RxNorm Names
SILACE
(docusate sodium)
liquid
[Silarx Pharmaceuticals, Inc]
Permanent Link:
http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=38733915-c3a8-4e44-8453-5d4bd592f3f8| Category | DEA Schedule | Marketing Status |
|---|---|---|
| HUMAN OTC DRUG LABEL | OTC monograph not final |
NOTE: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.
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
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.
| SILACE
docusate sodium liquid |
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| Labeler - Silarx Pharmaceuticals, Inc (161630033) |
Revised: 12/2012
Document Id: 7385c57d-3c7c-4e47-9979-18dfe38d9c9c
Set id: 38733915-c3a8-4e44-8453-5d4bd592f3f8
Version: 10
Effective Time: 20121213
Silarx Pharmaceuticals, Inc
Review RxNorm Normal Forms