10  
    FD&C YELLOW NO. 6  
    MANNITOL  
    Product Characteristics
    Color red (reddish) Score no score
    Shape OVAL Size 12mm
    Flavor Imprint Code SCU1
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55154-1876-9 30 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part334 01/01/2000
    Labeler - Cardinal Health (188557102)
    Registrant - Geri-Care Pharmaceutical Corp (611196254)
    Establishment
    Name Address ID/FEI Business Operations
    Cardinal Health 188557102 REPACK(55154-1876)
    Close