STOOL SOFTENER DC LAXATIVE- docusate calcium capsule, liquid filled

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DOCUSATE CALCIUM (UNII: 6K7YS503HC) (DOCUSATE - UNII:M7P27195AG)

Available from:

ATLANTIC BIOLOGICALS CORP.

INN (International Name):

DOCUSATE CALCIUM

Composition:

DOCUSATE CALCIUM 240 mg

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

for relief of occasional constipation. This product generally produces a bowel movement within 12 to 72 hours.

Authorization status:

OTC monograph not final

Summary of Product characteristics

STOOL SOFTENER DC LAXATIVE- DOCUSATE CALCIUM CAPSULE, LIQUID FILLED
ATLANTIC BIOLOGICALS CORP.
_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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DRUG FACTS
ACTIVE INGREDIENT (IN EACH SOFTGEL)
Docusate Calcium 240 mg
PURPOS E
Stool softener
US ES
for relief of occasional constipation. This product generally produces
a bowel movement within 12 to
72 hours.
WARNINGS
DO NOT USE
if you are currently taking mineral oil, unless directed by a doctor
when abdominal pain, nausea, or vomiting are present
for longer than 1 week, unless directed by a doctor
ASK A DOCTOR BEFORE USE IF
you notice a sudden change in bowel habits that persists over a period
of 2 weeks.
STOP USE AND ASK A DOCTOR IF
you have rectal bleeding
you fail to have a bowel movement after use
These could be signs of s serious condition.
IF PREGNANT OR BREAST-FEEDING,
ask a health care 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 OVER 12 YEARS OF AGE: take 1 softgel daily for
several days, or until bowel
movements are normal, or as directed by a doctor
CHILDREN UNDER 12 YEARS OF AGE: take as directed by a doctor
OTHER INFORMATION
store between 15º-30ºC (59º-86ºF)
INACTIVE INGREDIENTS
corn oil, D&C red #33, edible white ink, FD&C red #40, gelatin,
glycerin, purified water and sorbitol
special.
QUESTIONS OR COMMENTS?
1-800-645-2158
PRINCIPAL DISPLAY PANEL
Compare to active ingredient in SURFAK®*
Safe, Effective, Non-Habit Forming
Stool Softener Laxative DC
Docusate Calcium USP, 240 mg
SOFTGEL CAPSULES
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS
BROKEN OR MISSING
*RUGBY LABORATORIES IS NOT AFFILIATED WITH THE OWNER OF THE TRADEMARK
SURFAK®.
DISTRIBUTED BY: ATLANTIC BIOLOGICALS CORP
MIAMI, FL 33179
STOOL SOFTENER DC LAXATIVE
docusate calcium cap