SILACE- docusate sodium liquid

Silace by

Drug Labeling and Warnings

Silace by is a Otc medication manufactured, distributed, or labeled by Lannett Company, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

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

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

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

PREGNANCY OR BREAST FEEDING

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

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 years: 25 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.

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SILACE 
docusate sodium liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54838-116
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)	DOCUSATE SODIUM	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
WATER (UNII: 059QF0KO0R)
POLOXAMER 407 (UNII: TUF2IVW3M2)

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; Type 0: Not a Combination Product	10/05/1990

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part334	10/05/1990

Labeler - Lannett Company, Inc. (161630033)