SILACE- docusate sodium liquid

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)

Available from:

Carilion Materials Management

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Purpose: Stool Softener - for gentle, reliable relief from occasional constipation (irregularity) - generally produces bowel movement in 12 to 72 hours 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

Product summary:

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

Authorization status:

OTC monograph not final

Summary of Product characteristics

SILACE - DOCUSATE SODIUM LIQUID
CARILION MATERIALS MANAGEMENT
_Disclaimer: Most OTC drugs are not reviewed and approved by FDA,
however they may be marketed if they_
_comply with applicable regulations and policies. FDA has not
evaluated whether this product complies._
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SILACE LIQUID
Active Ingredient: Docusate sodium 10 mg (in each 1 mL)
Purpose: Stool Softener
US ES
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
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
cit