DOCUSATE SODIUM capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Reliable 1 Laboratories LLC

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Stool softener laxative - relieves 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 bowel movement after use of a laxative. These could be sings of a serious condition. - you need to use a stool softener laxative for more than 1 week

Authorization status:

OTC monograph not final

Summary of Product characteristics

DOCUSATE SODIUM- DOCUSATE SODIUM CAPSULE
RELIABLE 1 LABORATORIES LLC
_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 100 MG
_DRUG FACTS_
_ACTIVE INGREDIENT (IN EACH SOFTGEL)_
Docusate sodium 100 mg
_PURPOSE_
Stool softener laxative
_USES_
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 directed 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
ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE taking any other
drug. Take this product two or
more hours before or after other drugs. Laxatives may affect how other
drugs work.
STOP USE AND ASK A DOCTOR IF
you have rectal bleeding or fail to have bowel movement after use of a
laxative. These could be
sings of a serious condition.
you need to use a stool softener laxative for more than 1 week
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_
adults and children 12 years and over
take 1 -3 softgels once daily or in divided doses
children 2 to under 12 years of age
1 softgel once daily
children under 2 years
ask a doctor
each softgel contains: SODIUM 5 MG
store at room temperature 15°-30°C (59°-86°F) and avoid excessive
heat
_INACTIVE INGREDIENTS_
citric acid, D&C red #33, FD&C blue #1, FD&C red #40, FD&C yellow #6,
gelatin, glycerin,
polyethylene glycol, propylene glycol, purified water, sorbitol
special and white edible ink
_QUESTIONS OR COMMENTS ?_
Call 516-341-066 8:30 am - 4:30 pm ET, Monday - Friday
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL UNDER CAP IS BROKEN OR
MISSING.
*Reliable-1 Laboratories LLC is not affilia