SILACE- docusate sodium liquid

Silace by

Drug Labeling and Warnings

Silace by is a Otc medication manufactured, distributed, or labeled by ATLANTIC BIOLOGICALS CORP.. 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

17856-0116-02

INGREDIENTS AND APPEARANCE

SILACE 
docusate sodium liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 17856-0116(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: 17856-0116-2	25 mL in 1 CUP; Type 0: Not a Combination Product	10/07/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	10/05/1990

Labeler - ATLANTIC BIOLOGICALS CORP. (047437707)

Establishment
Name	Address	ID/FEI	Business Operations
ATLANTIC BIOLOGICALS CORP.		047437707	repack(17856-0116) , relabel(17856-0116)