Label: SILACE - docusate sodium syrup

  • NDC Code(s): 54838-107-80
  • 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 60 mg (in each 15 mL (1 tablespoonful))

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  • PURPOSE

    Purpose: Stool Softener

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  • INDICATIONS & USAGE

    Uses

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

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  • WARNINGS

    Warnings

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

    Ask a doctor before use if you have

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

    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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  • DOSAGE & ADMINISTRATION


    Directions

    • take as directed by a doctor
    • doses must be given in a 6-8 oz glass of milk or fruit juice, to prevent throat irritation
    • dose may be taken as a single daily dose or in divided doses
    • dosage should be adjusted to individual response

    Adults and children 12 years of age and older
    1 to 6 tablespoonfuls, or as directed by a doctor
    Children 6 to under 12 years of age
    1 to 2 1/2 tablespoonfuls, or as directed by a doctor
    Children under 6 years
    Ask a doctor
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  • STORAGE AND HANDLING

    Other information

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

    Inactive ingredients:

    alcohol not more than 1%, citric acid, D&C red no. 33, FD&C red no. 40, peppermint flavor, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium benzoate, sodium citrate, sucrose.

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  • QUESTIONS

    Questions

    888-974-5279


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  • SPL UNCLASSIFIED SECTION

    Manufactured by:

    Silarx Pharmaceutical, Inc.

    1033 Stoneleigh Ave

    Carmel , NY 10512-USA.


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  • INGREDIENTS AND APPEARANCE
    SILACE 
    docusate sodium syrup
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:54838-107
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Docusate sodium (Docusate) Docusate sodium 60 mg  in 15 mL
    Inactive Ingredients
    Ingredient Name Strength
    alcohol  
    anhydrous citric acid  
    D&C red no. 33  
    FD&C red no. 40  
    glycerin  
    methylparaben  
    propylene glycol  
    propylparaben  
    water  
    sodium benzoate  
    sodium citrate  
    sucrose  
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor PEPPERMINT (peppermint Flavor) Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:54838-107-80 473 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 03/05/1990
    Labeler - Silarx Pharmaceuticals,Inc (161630033)
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