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:

Bryant Ranch Prepack

INN (International Name):

DOCUSATE SODIUM

Composition:

DOCUSATE SODIUM 100 mg

Prescription type:

OTC DRUG

Authorization status:

OTC monograph not final

Summary of Product characteristics

DOCUSATE SODIUM- DOCUSATE SODIUM CAPSULE
BRYANT RANCH PREPACK
_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
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
These could be signs of a serious condition
you have no bowel movement after 3 days
you have rectal bleeding
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
thereafter
children 6 to 12 years
take 1 softgel daily
children under 6 years
consult a doctor
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]
DOCUSATE SODIUM 100MG CAPSULE
DOCUSATE SODIUM
docusate sodium capsule
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:6 36 29 -136 0 (NDC:16 10 3-38 4)
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
DO CUSATE SO DIUM (UNII: F0 5Q2T2JA0 ) (DOCUSATE - UNII:M7P2719 5AG)
DOCUSATE SODIUM
10 0 mg
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
D&C YELLO W NO . 10 (UNII: 35SW5USQ3G)
Bryant Ranch Prepack
FD&C RED NO . 4 0 (UNII: WZB9 127XOA)
GELATIN (UNII: 2G8 6 QN327L)
GLYCERIN (UNII: PDC6 A3C0 O