DOCUSATE SODIUM- docusate sodium capsule

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

Docusate Sodium (UNII: F05Q2T2JA0) (Docusate - UNII:M7P27195AG)

Dostopno od:

Pharbest Pharmaceuticals, Inc.

Pot uporabe:

ORAL

Tip zastaranja:

OTC DRUG

Terapevtske indikacije:

Stool softener - prevents/relieves dry hard stool - results usually occurs 1 to 3 days after the first dose

Status dovoljenje:

OTC monograph not final

Lastnosti izdelka

DOCUSATE SODIUM - DOCUSATE SODIUM CAPSULE
PHARBEST PHARMACEUTICALS, 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._
----------
DRUG FACTS
ACTIVE INGREDIENT (IN EACH SOFTGEL)
Docusate sodium 100 mg
PURPOS E
Stool softener
US ES
prevents/relieves dry hard stool
results usually occurs 1 to 3 days after the first dose
WARNINGS
DO NOT USE
when abdominal pain, nausea, or vomiting are present
for more than one week unless directed by a doctor
ASK A DOCTOR BEFORE USE IF YOU
are taking mineral oil
have noticed a sudden change in bowel habits that last over 2 weeks
STOP USE AND ASK A DOCTOR IF
you have no bowel movement after 3 days
you have rectal bleeding
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
do not exceed recommended dose
adults and children over
12 years
take 1-2 softgels daily until first
bowel movement; 1 softgel daily
12 years
thereafter
children 6 to 12 years
take 1 softgel daily
children under 6 years
consult a doctor
OTHER INFORMATION
TAMPER EVIDENT: DO NOT USE IF SAFETY SEAL UNDER CAP IS BROKEN OR
MISSING
store at room temperature 15 to 30 C (59 to 86 F)
protect from moisture
INACTIVE INGREDIENTS: D&C YELLOW # 10, FD&C RED # 40, GELATIN,
GLYCERIN, INK WHITE, POLYETHYLENE
GLYCOL, SORBITOL, PROPYLENE GLYCOL.
QUES TIONS ?
Adverse drug event call: [phone]
PRINCIPAL DISPLAY PANEL
*Compare to the active ingredient of Colace®
Docusate Sodium
Stool Softener
1000 SOFTGELS
100 mg each
DOCUSATE SODIUM
docusate sodium capsule
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:16 10 3-38 4
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
o
o
o
o
Pharbest Pharmaceuticals, Inc.
IN