REGULOID- psyllium capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

PSYLLIUM HUSK (UNII: 0SHO53407G) (PSYLLIUM HUSK - UNII:0SHO53407G)

Available from:

Rugby Laboratories

INN (International Name):

PSYLLIUM HUSK

Composition:

PSYLLIUM HUSK 0.52 g

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Bulk-Forming Laxative - relieves occasional constipation - generally produces bowel movement in 12 to 72 hours

Authorization status:

OTC monograph not final

Summary of Product characteristics

REGULOID- PSYLLIUM CAPSULE
RUGBY LABORATORIES
_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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3860 - RUGBY
_DRUG FACTS_
ACTIVE INGREDIENT (IN EACH CAPSULE)
Psyllium husk (appx. 0.52 g)
PURPOS E
Bulk-Forming Laxative
US ES
relieves occasional constipation
generally produces bowel movement in 12 to 72 hours
WARNINGS
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.
DO NOT USE
longer than one week
ASK A DOCTOR BEFORE USE IF YOU HAVE
abdominal pain, nausea, or vomiting
noticed a sudden change in bowel habits that lasts over two 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 experience rectal bleeding
you fail to have a bowel movement after using this product.
These may indicate 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 with at least 8 ounces (a full glass) of water or
other fluid. Taking this product
without enough liquid may cause choking.
See choking warning.
ADULTS & CHILDREN 12 YEARS AND OVER: Take 5 capsules with 8 ounces of
liquid (swallow one
capsule at a time) at the first sign of irregularity. May be taken up
to 3 times daily
CHILDREN UNDER 12 YEARS: ask a doctor
Diets low in saturated fat and cholesterol that include 7 grams of
soluble fiber per day from psyllium
husk, as in Reguloid, may reduce the risk of heart disease.
SEE WARNINGS AND DIRECTIONS IN DRUG FACT