DOCUSATE SODIUM liquid

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

Pharmaceutical Associates, Inc.

Designación común internacional (DCI):

Docusate Sodium

Composición:

Docusate Sodium 50 mg in 5 mL

Vía de administración:

ORAL

tipo de receta:

OTC DRUG

indicaciones terapéuticas:

Stool softener - relieves occasional constipation (irregularity) - generally produces bowel movement in 12 to 72 hours

Estado de Autorización:

OTC monograph not final

Ficha técnica

DOCUSATE SODIUM- DOCUSATE SODIUM LIQUID
PHARMACEUTICAL ASSOCIATES, INC.
_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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DOCUSATE SODIUM
_DRUG FACTS_
ACTIVE INGREDIENT (IN EACH 5 ML)
Docusate sodium 50 mg
PURPOS E
Stool softener
US ES
relieves occasional constipation (irregularity)
generally produces bowel movement in 12 to 72 hours
WARNINGS
DO NOT USE
if you are presently taking mineral oil, unless told to do so by a
doctor
ASK A DOCTOR BEFORE USE IF YOU HAVE
stomach pain
nausea
vomiting
noticed a sudden change in bowel habits that lasts over 2 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.
you need to use a stool softener laxative for more than 1 week
rash occurs
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
Dose once daily
take with 6 to 8 oz of milk, juice or infant formula to mask the
bitter taste.
adults and children 12 years
and older
5 to 20 mL (1 to 4
teaspoonfuls)
children 6 to under 12 years of 5 to 10 mL (1 to 2
age
teaspoonfuls)
children 3 to under 6 years of
age
2.5 to 5 mL (1/2 to 1
teaspoonful)
children under 3 years
ask a doctor
OTHER INFORMATION
Sodium content: 14 mg/ 5 mL
Store at controlled room temperature, 20° - 25°C (68° - 77°F)
Protect from freezing
Protect from light
Purple colored, cherry flavored liquid supplied in the following:
NDC 0121-0544-16: 16 fl oz (473 mL) bottle
NDC 0121-0544-10:
10 mL unit dose cup. Case contains 100
unit dose cups of 10 mL packaged in 10
trays of 10 unit dose cups each.
NDC 0121-0544-25:
25 mL unit dose cup. Case contains 100
unit dose cups of 25 mL packaged in 10
trays of 10 unit dose cups each.
INACTIVE INGREDIENTS
Citric ac