Label: SILACE - docusate sodium liquid

  • NDC Code(s): 54838-116-80
  • Packager: Silarx Pharmaceuticals, Inc
  • 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 06/14

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

  • ACTIVE INGREDIENT

    Active Ingredient: Docusate sodium 10 mg (in each 1 mL)

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  • PURPOSE

    Purpose: Stool Softener

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  • Uses

    • for gentle, reliable relief from occasional constipation (irregularity)
    • generally produces bowel movement in 12 to 72 hours
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  • Warning

    • Do not use laxative products for longer than 1 week unless told to do so by a doctor
    • if you are presently taking mineral oil unless told to do by a doctor
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  • ASK DOCTOR

    Ask doctor before use if you have

    • stomach pain
    • nausea
    • vomiting
    • noticed a sudden change in bowel habits that last over two weeks
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  • STOP USE

    Stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition

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  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast feeding, ask a health professional before use.

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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

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  • Directions

    • take as indicated by doctor
    • this product must be given in a 6 to 8 oz. glass of milk or fruit juice or infant's formula to prevent throat irritation. Dose may be taken as a single daily dose or in divided doses
    • dosage should be adjusted to individual response
    • higher doses are recommended for initial therapy
    • the effect on stools is usually apparent 1 to 3 days after the first dose

    Adults and children over 12 years
    50 to 200 mg (1 to 4 teaspoonful)
    Children 6 to under 12 years
    50 to 100 mg (1 to 2 teaspoonful)
    Children 3 to under 6 years 25 to 50 mg(1/2 to 1 teaspoonful)
    Children under 3 years of age
    Ask a doctor
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  • Other information

    • store at room temperature 20°-25°C (68°-77°F)
    • protect from freezing and excessive heat
    • do not use if tamperevident safety seal around cap is broken or missing
    • dispense in tight, light-resistant container with a child-resistant closure
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  • Inactive ingredients

    citric acid, D&C red no. 33, flavor, methylparaben, Poloxamer, propylene glycol, propylparaben, purified water, sodium citrate.

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  • QUESTIONS

    Questions

    888-974-5279

    This product is not manufactured or distributed by Purdue Products LP, distributor of Colace® Liquid.

    Manufactured by:

    Silarx Pharmaceuticals, Inc.
    1033 Stoneleigh Ave
    Carmel, NY 10512
    USA

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  • INGREDIENTS AND APPEARANCE
    SILACE 
    docusate sodium liquid
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:54838-116
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Docusate sodium (Docusate) Docusate sodium 10 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    anhydrous citric acid  
    D&C red no. 33  
    methylparaben  
    propylene glycol  
    propylparaben  
    sodium citrate  
    water  
    Poloxamer 407  
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor LEMON (Lemon Vanilla Flavor) Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:54838-116-80 473 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part334 10/05/1990
    Labeler - Silarx Pharmaceuticals, Inc (161630033)
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