CALCIUM POLYCARBOPHIL tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CALCIUM POLYCARBOPHIL (UNII: 8F049NKY49) (POLYCARBOPHIL - UNII:W25LM17A4W)

Available from:

SHANDONG XINHUA PHARMACEUTICAL CO., LTD.

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Bulk-forming laxative relieves occasional constipation (irregularity) generally produces bowel movement in 12 to 72 hours

Authorization status:

OTC monograph not final

Summary of Product characteristics

CALCIUM POLYCARBOPHIL- CALCIUM POLYCARBOPHIL TABLET, FILM COATED
SHANDONG XINHUA PHARMACEUTICAL CO., LTD.
_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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FIBER CAPLETS
CALCIUM POLYCARBOPHIL 625 MG
_DRUG FACTS_
_ACTIVE INGREDIENT (IN EACH CAPLET)_
Calcium polycarbophil 625 mg (equivalent to polycarbophil 500 mg)
_PURPOSE_
Bulk-forming laxative
_USES_
relieves occasional constipation (irregularity)
generally produces bowel movement in 12 to 72 hours
CHOKING: Taking this product without adequate fluid may cause it to
swell and block
your throat or esophagus and may cause choking. Do not take this
product if you have
difficulty in swallowing. If you experience chest pain, vomiting, or
difficulty in swallowing
or breathing after taking this product, seek immediate medical
attention.
ASK A DOCTOR BEFORE USE IF YOU HAVE
abdominal pain, nausea, or vomiting
difficulty in swallowing
a sudden change in bowel habits that persists over a period of 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.
WHEN USING THIS PRODUCT
do not use for more than 7 days unless directed by a doctor
do not take more than 8 caplets in a 24-hour period unless directed by
a doctor
STOP USE AND ASK A DOCTOR IF
you experience chest pain, abdominal pain, nausea, vomiting,
difficulty in breathing or
swallowing
you fail to have a bowel movement after use or have rectal bleeding.
These could be
signs of a serious condition.
KEEP OUT OF REACH OF CHILDREN.
In case of overdose, get medical help or contact a Poison Control
Center right away.
_DIRECTIONS_
take this product (child or adult dose) with a full glass of water
(8oz.) or other fluid.
Taking this product without enough liquid my cause choking. See
choking warning.
dosage will vary according to di