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Silace

Silarx Pharmaceuticals, Inc

Silace Liquid


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient

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

Purpose

Purpose: Stool Softener

Silace 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

Ask 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

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

  • 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

Silace 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.

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

Silace

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 10 mg

Inactive Ingredients

Ingredient Name Strength
ANHYDROUS CITRIC ACID
D&C RED NO. 33
METHYLPARABEN
propylene glycol
PROPYLPARABEN
SODIUM CITRATE
water
POLOXAMER 407

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:54838-116-80 473 in 1 BOTTLE, PLASTIC

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part334 1990-10-05


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Be sure to consult your doctor before taking any medication!
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