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Silace

Physicians Total Care, Inc.

Silace syrup




FULL PRESCRIBING INFORMATION

Active ingredient

Active Ingredient: Docusate sodium 60 mg (in each 15 mL (1 tablespoonful))

Purpose

Purpose: Stool Softener

Uses

Uses

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

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

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

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 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

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

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.

Questions

888-974-5279


Manufactured by:

Silarx Pharmaceutical, Inc.

19 West Street

Spring Valley , NY 10977-USA.



Relabeling of additional barcode by:
Physicians Total Care, Inc.
Tulsa, OK       74146

SILACE (docusate sodium) syrup

473 mL (1 Pint)

NDC 54868-6311-0

Silace

Silace

Docusate sodium SYRUP

Product Information

Product Type Human otc drug label Item Code (Source) NDC:54868-6311(NDC:54838-107)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
DOCUSATE SODIUM DOCUSATE 60 mg

Inactive Ingredients

Ingredient Name Strength
ALCOHOL
Citric acid
D&C RED NO. 33
FD&C RED NO. 40
GLYCERIN
METHYLPARABEN
propylene glycol
PROPYLPARABEN
water
SODIUM BENZOATE
SODIUM CITRATE
SUCROSE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:54868-6311-0 473 in 1 BOTTLE, PLASTIC

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part334 2011-09-22


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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