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  5. Label Information: Silace

FDA Label for Silace

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. USES
    4. WARNING
    5. OTC - ASK DOCTOR
    6. OTC - STOP USE
    7. OTC - PREGNANCY OR BREAST FEEDING
    8. OTC - KEEP OUT OF REACH OF CHILDREN
    9. DIRECTIONS
    10. OTHER INFORMATION
    11. INACTIVE INGREDIENTS
    12. OTC - QUESTIONS
    13. HOW SUPPLIED

Silace Product Label

The following document was submitted to the FDA by the labeler of this product Carilion Materials Management. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Active Ingredient



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


Otc - Purpose



Purpose: Stool Softener


Uses



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

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

Otc - 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

Otc - 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


Otc - Pregnancy Or Breast Feeding



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


Otc - 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.


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 years25 to 50 mg(1/2 to 1 teaspoonful)
    Children under 3 years of age
    		Ask a doctor

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

Inactive Ingredients



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


Otc - 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


How Supplied



Product: 68151-0116

NDC: 68151-0116-1 1 mL in a CUP, UNIT-DOSE


* Please review the disclaimer below.